A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00853385
First received: February 27, 2009
Last updated: January 10, 2013
Last verified: January 2013
Results First Received: December 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: CP 690,550
Drug: CP-690,550
Other: Placebo
Biological: Biologic TNFi

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Participant Flow:   Overall Study
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
STARTED     204     201     56     52     204  
COMPLETED     150     158     47     39     162  
NOT COMPLETED     54     43     9     13     42  
Death                 0                 0                 0                 0                 1  
Adverse Event                 24                 24                 2                 5                 22  
Lack of Efficacy                 6                 7                 3                 3                 6  
Lost to Follow-up                 2                 1                 0                 0                 0  
Withdrawal by Subject                 4                 2                 0                 1                 1  
Unspecified                 18                 9                 4                 4                 12  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Total Total of all reporting groups

Baseline Measures
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab     Total  
Number of Participants  
[units: participants]
  204     201     56     52     204     717  
Age  
[units: years]
Mean ± Standard Deviation
  53.0  ± 11.9     52.9  ± 11.8     55.5  ± 13.7     51.9  ± 13.7     52.5  ± 11.7     52.9  ± 12.1  
Gender  
[units: participants]
           
Female     174     168     43     39     162     586  
Male     30     33     13     13     42     131  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6   [ Time Frame: Month 6 ]

Measure Type Primary
Measure Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Measure Description ACR20 response: greater than or equal to (>=) 20% improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame Month 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set: all randomized participants who received >=1 dose and had >=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  196     196     106     199  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6  
[units: percentage of participants]
  51.53     52.55     28.30     47.24  


Statistical Analysis 1 for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Groups [1] CP-690,550 10 mg vs. Placebo
Method [2] Normal approximation
P Value [3] <0.0001
Percent difference [4] 24.24
95% Confidence Interval ( 13.18 to 35.31 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Groups [1] CP-690,550 5 mg vs. Placebo
Method [2] Normal approximation
P Value [3] <0.0001
Percent difference [4] 23.22
95% Confidence Interval ( 12.16 to 34.29 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Groups [1] Placebo vs. Adalimumab
Method [2] Normal approximation
P Value [3] 0.0007
Percent difference [4] 18.93
95% Confidence Interval ( 7.90 to 29.96 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Statistical testing was done at 5% significance level (2-sided).
[4] Other relevant estimation information:
  No text entered.



2.  Primary:   Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3   [ Time Frame: Baseline, Month 3 ]

Measure Type Primary
Measure Title Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
Measure Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time Frame Baseline, Month 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  201     199     106     201  
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline (n=201, 199, 106, 201)     1.50  ± 0.64     1.53  ± 0.63     1.42  ± 0.68     1.50  ± 0.59  
Month 3 (n=188, 185, 98, 190)     -0.49  ± 0.59     -0.59  ± 0.58     -0.17  ± 0.56     -0.45  ± 0.52  


Statistical Analysis 1 for Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
Groups [1] CP-690,550 10 mg vs. Placebo
Method [2] Mixed Models Analysis
P Value [3] <0.0001
LS mean difference [4] -0.38
Standard Error of the mean ± 0.06
95% Confidence Interval ( -0.50 to -0.25 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
Groups [1] CP-690,550 5 mg vs. Placebo
Method [2] Mixed Models Analysis
P Value [3] <0.0001
LS mean difference [4] -0.31
95% Confidence Interval ( -0.43 to -0.19 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
Groups [1] Placebo vs. Adalimumab
Method [2] Mixed Models Analysis
P Value [3] <0.0001
LS mean difference [4] -0.25
95% Confidence Interval ( -0.37 to -0.13 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Statistical testing was done at 5% significance level (2-sided).
[4] Other relevant estimation information:
  No text entered.



3.  Primary:   Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6   [ Time Frame: Month 6 ]

Measure Type Primary
Measure Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
Measure Description DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame Month 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  177     176     92     178  
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6  
[units: percentage of participants]
  6.21     12.50     1.09     6.74  


Statistical Analysis 1 for Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
Groups [1] CP-690,550 10 mg vs. Placebo
Method [2] Normal approximation
P Value [3] <0.0001
Percent difference [4] 11.41
95% Confidence Interval ( 6.08 to 16.73 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
Groups [1] CP-690,550 5 mg vs. Placebo
Method [2] Normal approximation
P Value [3] 0.0151
Percent difference [4] 5.12
95% Confidence Interval ( 0.98 to 9.26 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
Groups [1] Placebo vs. Adalimumab
Method [2] Normal approximation
P Value [3] 0.0091
Percent difference [4] 5.65
95% Confidence Interval ( 1.40 to 9.90 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Statistical testing was done at 5% significance level (2-sided).
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3   [ Time Frame: Month 1, 3 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
Measure Description ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Month 1, 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  196     196     106     199  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3  
[units: percentage of participants]
       
Month 1     41.24     45.92     16.04     37.88  
Month 3     60.71     58.67     26.42     56.28  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3



5.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
Measure Description ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  196     196     56     50     199  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12  
[units: percentage of participants]
         
Month 9     49.49     50.51     30.36     36.00     47.24  
Month 12     49.49     49.49     33.93     34.00     49.25  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12



6.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
Measure Description ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  196     196     106     199  
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6  
[units: percentage of participants]
       
Month 1     14.95     16.33     4.72     12.12  
Month 3     34.18     27.55     6.60     23.62  
Month 6     36.73     34.69     12.26     27.64  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6



7.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
Measure Description ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  196     196     56     50     199  
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12  
[units: percentage of participants]
         
Month 9     35.71     37.24     17.86     26.00     29.15  
Month 12     36.73     35.71     21.43     28.00     33.67  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12



8.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
Measure Description ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  196     196     106     199  
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6  
[units: percentage of participants]
       
Month 1     2.58     4.08     0.94     3.03  
Month 3     12.24     14.80     1.89     8.54  
Month 6     19.90     21.94     1.89     9.05  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6



9.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
Measure Description ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  196     196     56     50     199  
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12  
[units: percentage of participants]
         
Month 9     18.37     21.94     8.93     10.00     11.06  
Month 12     22.96     23.47     10.71     14.00     16.58  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12



10.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Measure Description DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  200     199     106     201  
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline (n=200, 199, 106, 201)     5.43  ± 0.89     5.43  ± 0.83     5.44  ± 0.88     5.33  ± 0.92  
Month 1 (n=193, 196, 104, 197)     4.26  ± 1.09     4.21  ± 1.05     5.09  ± 1.15     4.27  ± 1.06  
Month 3 (n=187, 184, 99, 190)     3.78  ± 1.21     3.77  ± 1.21     4.83  ± 1.25     3.88  ± 1.15  
Month 6 (n=174, 180, 46, 181)     3.51  ± 1.27     3.29  ± 1.22     3.85  ± 1.14     3.63  ± 1.19  

No statistical analysis provided for Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6



11.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
Measure Description DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  160     167     49     41     171  
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12  
[units: units on a scale]
Mean ± Standard Deviation
         
Month 9 (n=160, 167, 49, 41, 171)     3.13  ± 1.11     3.20  ± 1.20     3.11  ± 1.11     3.03  ± 1.10     3.46  ± 1.21  
Month 12 (n=149, 150, 48, 37, 160)     3.05  ± 1.13     3.00  ± 1.18     3.12  ± 0.96     3.02  ± 1.28     3.18  ± 1.25  

No statistical analysis provided for Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12



12.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Measure Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  195     194     103     194  
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline (n=195, 194, 103, 194)     6.56  ± 0.93     6.48  ± 0.89     6.45  ± 0.90     6.36  ± 0.93  
Month 1 (n=172, 175, 90, 176)     5.23  ± 1.19     5.14  ± 1.26     5.93  ± 1.22     5.13  ± 1.21  
Month 3 (n=170, 166, 87, 167)     4.64  ± 1.33     4.66  ± 1.39     5.60  ± 1.31     4.66  ± 1.28  
Month 6 (n=155, 162, 41, 158)     4.40  ± 1.38     4.21  ± 1.38     4.61  ± 1.17     4.37  ± 1.30  

No statistical analysis provided for Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6



13.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12
Measure Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  140     151     45     35     149  
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12  
[units: units on a scale]
Mean ± Standard Deviation
         
Month 9 (n=140, 151, 45, 35, 149)     4.00  ± 1.21     4.08  ± 1.33     3.99  ± 1.25     3.93  ± 1.17     4.20  ± 1.39  
Month 12 (n=134, 136, 44, 32, 139)     3.85  ± 1.22     3.88  ± 1.35     4.00  ± 0.95     3.70  ± 1.24     3.95  ± 1.48  

No statistical analysis provided for Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12



14.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])   [ Time Frame: Baseline, Month 1, 3, 6, 9, 12 ]

Measure Type Secondary
Measure Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Measure Description DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6, 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  0     0     0     0  
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])                  

No statistical analysis provided for Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])



15.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])   [ Time Frame: Baseline, Month 1, 3, 6, 9, 12 ]

Measure Type Secondary
Measure Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Measure Description DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6, 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  0     0     0     0  
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])                  

No statistical analysis provided for Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])



16.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
Measure Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  194     196     106     198  
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 1 (n=194, 196, 106, 198)     1.15  ± 0.66     1.11  ± 0.67     1.32  ± 0.69     1.12  ± 0.64  
Month 3 (n=188, 185, 99, 190)     1.00  ± 0.72     0.94  ± 0.75     1.25  ± 0.67     1.05  ± 0.64  
Month 6 (n=174, 181, 46, 180)     0.92  ± 0.72     0.89  ± 0.69     1.15  ± 0.71     0.98  ± 0.65  

No statistical analysis provided for Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6



17.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
Measure Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  158     167     49     41     171  
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12  
[units: units on a scale]
Mean ± Standard Deviation
         
Month 9 (n=158, 167, 49, 41, 171)     0.86  ± 0.66     0.85  ± 0.66     0.89  ± 0.69     0.90  ± 0.64     0.97  ± 0.67  
Month 12 (n=149, 149, 49, 38, 159)     0.83  ± 0.68     0.81  ± 0.71     0.88  ± 0.71     0.91  ± 0.72     0.90  ± 0.67  

No statistical analysis provided for Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12



18.  Secondary:   Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Measure Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  201     199     106     201  
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6  
[units: mm]
Mean ± Standard Deviation
       
Baseline (n=201, 199, 106, 201)     59.29  ± 20.95     59.01  ± 22.18     55.20  ± 21.27     56.46  ± 21.92  
Month 1 (n=194, 196, 106, 198)     39.71  ± 22.60     36.77  ± 22.63     49.92  ± 23.94     39.27  ± 24.29  
Month 3 (n=188, 185, 99, 190)     32.98  ± 23.09     31.27  ± 22.39     48.53  ± 23.42     36.27  ± 25.67  
Month 6 (n=174, 181, 46, 179)     30.40  ± 23.26     28.36  ± 22.52     35.04  ± 20.95     32.78  ± 22.57  

No statistical analysis provided for Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6



19.  Secondary:   Patient Assessment of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Patient Assessment of Arthritis Pain at Month 9 and 12
Measure Description Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  158     167     49     41     171  
Patient Assessment of Arthritis Pain at Month 9 and 12  
[units: mm]
Mean ± Standard Deviation
         
Month 9 (n=158, 167, 49, 41, 171)     27.04  ± 21.35     27.99  ± 22.97     31.31  ± 22.66     24.93  ± 19.38     32.70  ± 24.18  
Month 12 (n=150, 150, 49, 38, 160)     26.99  ± 21.97     24.55  ± 20.68     28.23  ± 17.86     29.37  ± 20.57     27.94  ± 22.70  

No statistical analysis provided for Patient Assessment of Arthritis Pain at Month 9 and 12



20.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Measure Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  201     199     106     201  
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6  
[units: mm]
Mean ± Standard Deviation
       
Baseline (n=201, 199, 106, 201)     59.86  ± 21.38     56.55  ± 23.83     54.46  ± 21.27     57.22  ± 22.22  
Month 1 (n=194, 196, 105, 197)     41.85  ± 23.02     36.61  ± 23.51     50.70  ± 24.24     39.32  ± 23.83  
Month 3 (n=188, 185, 99, 190)     35.56  ± 23.81     31.25  ± 22.23     49.84  ± 22.45     36.97  ± 25.28  
Month 6 (n=174, 181, 46, 180)     32.79  ± 25.56     29.74  ± 22.41     37.76  ± 20.86     33.50  ± 21.97  

No statistical analysis provided for Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6



21.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Measure Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  158     167     49     41     171  
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12  
[units: mm]
Mean ± Standard Deviation
         
Month 9 (n=158, 167, 49, 41, 171)     28.39  ± 22.31     29.47  ± 21.99     31.78  ± 20.75     30.00  ± 20.31     34.38  ± 24.93  
Month 12 (n=149, 150, 49, 37, 160)     26.86  ± 22.44     27.70  ± 22.09     30.78  ± 17.65     29.70  ± 20.69     30.33  ± 24.46  

No statistical analysis provided for Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12



22.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Measure Description Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  199     199     106     201  
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6  
[units: mm]
Mean ± Standard Deviation
       
Baseline (n=199, 199, 106, 201)     59.92  ± 16.77     59.56  ± 16.70     60.28  ± 16.55     58.64  ± 15.98  
Month 1 (n=193, 195, 106, 197)     38.90  ± 18.56     36.16  ± 19.27     50.73  ± 22.08     38.81  ± 20.08  
Month 3 (n=186, 185, 99, 189)     30.28  ± 20.71     29.91  ± 21.04     45.12  ± 22.77     32.40  ± 21.08  
Month 6 (n=174, 180, 46, 178)     24.97  ± 19.26     24.46  ± 19.78     29.76  ± 20.43     27.77  ± 18.36  

No statistical analysis provided for Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6



23.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
Measure Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  160     167     49     41     170  
Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12  
[units: mm]
Mean ± Standard Deviation
         
Month 9 (n=160, 167, 49, 41, 170)     19.93  ± 16.20     21.92  ± 17.87     25.82  ± 20.32     23.78  ± 15.54     25.45  ± 19.94  
Month 12 (n=149, 150, 48, 38, 157)     18.67  ± 16.18     18.87  ± 16.05     19.77  ± 13.88     20.68  ± 14.51     20.44  ± 16.94  

No statistical analysis provided for Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12



24.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Measure Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  201     199     106     201  
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline: Physical functioning (n=201,199,106,201)     32.02  ± 9.48     31.06  ± 9.52     32.23  ± 9.43     31.74  ± 8.95  
Baseline: Role physical (n=201,199,106,201)     34.00  ± 9.11     33.54  ± 9.12     34.70  ± 8.01     34.79  ± 8.69  
Baseline: Social functioning (n=201,199,106,201)     36.15  ± 10.76     36.27  ± 11.59     39.36  ± 11.17     36.23  ± 11.52  
Baseline: Bodily pain (n=201,199,106,201)     33.42  ± 7.51     33.29  ± 7.42     34.53  ± 6.57     33.14  ± 7.33  
Baseline: Mental health (n=201,199,106,201)     39.04  ± 11.42     39.15  ± 11.19     41.11  ± 10.51     39.64  ± 11.19  
Baseline: Role emotional (n=201,199,106,201)     34.15  ± 12.49     34.11  ± 12.63     37.32  ± 11.97     35.54  ± 12.05  
Baseline: Vitality (n=201,199,106,201)     40.62  ± 9.23     40.79  ± 9.36     42.67  ± 8.85     39.95  ± 9.54  
Baseline: General health (n=201,199,106,201)     35.22  ± 8.95     35.81  ± 8.93     36.29  ± 8.38     35.18  ± 7.96  
Baseline:Mental component (n=201,199,106,201)     39.82  ± 11.68     40.21  ± 11.14     43.29  ± 10.58     40.58  ± 11.64  
Baseline: Physical component (n=201,199,106,201)     33.10  ± 7.69     32.62  ± 7.78     33.02  ± 6.23     32.74  ± 6.83  
Month 1: Physical functioning (n=194,196,106,198)     35.29  ± 9.94     35.23  ± 10.57     34.00  ± 9.68     35.38  ± 9.79  
Month 1: Role physical (n=194,196,106,198)     38.19  ± 9.34     38.45  ± 10.01     36.79  ± 9.39     38.37  ± 9.06  
Month 1: Social functioning (n=194,196,106,198)     40.77  ± 10.53     42.22  ± 10.64     41.74  ± 10.72     40.98  ± 10.41  
Month 1: Bodily pain (n=194,196,106,198)     40.14  ± 8.54     40.73  ± 8.46     36.18  ± 7.52     39.58  ± 8.36  
Month 1: Mental health (n=194,196,106,198)     42.31  ± 10.30     43.35  ± 11.13     41.79  ± 10.91     42.83  ± 10.93  
Month 1: Role emotional (n=194,196,106,198)     38.29  ± 12.54     38.64  ± 12.05     38.18  ± 11.89     39.10  ± 11.55  
Month 1: Vitality (n=194,196,106,198)     45.24  ± 9.33     46.99  ± 9.58     43.71  ± 8.74     44.44  ± 10.00  
Month 1: General health (n=194,196,106,198)     38.53  ± 9.24     39.98  ± 9.16     37.41  ± 8.61     38.35  ± 8.43  
Month 1: Mental component (n=194,196,106,198)     43.56  ± 10.60     44.92  ± 11.21     44.03  ± 11.04     44.05  ± 10.79  
Month 1: Physical component (n=194,196,106,198)     37.50  ± 7.99     37.86  ± 8.11     35.01  ± 7.36     37.08  ± 7.88  
Month 3: Physical functioning (n=187,185,99,190)     38.11  ± 10.39     38.49  ± 11.12     34.77  ± 8.92     36.56  ± 10.24  
Month 3: Role physical (n=188,185,99,190)     39.79  ± 9.55     40.93  ± 10.40     37.25  ± 8.88     39.51  ± 8.89  
Month 3: Social functioning (n=188,185,99,190)     41.59  ± 11.04     44.34  ± 11.00     41.41  ± 10.08     40.84  ± 10.92  
Month 3: Bodily pain (n=187,185,99,190)     41.08  ± 9.15     43.09  ± 9.58     37.05  ± 7.91     40.60  ± 9.54  
Month 3: Mental health (n=188,185,99,190)     42.43  ± 11.02     44.79  ± 11.25     42.44  ± 10.04     43.05  ± 10.45  
Month 3: Role emotional (n=188,185,99,190)     38.74  ± 12.56     41.76  ± 12.66     38.59  ± 12.42     39.24  ± 11.53  
Month 3: Vitality (n=188,185,99,190)     45.63  ± 9.91     48.09  ± 10.79     44.06  ± 9.22     45.57  ± 9.76  
Month 3: General health (n=188,185,99,189)     39.15  ± 9.52     41.35  ± 8.93     37.51  ± 8.08     39.33  ± 9.32  
Month 3: Mental component (n=187,185,99,189)     43.31  ± 11.47     46.49  ± 11.45     44.20  ± 10.65     43.90  ± 10.84  
Month 3: Physical component (n=187,185,99,189)     39.57  ± 8.76     40.30  ± 8.94     35.59  ± 7.33     38.58  ± 8.36  
Month 6: Physical functioning (n=173,181,46,179)     39.31  ± 10.92     38.56  ± 11.35     37.00  ± 8.99     37.29  ± 10.40  
Month 6: Role physical (n=173,181,46,179)     40.42  ± 10.03     41.29  ± 9.73     38.62  ± 7.95     39.99  ± 9.14  
Month 6: Social functioning (n=173,181,46,180)     43.85  ± 11.17     43.98  ± 11.30     42.49  ± 9.92     42.36  ± 10.43  
Month 6: Bodily pain (n=173,181,46,180)     42.79  ± 9.41     43.63  ± 9.31     39.79  ± 8.05     41.59  ± 8.95  
Month 6: Mental health (n=173,181,46,180)     44.31  ± 11.29     45.32  ± 11.43     41.21  ± 11.70     43.13  ± 11.35  
Month 6: Role emotional (n=173,181, 46,179)     40.78  ± 12.03     40.68  ± 11.77     39.22  ± 11.82     39.54  ± 11.85  
Month 6: Vitality (n=173,181,46,180)     47.35  ± 10.37     48.66  ± 10.08     45.06  ± 9.36     45.93  ± 9.88  
Month 6: General health (n=173,180,46,180)     40.53  ± 9.44     41.95  ± 8.89     39.03  ± 9.30     39.91  ± 8.72  
Month 6: Mental component (n=173,180,46,179)     45.44  ± 11.19     46.14  ± 11.43     43.43  ± 10.60     44.24  ± 11.69  
Month 6: Physical component (n=173,180,46,179)     40.45  ± 9.29     40.86  ± 8.71     38.44  ± 6.67     39.36  ± 8.39  

No statistical analysis provided for 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6



25.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

Measure Type Secondary
Measure Title 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Measure Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Time Frame Month 9, 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  159     167     49     41     171  
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12  
[units: units on a scale]
Mean ± Standard Deviation
         
Month 9: Physical functioning(n=158,167,49,41,171)     39.77  ± 10.29     38.74  ± 11.31     38.94  ± 9.81     38.59  ± 10.08     38.75  ± 10.23  
Month 9: Role physical (n=159,167,49,41,171)     41.66  ± 9.62     40.55  ± 10.15     41.77  ± 8.36     39.75  ± 9.20     41.12  ± 9.44  
Month 9: Social functioning (n=159,167,49,41,171)     43.52  ± 10.65     44.42  ± 9.96     44.55  ± 9.82     42.76  ± 9.78     42.03  ± 11.55  
Month 9: Bodily pain (n=159,166,49,41,171)     43.45  ± 9.02     42.75  ± 9.50     44.68  ± 8.86     42.26  ± 7.77     41.81  ± 9.73  
Month 9: Mental health (n=159,166,49,41,171)     44.47  ± 10.27     45.42  ± 10.44     44.83  ± 10.70     43.70  ± 10.16     43.44  ± 12.04  
Month 9: Role emotional (n=159,167,49,41,171)     39.98  ± 11.99     40.58  ± 12.07     39.84  ± 11.40     41.46  ± 11.81     40.07  ± 12.15  
Month 9: Vitality (n=159,166,49,41,171)     47.76  ± 9.51     48.69  ± 9.68     47.80  ± 8.94     46.41  ± 10.03     46.11  ± 10.28  
Month 9: General health (n=159,166,49,41,171)     41.15  ± 9.79     41.34  ± 9.20     41.39  ± 8.54     40.57  ± 9.34     40.12  ± 9.58  
Month9:Mental component (n=158,165,49,41,171)     44.79  ± 10.76     46.55  ± 10.52     45.31  ± 9.75     45.23  ± 11.22     44.08  ± 11.45  
Month 9: Physical component (n=158,165,49,41,171)     41.55  ± 8.57     40.32  ± 9.44     41.65  ± 8.20     39.73  ± 7.73     40.35  ± 8.31  
Month 12:Physical functioning(n=149,149,49,38,160)     40.16  ± 10.25     40.34  ± 11.59     39.24  ± 10.07     40.42  ± 9.84     39.21  ± 10.63  
Month 12: Role physical (n=150,150,49,38,160)     41.15  ± 9.35     42.34  ± 10.32     40.16  ± 8.73     41.18  ± 9.30     41.07  ± 9.29  
Month 12: Social functioning (n=150,150,49,38,160)     43.14  ± 10.46     44.07  ± 10.44     43.78  ± 9.97     44.94  ± 9.78     42.96  ± 10.92  
Month 12: Bodily pain (n=150,150,49,38,160)     43.44  ± 9.48     44.02  ± 10.02     43.90  ± 8.28     43.18  ± 7.76     42.73  ± 9.77  
Month 12: Mental health (n=150,149,49,38,159)     44.83  ± 10.02     45.06  ± 10.49     44.09  ± 9.20     45.28  ± 10.94     44.23  ± 10.93  
Month 12:Role emotional (n=150,150,49,38,159)     40.18  ± 11.46     42.25  ± 11.68     40.23  ± 10.79     41.03  ± 12.67     39.89  ± 11.63  
Month 12: Vitality (n=150,149,49,38,159)     47.60  ± 9.01     49.12  ± 9.95     47.31  ± 9.13     48.17  ± 9.36     46.27  ± 9.65  
Month 12:General health (n=150,150,49,38,160)     41.07  ± 9.85     42.33  ± 9.05     40.47  ± 9.44     40.77  ± 8.31     40.40  ± 9.13  
Month 12:Mental component (n=149,149,49,38,158)     45.02  ± 10.14     46.29  ± 10.56     45.02  ± 9.29     46.12  ± 11.75     44.42  ± 10.70  
Month 12: Physical component(n=149,149,49,38,158)     41.44  ± 8.81     41.96  ± 9.40     40.82  ± 8.01     41.12  ± 6.49     40.72  ± 8.84  

No statistical analysis provided for 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12



26.  Secondary:   Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
Measure Description FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  201     199     106     201  
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline (n=201, 199, 106, 201)     28.18  ± 10.48     28.56  ± 10.84     30.49  ± 10.23     27.95  ± 10.07  
Month 1 (n=192, 196, 106, 198)     32.54  ± 9.94     33.95  ± 10.54     31.66  ± 10.09     31.94  ± 10.48  
Month 3 (n=187, 185, 99, 190)     33.86  ± 10.18     35.12  ± 11.07     30.96  ± 10.21     32.72  ± 10.27  
Month 6 (n=173, 181, 46, 180)     34.58  ± 10.53     36.09  ± 10.07     32.37  ± 8.92     33.69  ± 10.58  

No statistical analysis provided for Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6



27.  Secondary:   Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
Measure Description FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  150     151     49     38     159  
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12  
[units: units on a scale]
Mean ± Standard Deviation
  35.76  ± 9.53     37.53  ± 10.41     36.71  ± 7.81     35.71  ± 9.65     34.30  ± 9.83  

No statistical analysis provided for Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12



28.  Secondary:   Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Measure Description Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  199     198     105     200  
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline: SPS (n=199, 198, 105, 200)     42.13  ± 20.58     40.20  ± 19.48     39.14  ± 19.04     40.90  ± 19.68  
Baseline: OSP (n=199, 198, 105, 200)     43.24  ± 19.91     42.27  ± 19.32     41.27  ± 19.47     43.12  ± 19.50  
Baseline: Ade (n=200, 198, 105, 200)     42.95  ± 27.92     44.04  ± 28.21     47.43  ± 26.06     44.25  ± 27.83  
Baseline: ASOB (n=200, 198, 105, 200)     19.10  ± 24.91     15.96  ± 21.70     18.67  ± 24.54     20.00  ± 24.31  
Baseline: SD (n=200, 198, 105, 200)     45.46  ± 26.30     44.67  ± 25.96     43.95  ± 27.40     46.55  ± 26.31  
Baseline: Qua (n=200, 198, 104, 199)     6.46  ± 1.36     6.61  ± 1.70     6.70  ± 1.51     6.65  ± 1.82  
Baseline: Sno (n=198, 197, 105, 199)     36.06  ± 31.78     34.62  ± 31.71     30.10  ± 28.16     34.77  ± 30.50  
Baseline: Som (n=199, 198, 105, 199)     36.52  ± 21.22     35.66  ± 22.28     36.70  ± 20.55     33.47  ± 19.68  
Month 1: SPS (n=194, 195, 105, 198)     36.25  ± 19.19     34.03  ± 18.74     37.62  ± 18.83     38.16  ± 20.30  
Month 1: OSP (n=194, 195, 105, 198)     36.70  ± 18.13     34.81  ± 18.64     38.77  ± 18.45     39.18  ± 19.67  
Month 1: Ade (n=194, 195, 105, 198)     48.97  ± 27.11     52.62  ± 27.62     49.81  ± 25.87     46.87  ± 27.30  
Month 1: ASOB (n=194, 195, 105, 198)     18.35  ± 22.52     14.56  ± 20.13     19.81  ± 23.78     18.69  ± 25.26  
Month 1: SD (n=194, 195, 105, 198)     36.52  ± 23.48     35.46  ± 24.25     40.43  ± 26.13     39.41  ± 25.42  
Month 1: Qua (n=193, 195, 105, 197)     6.70  ± 1.38     6.97  ± 1.49     6.74  ± 1.49     6.89  ± 1.55  
Month 1: Sno (n=194, 193, 104, 196)     36.08  ± 32.53     34.30  ± 29.56     31.35  ± 27.13     32.76  ± 28.19  
Month 1: Som (n=194, 195, 105, 198)     31.68  ± 21.26     31.04  ± 22.02     33.90  ± 21.80     33.91  ± 19.60  
Month 3: SPS (n=186, 185, 99, 190)     35.39  ± 18.66     32.86  ± 20.91     37.54  ± 19.18     37.21  ± 20.47  
Month 3: OSP (n=186, 185, 99, 190)     35.74  ± 18.30     33.44  ± 20.23     38.55  ± 18.97     38.32  ± 20.05  
Month 3: Ade (n=187, 185, 99, 190)     50.59  ± 27.67     53.24  ± 28.90     48.99  ± 28.16     49.21  ± 28.65  
Month 3: ASOB (n=187, 185, 99, 190)     18.18  ± 22.12     14.81  ± 20.62     18.59  ± 20.85     18.42  ± 24.42  
Month 3: SD (n=186, 185, 99, 190)     35.93  ± 24.29     32.86  ± 25.10     38.66  ± 26.24     39.95  ± 25.83  
Month 3: Qua (n=188, 185, 99, 190)     6.82  ± 1.32     7.03  ± 1.45     6.51  ± 1.56     6.83  ± 1.47  
Month 3: Sno (n=186, 184, 99, 189)     33.66  ± 30.78     34.35  ± 30.06     30.10  ± 22.92     34.60  ± 27.80  
Month 3: Som (n=187, 185, 99, 190)     29.41  ± 19.66     30.74  ± 22.65     36.50  ± 20.10     31.05  ± 20.26  
Month 6: SPS (n=173, 181, 46, 179)     32.66  ± 18.60     31.79  ± 18.64     36.52  ± 19.89     36.31  ± 19.25  
Month 6: OSP (n=173, 181, 46, 179)     33.28  ± 17.93     32.46  ± 18.50     36.87  ± 18.51     36.73  ± 19.04  
Month 6: Ade (n=173, 181, 46, 179)     53.12  ± 28.85     53.76  ± 27.87     50.00  ± 26.83     50.22  ± 27.33  
Month 6: ASOB (n=173, 181, 46, 179)     16.65  ± 22.00     13.48  ± 20.21     16.52  ± 20.79     19.22  ± 22.37  
Month 6: SD (n=173, 181, 46, 179)     32.95  ± 23.76     32.00  ± 24.30     37.31  ± 24.73     36.39  ± 24.20  
Month 6: Qua (n=173, 181, 45, 178)     6.86  ± 1.18     7.10  ± 1.60     6.71  ± 1.50     6.81  ± 1.36  
Month 6: Sno (n=171, 180, 46, 179)     31.46  ± 31.43     35.00  ± 29.13     23.91  ± 23.33     33.18  ± 27.32  
Month 6: Som (n=173, 181, 46, 179)     28.17  ± 17.55     30.39  ± 22.37     33.62  ± 17.72     31.84  ± 20.38  

No statistical analysis provided for Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6



29.  Secondary:   Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Measure Description Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  148     150     49     37     158  
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12  
[units: units on a scale]
Mean ± Standard Deviation
         
SPS (n=148, 150, 49, 37, 159)     34.62  ± 18.58     30.64  ± 18.42     34.69  ± 19.10     34.68  ± 21.32     35.72  ± 20.25  
OSP (n=148, 150, 49, 37, 158)     34.86  ± 17.87     31.49  ± 17.90     36.00  ± 17.63     35.38  ± 20.40     36.52  ± 19.68  
Ade (n=149, 150, 49, 37, 159)     51.21  ± 26.96     57.20  ± 28.48     54.29  ± 27.84     50.00  ± 30.18     49.81  ± 27.20  
ASOB (n=149, 150, 49, 37, 159)     16.78  ± 19.74     14.13  ± 20.67     21.22  ± 22.14     18.38  ± 18.49     17.48  ± 21.79  
SD (n=149, 150, 49, 37, 159)     34.82  ± 23.95     32.32  ± 22.41     37.12  ± 23.55     34.86  ± 23.94     37.36  ± 25.19  
Qua (n=148, 150, 49, 37, 158)     6.78  ± 1.19     7.03  ± 1.47     6.86  ± 1.34     6.84  ± 1.34     6.72  ± 1.31  
Sno (n=148, 150, 48, 37, 159)     33.78  ± 29.95     30.53  ± 27.29     27.50  ± 22.83     32.43  ± 26.81     34.47  ± 30.01  
Som (n=148, 150, 49, 37, 158)     29.41  ± 18.95     27.07  ± 19.36     32.38  ± 17.53     29.37  ± 22.25     30.00  ± 21.21  

No statistical analysis provided for Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12



30.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Measure Description MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  201     199     106     201  
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6  
[units: participants]
       
Baseline (n=201, 199, 106, 201)     94     94     49     88  
Month 1 (n=194, 196, 106, 198)     93     107     55     95  
Month 3 (n=188, 185, 99, 190)     100     110     37     93  
Month 6 (n=174, 181, 94, 182)     100     100     46     93  

No statistical analysis provided for Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6



31.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Measure Description MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time Frame Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  150     151     49     38     160  
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12  
[units: participants]
  80     84     28     19     75  

No statistical analysis provided for Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12



32.  Secondary:   Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

Measure Type Secondary
Measure Title Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
Measure Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame Baseline, Month 1, 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  200     199     106     201  
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline (n=200, 199, 106, 201)     0.43  ± 0.32     0.43  ± 0.32     0.50  ± 0.28     0.45  ± 0.29  
Month 1 (n=192, 195, 106, 198)     0.61  ± 0.23     0.60  ± 0.25     0.56  ± 0.25     0.58  ± 0.27  
Month 3 (n=187, 184, 99, 189)     0.62  ± 0.28     0.64  ± 0.28     0.55  ± 0.27     0.61  ± 0.26  
Month 6 (n=172, 180, 46, 178)     0.66  ± 0.26     0.65  ± 0.25     0.58  ± 0.28     0.64  ± 0.24  

No statistical analysis provided for Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6



33.  Secondary:   Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12
Measure Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  147     151     49     38     159  
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12  
[units: units on a scale]
Mean ± Standard Deviation
  0.69  ± 0.22     0.69  ± 0.22     0.68  ± 0.20     0.66  ± 0.19     0.66  ± 0.27  

No statistical analysis provided for Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12



34.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Month 3 and 6   [ Time Frame: Month 3, 6 ]

Measure Type Secondary
Measure Title Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Measure Description WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Time Frame Month 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  85     81     42     78  
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline: TMS (n=79, 77, 40, 76)     41.46  ± 23.42     42.09  ± 28.98     37.65  ± 23.69     46.43  ± 25.94  
Baseline: PDS (n=85, 76, 40, 77)     49.99  ± 23.16     52.14  ± 24.22     53.24  ± 23.62     44.51  ± 21.15  
Baseline: MIDS (n=82, 79, 41, 77)     26.80  ± 22.80     27.30  ± 22.32     24.85  ± 28.33     28.45  ± 23.77  
Baseline: ODS (n=80, 74, 40, 77)     36.34  ± 26.55     37.29  ± 28.16     29.28  ± 26.41     36.82  ± 22.71  
Baseline: WLI (n=85, 81, 42, 81)     9.76  ± 5.34     9.85  ± 5.67     8.83  ± 5.90     9.92  ± 5.01  
Month 3: TMS (n=74, 68, 40, 70)     31.31  ± 25.50     21.97  ± 25.52     34.26  ± 26.40     35.73  ± 28.50  
Month 3: PDS (n=77, 72, 39, 76)     53.03  ± 26.21     47.04  ± 33.97     55.57  ± 27.38     54.38  ± 28.15  
Month 3: MIDS (n=78, 72, 41, 73)     21.45  ± 22.03     15.14  ± 20.53     23.20  ± 26.04     22.64  ± 21.97  
Month 3: ODS (n=75, 70, 39, 76)     26.64  ± 23.61     19.31  ± 23.89     27.44  ± 25.18     26.57  ± 22.50  
Month 3: WLI (n=80, 74, 41, 78)     7.89  ± 5.12     5.92  ± 5.17     8.39  ± 5.73     8.23  ± 5.47  
Month 6: PDS (n=66, 65, 15, 71)     55.62  ± 30.05     53.57  ± 36.13     55.03  ± 29.84     52.17  ± 28.69  
Month 6: TMS (n=68, 65, 16, 67)     29.87  ± 26.81     21.30  ± 27.67     24.53  ± 24.19     29.70  ± 25.24  
Month 6: MIDS (n=70, 68, 16, 71)     17.50  ± 21.18     12.87  ± 22.77     18.26  ± 23.15     22.61  ± 22.38  
Month 6: ODS (n=67, 67, 16, 69)     23.18  ± 25.53     16.44  ± 23.79     19.69  ± 20.77     25.82  ± 22.93  
Month 6: WLI (n= 70, 69, 16, 73)     7.32  ± 5.47     5.69  ± 5.54     6.89  ± 4.90     7.84  ± 5.04  

No statistical analysis provided for Work Limitations Questionnaire (WLQ) Score at Month 3 and 6



35.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12   [ Time Frame: Baseline, Month 12 ]

Measure Type Secondary
Measure Title Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
Measure Description WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Time Frame Baseline, Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  57     55     21     14     60  
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12  
[units: units on a scale]
Mean ± Standard Deviation
         
TMS (n=55, 53, 20, 14, 57)     25.59  ± 25.10     20.77  ± 28.68     32.69  ± 29.07     28.75  ± 28.26     26.57  ± 26.68  
PDS (n=55, 52, 18, 14, 58)     54.35  ± 32.96     55.69  ± 38.22     51.81  ± 32.57     59.02  ± 36.59     50.41  ± 33.98  
MIDS (n=55, 51, 21, 14, 58)     14.72  ± 19.96     13.96  ± 23.76     21.46  ± 27.11     19.44  ± 24.29     17.99  ± 20.10  
ODS (n=57, 50, 19, 14, 58)     20.51  ± 23.13     17.35  ± 27.77     27.11  ± 27.29     25.36  ± 29.64     21.55  ± 22.63  
WLI (n=57, 55, 21, 14, 60)     6.61  ± 5.07     5.78  ± 5.59     7.75  ± 6.53     8.06  ± 6.01     6.85  ± 5.21  

No statistical analysis provided for Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12



36.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

Measure Type Secondary
Measure Title Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Measure Description Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Time Frame Baseline, Month 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  201     199     106     201  
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Baseline: Seen any doctor (n=201, 199, 106, 201)     1.16  ± 0.37     1.13  ± 0.34     1.15  ± 0.36     1.15  ± 0.36  
Baseline: Treated in ER (n=201, 199, 106, 201)     1.95  ± 0.23     1.93  ± 0.26     1.93  ± 0.25     1.94  ± 0.25  
Baseline: Admitted overnight stay (n=11,14,6,12)     0.45  ± 0.82     0.21  ± 0.43     0.17  ± 0.41     0.08  ± 0.29  
Baseline: Hospitalization (n=201, 199, 106, 201)     1.94  ± 0.24     1.97  ± 0.17     1.93  ± 0.25     1.95  ± 0.23  
Baseline: Outpatient surgeries (n=200,199,106,201)     1.96  ± 0.20     1.97  ± 0.17     1.98  ± 0.14     1.97  ± 0.18  
Baseline: Diagnostic tests (n=200,199,106,200)     1.81  ± 0.39     1.83  ± 0.37     1.82  ± 0.39     1.82  ± 0.39  
Baseline: In nursing home (n=201, 199, 106, 201)     1.99  ± 0.12     2.00  ± 0.00     2.00  ± 0.00     1.98  ± 0.14  
Baseline: Home HC services (n=201, 198, 106, 201)     1.99  ± 0.10     1.99  ± 0.10     1.99  ± 0.10     1.99  ± 0.12  
Baseline:Required aids/devices (n=201,199,106,201)     1.92  ± 0.28     1.86  ± 0.35     1.92  ± 0.28     1.91  ± 0.29  
Baseline: Seen NM practitioner (n=201,199,106,201)     1.99  ± 0.12     1.97  ± 0.17     1.98  ± 0.14     1.97  ± 0.17  
Baseline: Currently employed (n=201,199,106,201)     1.64  ± 0.48     1.65  ± 0.48     1.64  ± 0.48     1.65  ± 0.48  
Baseline: Feel well enough to work (n=73,83,39,81)     1.90  ± 0.30     1.89  ± 0.31     1.82  ± 0.39     1.80  ± 0.40  
Baseline: Retired (n=80,88,45,89)     1.41  ± 0.50     1.41  ± 0.49     1.40  ± 0.50     1.39  ± 0.49  
Baseline: Lost job/retired early(n=66,82,39,81)     1.50  ± 0.50     1.70  ± 0.46     1.74  ± 0.44     1.57  ± 0.50  
Baseline: Unable to work due to RA (n=76,84,40,78)     1.36  ± 0.48     1.37  ± 0.49     1.45  ± 0.50     1.37  ± 0.49  
Baseline: Work disabled due to RA (n=66,82,40,79)     1.56  ± 0.50     1.70  ± 0.46     1.70  ± 0.46     1.65  ± 0.48  
Baseline: Sick leave due to RA (n=167,166,92,167)     1.85  ± 0.36     1.86  ± 0.35     1.84  ± 0.37     1.83  ± 0.38  
Baseline: Part time work (n=169,166,92,167)     1.92  ± 0.27     1.92  ± 0.27     1.93  ± 0.25     1.94  ± 0.24  
Baseline: Performed paid work(n=169,166,91,167)     1.69  ± 0.46     1.70  ± 0.46     1.66  ± 0.48     1.67  ± 0.47  
Baseline: Unable to do chores (n=201,199,105,198)     1.41  ± 0.49     1.46  ± 0.50     1.53  ± 0.50     1.41  ± 0.49  
Baseline: Chores by housekeeper(n=201,199,106,201)     1.89  ± 0.32     1.90  ± 0.29     1.93  ± 0.25     1.91  ± 0.29  
Baseline: Chores by family (n=200,199,106,201)     1.50  ± 0.50     1.48  ± 0.50     1.62  ± 0.49     1.51  ± 0.50  
Month 3: Seen any doctor (n=186,185,99,190)     1.27  ± 0.45     1.28  ± 0.45     1.22  ± 0.42     1.29  ± 0.45  
Month 3: Treated in ER (n=186,185,99,190)     1.96  ± 0.20     1.96  ± 0.19     1.96  ± 0.20     1.95  ± 0.22  
Month 3: Admitted overnight stay (n=8,8,4,9)     0.25  ± 0.46     0.88  ± 0.99     0.00  ± 0.00     0.22  ± 0.44  
Month 3: Hospitalization (n=185,185,99,190)     1.98  ± 0.15     1.97  ± 0.16     1.99  ± 0.10     1.98  ± 0.12  
Month 3: Outpatient surgeries (n=185,185,99,190)     1.98  ± 0.13     1.98  ± 0.15     1.96  ± 0.20     1.97  ± 0.18  
Month 3: Diagnostic tests (n=184,185,99,190)     1.90  ± 0.30     1.87  ± 0.34     1.91  ± 0.29     1.89  ± 0.31  
Month 3: In nursing home (n=185,185,99,190)     1.99  ± 0.07     2.00  ± 0.00     2.00  ± 0.00     1.99  ± 0.10  
Month 3: Home HC services (n=184,185,99,190)     1.99  ± 0.07     2.00  ± 0.00     2.00  ± 0.00     2.00  ± 0.00  
Month 3: Required aids/devices (n=185,185,99,190)     1.94  ± 0.25     1.91  ± 0.29     1.92  ± 0.27     1.92  ± 0.28  
Month 3: Seen NM practitioner (n=185,185,99,190)     1.97  ± 0.16     2.00  ± 0.00     1.98  ± 0.14     1.98  ± 0.12  
Month 3: Currently employed (n=185,185,99,190)     1.62  ± 0.49     1.64  ± 0.48     1.63  ± 0.49     1.64  ± 0.48  
Month 3: Feel well enough to work (n=74,79,41,80)     1.70  ± 0.46     1.73  ± 0.44     1.93  ± 0.26     1.74  ± 0.44  
Month 3: Retired (n=80,86,47,86)     1.39  ± 0.49     1.34  ± 0.48     1.38  ± 0.49     1.38  ± 0.49  
Month 3: Lost job/retired early(n=73,78,40,79)     1.55  ± 0.50     1.59  ± 0.50     1.75  ± 0.44     1.65  ± 0.48  
Month 3: Unable to work due to RA (n=76,83,44,77)     1.42  ± 0.50     1.46  ± 0.50     1.45  ± 0.50     1.58  ± 0.50  
Month 3: Work disabled due to RA (n=71,82,41,73)     1.63  ± 0.49     1.68  ± 0.47     1.61  ± 0.49     1.74  ± 0.44  
Month 3: Sick leave due to RA (n=153,146,85,157)     1.93  ± 0.26     1.94  ± 0.24     1.81  ± 0.39     1.90  ± 0.29  
Month 3: Part time work (n=153,145,85,155)     1.95  ± 0.21     1.97  ± 0.16     1.94  ± 0.24     1.94  ± 0.25  
Month 3: Performed paid work(n=153,145,85,157)     1.73  ± 0.45     1.81  ± 0.39     1.68  ± 0.47     1.70  ± 0.46  
Month 3: Unable to do chores(n=182,182,99,189)     1.62  ± 0.49     1.71  ± 0.46     1.59  ± 0.50     1.66  ± 0.47  
Month 3: Chores by housekeeper (n=184,183,99,190)     1.91  ± 0.29     1.94  ± 0.24     1.93  ± 0.26     1.94  ± 0.24  
Month 3: Chores by family (n=183,183,99,190)     1.67  ± 0.47     1.74  ± 0.44     1.66  ± 0.48     1.68  ± 0.47  
Month 6: Seen any doctor (n=173,180,45,179)     1.25  ± 0.43     1.28  ± 0.45     1.27  ± 0.45     1.31  ± 0.46  
Month 6: Treated in ER (n=173,180,46,179)     1.93  ± 0.25     1.97  ± 0.18     1.91  ± 0.28     1.98  ± 0.15  
Month 6: Admitted overnight stay (n=12,6,4,3)     0.58  ± 0.67     0.17  ± 0.41     0.00  ± 0.00     0.00  ± 0.00  
Month 6: Hospitalization (n=172,180,46,179)     1.95  ± 0.22     1.97  ± 0.16     1.96  ± 0.21     1.99  ± 0.07  
Month 6: Outpatient surgeries (n=173,180,46,178)     1.98  ± 0.15     1.96  ± 0.19     1.98  ± 0.15     1.99  ± 0.11  
Month 6: Diagnostic tests (n=173,180,46,178)     1.87  ± 0.33     1.86  ± 0.35     1.89  ± 0.31     1.89  ± 0.31  
Month 6: In nursing home (n=173,180,46,178)     1.99  ± 0.11     2.00  ± 0.00     2.00  ± 0.00     2.00  ± 0.00  
Month 6: Home HC services (n=173,180,46,177)     1.99  ± 0.11     1.99  ± 0.11     2.00  ± 0.00     2.00  ± 0.00  
Month 6: Required aids/devices (n=173,180,46,178)     1.91  ± 0.28     1.91  ± 0.29     1.87  ± 0.34     1.92  ± 0.27  
Month 6: Seen NM practitioner (n=173,180,45,178)     2.00  ± 0.00     1.98  ± 0.13     2.00  ± 0.00     1.99  ± 0.07  
Month 6: Currently employed (n=173,180,46,179)     1.62  ± 0.49     1.66  ± 0.48     1.63  ± 0.49     1.63  ± 0.48  
Month 6: Feel well enough to work (72,81,23,76)     1.75  ± 0.44     1.77  ± 0.43     1.83  ± 0.39     1.71  ± 0.46  
Month 6: Retired (n=77,87,22,82)     1.32  ± 0.47     1.30  ± 0.46     1.32  ± 0.48     1.35  ± 0.48  
Month 6: Lost job/retired early (n=70,82,22,72)     1.57  ± 0.50     1.66  ± 0.48     1.68  ± 0.48     1.67  ± 0.47  
Month 6: Unable to work due to RA (n=73,83,23,74)     1.51  ± 0.50     1.54  ± 0.50     1.48  ± 0.51     1.57  ± 0.50  
Month 6: Work disabled due to RA (n=67,80,22,72)     1.72  ± 0.45     1.70  ± 0.46     1.73  ± 0.46     1.72  ± 0.45  
Month 6: Sick leave due to RA (n=138,134,38,144)     1.93  ± 0.25     1.93  ± 0.25     1.92  ± 0.27     1.94  ± 0.24  
Month 6: Part time work (n=135,134,37,142)     1.94  ± 0.24     1.96  ± 0.21     1.97  ± 0.16     1.95  ± 0.22  
Month 6: Performed paid work (n=136,136,38,142)     1.75  ± 0.43     1.80  ± 0.40     1.74  ± 0.45     1.76  ± 0.43  
Month 6: Unable to do chores(n=171,178,45,175)     1.70  ± 0.46     1.74  ± 0.44     1.62  ± 0.49     1.67  ± 0.47  
Month 6: Chores by housekeeper (n=172,180,45,180)     1.92  ± 0.27     1.94  ± 0.23     1.93  ± 0.25     1.96  ± 0.19  
Month 6: Chores by family (n=172,180,46,180)     1.72  ± 0.45     1.74  ± 0.44     1.67  ± 0.47     1.71  ± 0.45  

No statistical analysis provided for Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6



37.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Measure Description RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Time Frame Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  148     151     49     38     160  
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12  
[units: units on a scale]
Mean ± Standard Deviation
         
Seen any doctor (n=148,151,49,38,160)     1.31  ± 0.46     1.27  ± 0.45     1.24  ± 0.43     1.24  ± 0.43     1.23  ± 0.42  
Treated in ER (n=149,151,49,38,160)     1.98  ± 0.14     1.97  ± 0.18     2.00  ± 0.00     1.97  ± 0.16     1.96  ± 0.19  
Admitted overnight stay (n=3,5,0,1,6)     0.33  ± 0.58     0.20  ± 0.45     NA  ± NA [1]   0.00  ± NA [2]   0.17  ± 0.41  
Hospitalization (n=148,151,49,38,160)     1.98  ± 0.14     1.97  ± 0.18     1.98  ± 0.14     1.97  ± 0.16     1.98  ± 0.14  
Outpatient surgeries (n=148,151,49,38,160)     1.97  ± 0.18     1.99  ± 0.11     2.00  ± 0.00     1.95  ± 0.23     1.97  ± 0.17  
Diagnostic tests (n=149,151,49,38,159)     1.94  ± 0.24     1.87  ± 0.33     1.88  ± 0.33     1.84  ± 0.37     1.86  ± 0.35  
In nursing home (n=149,151,49,38,159)     1.99  ± 0.12     2.00  ± 0.00     2.00  ± 0.00     2.00  ± 0.00     1.99  ± 0.08  
Home HC services (n=148,151,49,38,159)     2.00  ± 0.00     2.00  ± 0.00     2.00  ± 0.00     2.00  ± 0.00     1.99  ± 0.08  
Required aids/devices (n=148,151,49,38,160)     1.93  ± 0.26     1.92  ± 0.27     1.94  ± 0.24     1.92  ± 0.27     1.91  ± 0.29  
Seen NM practitioner(n=149,151,49,38,160)     1.98  ± 0.14     1.97  ± 0.16     1.98  ± 0.14     1.95  ± 0.23     2.00  ± 0.00  
Currently employed (n=148,151,49,38,160)     1.59  ± 0.49     1.68  ± 0.47     1.61  ± 0.49     1.61  ± 0.50     1.64  ± 0.48  
Feel well enough to work (n=61,79,19,19,76)     1.72  ± 0.45     1.75  ± 0.44     1.84  ± 0.37     1.84  ± 0.37     1.68  ± 0.47  
Retired (n=64,84,21,19,80)     1.25  ± 0.44     1.31  ± 0.47     1.19  ± 0.40     1.53  ± 0.51     1.35  ± 0.48  
Lost job/retired early (n=58,75,19,18,75)     1.53  ± 0.50     1.72  ± 0.45     1.68  ± 0.48     1.78  ± 0.43     1.67  ± 0.47  
Unable to work due to RA (n=59,77,19,19,77)     1.56  ± 0.50     1.61  ± 0.49     1.58  ± 0.51     1.58  ± 0.51     1.57  ± 0.50  
Work disabled due to RA (n=58,76,19,18,75)     1.64  ± 0.48     1.75  ± 0.44     1.79  ± 0.42     1.67  ± 0.49     1.67  ± 0.47  
Sick leave due to RA (n=118,112,37,30,124)     1.96  ± 0.20     1.96  ± 0.19     1.95  ± 0.23     2.00  ± 0.00     1.97  ± 0.18  
Part time work (n=117,112,37,30,123)     1.95  ± 0.22     1.99  ± 0.09     2.00  ± 0.00     2.00  ± 0.00     1.99  ± 0.09  
Performed paid work (n=118,114,37,31,123)     1.83  ± 0.38     1.82  ± 0.39     1.78  ± 0.42     1.71  ± 0.46     1.82  ± 0.38  
Unable to do chores (n=146,150,47,38,154)     1.81  ± 0.40     1.75  ± 0.44     1.79  ± 0.41     1.84  ± 0.37     1.73  ± 0.45  
Chores by housekeeper (n=148,151,49,38,160)     1.94  ± 0.24     1.97  ± 0.16     1.96  ± 0.20     1.95  ± 0.23     1.93  ± 0.25  
Chores by family (n=145,151,49,38,160)     1.76  ± 0.43     1.80  ± 0.40     1.84  ± 0.37     1.71  ± 0.46     1.71  ± 0.45  
[1] Data not available as no participant was evaluable for the treatment arm at the given time point.
[2] Standard deviation was not estimable since only 1 participant was evaluable.

No statistical analysis provided for Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12



38.  Secondary:   Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

Measure Type Secondary
Measure Title Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Measure Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame Baseline, Month 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  168     174     90     172  
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6  
[units: events]
Mean ± Standard Deviation
       
Baseline: Doctor visits (n=168,174,90,172)     4.26  ± 3.51     4.06  ± 3.57     4.50  ± 5.32     3.87  ± 3.74  
Baseline: NM practitioners visits (n=3,6,2,6)     1.33  ± 0.58     3.00  ± 1.79     4.50  ± 4.95     10.00  ± 10.51  
Baseline: Hospital ER visits (n=12,14,7,12)     1.08  ± 0.51     1.93  ± 1.59     1.57  ± 0.79     1.58  ± 1.73  
Baseline: Number visits hospitalized(n=11,5,7,11)     2.82  ± 5.71     1.00  ± 0.00     1.00  ± 0.00     1.27  ± 0.90  
Baseline:Number of outpatient surgeries(n=8,6,2,7)     1.13  ± 0.35     1.33  ± 0.82     1.00  ± 0.00     2.57  ± 4.16  
Baseline:Non-study diagnostic tests(n=37,33,19,36)     1.73  ± 1.04     1.79  ± 1.17     1.21  ± 0.54     1.64  ± 1.10  
Baseline:RA related doctor visit(n=169,175,91,172)     1.33  ± 1.03     1.17  ± 0.70     1.26  ± 0.81     1.19  ± 0.73  
Baseline: RA related ER visit (n=11,14,6,12)     0.64  ± 0.81     0.64  ± 0.74     0.17  ± 0.41     0.25  ± 0.45  
Baseline: RA diagnostic tests (n=38,33,19,37)     0.50  ± 0.76     0.55  ± 0.62     0.47  ± 0.61     0.84  ± 0.73  
Baseline: RA related hospitalization (n=11,6,7,11)     0.91  ± 0.83     0.67  ± 0.52     0.57  ± 0.79     0.82  ± 0.60  
Baseline: RA related outpatient surgery(n=7,6,3,7)     0.43  ± 0.79     0.33  ± 0.82     0.33  ± 0.58     0.43  ± 0.79  
Baseline: RA related NM visit (n=3,6,2,6)     0.67  ± 0.58     0.50  ± 0.84     1.00  ± 0.00     1.00  ± 0.63  
Month 3: Doctor visits (n=136,138,78,136)     3.62  ± 4.25     2.86  ± 2.99     3.27  ± 3.93     3.05  ± 2.87  
Month 3: NM practitioners visits (n=5,0,2,2)     2.40  ± 0.89     NA  ± NA [1]   17.00  ± 21.21     7.50  ± 9.19  
Month 3: Hospital ER visits (n=8,8,4,10)     1.38  ± 0.74     1.00  ± 0.00     1.75  ± 1.50     1.90  ± 1.10  
Month 3: Number visits hospitalized (n=4,6,1,3)     1.50  ± 1.00     1.00  ± 0.00     1.00  ± NA [2]   1.00  ± 0.00  
Month 3: Number of outpatient surgeries(n=3,4,4,6)     1.67  ± 0.58     1.00  ± 0.00     1.00  ± 0.00     1.33  ± 0.52  
Month 3: Non-study diagnostic tests (n=18,23,9,20)     1.72  ± 1.41     1.52  ± 0.79     1.56  ± 0.88     1.45  ± 0.83  
Month 3: RA related doctor visit(n=136,138,78,136)     0.91  ± 0.75     0.92  ± 0.67     0.90  ± 0.71     0.93  ± 0.65  
Month 3: RA related ER visit (n=8,8,4,9)     0.25  ± 0.46     0.50  ± 0.76     0.00  ± 0.00     0.00  ± 0.00  
Month 3: RA-diagnostic tests (n=19,24,9,21)     0.11  ± 0.32     0.21  ± 0.51     0.11  ± 0.33     0.24  ± 0.44  
Month 3: RA related hospitalization (n=4,6,1,3)     0.00  ± 0.00     0.17  ± 0.41     0.00  ± NA [3]   0.67  ± 1.15  
Month 3: RA related outpatient surgery (n=3,4,4,6)     0.00  ± 0.00     0.25  ± 0.50     0.25  ± 0.50     0.00  ± 0.00  
Month 3: RA related NM visit (n=5,0,2,2)     0.60  ± 0.89     NA  ± NA [1]   1.50  ± 0.71     0.50  ± 0.71  
Month 6: Doctor visits (n=132,131,33,128)     3.30  ± 4.17     2.86  ± 4.23     2.52  ± 1.91     2.73  ± 2.96  
Month 6: NM practitioners visits (n=1,3,0,1)     1.00  ± NA [2]   2.67  ± 2.89     NA  ± NA [1]   14.00  ± NA [2]
Month 6: Hospital ER visits (n=12,6,4,4)     1.08  ± 0.29     1.17  ± 0.41     1.00  ± 0.00     1.75  ± 0.96  
Month 6: Number visits hospitalized (n=9,5,2,1)     1.00  ± 0.00     1.00  ± 0.00     1.00  ± 0.00     1.00  ± NA [2]
Month 6: Number of outpatient surgeries(n=4,7,1,2)     1.25  ± 0.50     1.14  ± 0.38     1.00  ± NA [2]   1.50  ± 0.71  
Month 6: Non-study diagnostic tests (n=21,25,5,19)     2.33  ± 3.89     1.96  ± 1.31     1.80  ± 0.45     1.53  ± 0.61  
Month 6: RA related doctor visit(n=132,131,33,129)     0.81  ± 0.63     0.96  ± 0.74     0.88  ± 0.86     1.00  ± 0.56  
Month 6: RA related ER visit (n=12,6,4,3)     0.25  ± 0.62     0.67  ± 0.82     0.00  ± 0.00     0.00  ± 0.00  
Month 6: RA-diagnostic tests (n=21,25,5,19)     0.18  ± 0.50     0.16  ± 0.37     0.20  ± 0.45     0.11  ± 0.32  
Month 6: RA related hospitalization (n=9,5,2,1)     0.22  ± 0.67     0.40  ± 0.89     0.00  ± 0.00     0.00  ± NA [3]
Month 6: RA related outpatient surgery (n=4,7,1,2)     0.00  ± 0.00     0.43  ± 0.79     0.00  ± NA [3]   1.00  ± 1.41  
Month 6: RA related NM visit (n=1,3,0,1)     0.00  ± NA [3]   0.67  ± 1.15     NA  ± NA [1]   0.00  ± NA [4]
[1] Data not available as no participant was evaluable for the treatment arm at the given time point.
[2] Standard deviation was not estimable since only 1 participant was evaluable.
[3] Standard deviation was not estimable since only 1 participant were evaluable.
[4] Standard deviation was not estimable as only 1 participant was evaluable.

No statistical analysis provided for Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6



39.  Secondary:   Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Measure Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  104     111     37     30     125  
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12  
[units: events]
Mean ± Standard Deviation
         
Doctor visit (n=102,111,37,30,125)     2.73  ± 2.78     2.80  ± 2.46     3.92  ± 5.97     3.50  ± 3.34     2.94  ± 3.93  
NM practitioners visits (n=3,4,1,2,0)     10.67  ± 11.72     9.75  ± 10.97     192.00  ± NA [1]   10.50  ± 6.36     NA  ± NA [2]
Hospital ER visits (n=3,5,0,1,6)     1.00  ± 0.00     2.40  ± 1.34     NA  ± NA [2]   3.00  ± NA [1]   1.00  ± 0.00  
Number of visits hospitalized (n=3,5,1,1,3)     1.00  ± 0.00     1.00  ± 0.00     1.00  ± NA [1]   1.00  ± NA [1]   1.00  ± 0.00  
Number of outpatient surgeries (n=5,2,0,2,5)     1.40  ± 0.89     1.50  ± 0.71     NA  ± NA [2]   1.00  ± 0.00     2.20  ± 2.17  
Non-study diagnostic tests (n=8,19,6,6,22)     1.13  ± 0.35     1.95  ± 1.31     3.17  ± 2.64     1.33  ± 0.82     1.64  ± 0.90  
RA related doctor visit (n=104,111,37,30,125)     0.82  ± 0.59     0.93  ± 0.57     0.89  ± 0.52     0.87  ± 0.68     0.84  ± 0.80  
RA related ER visits (n=3,5,0,1,6)     0.33  ± 0.58     0.00  ± 0.00     NA  ± NA [2]   0.00  ± NA [1]   0.17  ± 0.41  
RA-diagnostic tests (n=9,19,6,6,22)     0.11  ± 0.33     0.21  ± 0.42     0.17  ± 0.41     0.00  ± 0.00     0.05  ± 0.21  
RA related hospitalization (n=3,5,1,1,3)     0.00  ± 0.00     0.00  ± 0.00     0.00  ± NA [3]   0.00  ± NA [3]   0.67  ± 0.58  
RA related outpatient surgery (n=5,2,0,2,5)     0.00  ± 0.00     0.00  ± 0.00     NA  ± NA [2]   0.00  ± 0.00     0.00  ± 0.00  
RA related NM visits (n=3,4,1,2,0)     0.00  ± 0.00     0.50  ± 1.00     0.00  ± NA [4]   0.00  ± 0.00     NA  ± NA [2]
[1] Standard deviation was not estimable since only 1 participant was evaluable.
[2] Data not available as no participant was evaluable for the treatment arm at the given time point.
[3] Standard deviation was not estimable since only 1 participant were evaluable.
[4] Standard deviation was not estimable as only 1 participant was evaluable.

No statistical analysis provided for Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12



40.  Secondary:   Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

Measure Type Secondary
Measure Title Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Measure Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame Baseline, Month 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  101     102     39     97  
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6  
[units: days]
Mean ± Standard Deviation
       
Baseline: Hospital length of stay (n=11,6,7,11)     13.64  ± 12.91     10.83  ± 9.89     13.43  ± 9.78     12.82  ± 10.93  
Baseline: Days in nursing home (n=3,0,0,4)     19.33  ± 17.56     NA  ± NA [1]   NA  ± NA [1]   14.25  ± 9.95  
Baseline: Days devices/aids used (n=17,28,8,16)     133.88  ± 111.17     67.32  ± 61.88     172.75  ± 94.28     66.13  ± 65.33  
Baseline: Days of work per week (n=71,69,38,70)     4.94  ± 1.18     4.80  ± 1.05     4.95  ± 0.98     5.01  ± 1.04  
Baseline: Chores by housekeeper (n=23,19,6,18)     15.57  ± 25.73     14.95  ± 27.24     38.83  ± 41.44     6.94  ± 6.86  
Baseline: Chores by family (n=101,102,39,97)     24.06  ± 29.27     26.57  ± 31.02     26.95  ± 32.87     29.80  ± 32.91  
Baseline: Days on sick leave (n=24,24,15,29)     19.58  ± 27.78     16.33  ± 27.21     29.60  ± 34.88     16.31  ± 26.05  
Baseline: Days of part time work (n=13,13,6,10)     13.31  ± 18.94     25.31  ± 61.19     5.33  ± 3.44     18.50  ± 26.88  
Baseline: Paid work, bothered by RA(n=51,47,31,53)     29.10  ± 27.47     29.45  ± 31.37     28.74  ± 28.76     42.74  ± 31.81  
Baseline: RA related devices/aids (n=17,28,9,17)     1.76  ± 1.15     1.39  ± 0.69     2.33  ± 1.66     1.65  ± 1.06  
Month 3: Hospital length of stay (n=4,6,1,3)     6.25  ± 4.03     10.00  ± 10.75     2.00  ± NA [2]   10.33  ± 8.14  
Month 3: Days in nursing home (n=0,0,0,2)     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   17.50  ± 4.95  
Month 3: Days devices/aids used (n=11,17,6,15)     117.91  ± 112.91     60.41  ± 88.79     163.83  ± 153.63     91.80  ± 95.18  
Month 3: Days of work per week (n=70,66,38,68)     4.83  ± 0.95     4.68  ± 1.18     4.95  ± 0.80     4.75  ± 1.25  
Month 3: Chores by housekeeper (n=17,11,7,12)     12.59  ± 23.15     6.00  ± 8.63     8.00  ± 12.54     10.50  ± 16.08  
Month 3: Chores by family (n=60,47,34,58)     24.10  ± 32.38     18.32  ± 24.03     24.97  ± 31.72     25.41  ± 30.46  
Month 3: Days on sick leave (n=11,9,17,15)     24.27  ± 33.73     18.44  ± 29.37     27.12  ± 31.42     5.13  ± 4.60  
Month 3: Days of part time work (n=7,4,6,10)     13.29  ± 13.76     25.50  ± 27.77     5.50  ± 3.27     14.90  ± 27.04  
Month 3: Paid work, bothered by RA (n=39,28,28,44)     16.08  ± 21.77     26.57  ± 32.41     19.93  ± 20.79     33.61  ± 30.31  
Month 3: RA related devices/aids (n=12,17,8,16)     1.75  ± 1.22     1.12  ± 1.36     2.38  ± 1.60     1.81  ± 0.98  
Month 6: Hospital length of stay (n=9,5,2,1)     10.00  ± 8.20     12.80  ± 16.71     8.50  ± 2.12     6.00  ± NA [2]
Month 6: Days in nursing home (n=2,0,0,0)     27.00  ± 18.38     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]
Month 6: Days devices/aids used (n=14,16,5,14)     102.29  ± 115.01     126.25  ± 134.08     80.20  ± 73.45     94.21  ± 76.92  
Month 6: Days of work per week (n=65,61,17,66)     4.94  ± 0.85     4.70  ± 1.09     5.35  ± 0.93     4.95  ± 0.92  
Month 6: Chores by housekeeper (n=11,10,3,7)     7.73  ± 8.25     15.80  ± 22.73     44.00  ± 42.57     7.29  ± 3.82  
Month 6: Chores by family (n=46,46,15,50)     13.59  ± 16.95     29.09  ± 35.16     35.53  ± 39.39     22.64  ± 29.51  
Month 6: Days on sick leave (n=7,9,3,9)     29.57  ± 41.48     12.44  ± 14.60     3.00  ± 2.00     8.67  ± 13.13  
Month 6: Days of part time work (n=7,6,1,7)     7.57  ± 6.80     24.67  ± 33.07     4.00  ± NA [2]   9.29  ± 8.67  
Month 6: Paid work, bothered by RA (n=31,25,10,33)     14.71  ± 18.47     20.40  ± 25.93     11.00  ± 9.13     24.55  ± 26.88  
Month 6: RA related devices/aids (n=15,16,6,14)     2.00  ± 1.73     1.56  ± 1.46     2.17  ± 1.83     2.07  ± 1.27  
[1] Data not available as no participant was evaluable for the treatment arm at the given time point.
[2] Standard deviation was not estimable since only 1 participant was evaluable.

No statistical analysis provided for Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6



41.  Secondary:   Number of Days as Assessed Using RA-HCRU at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Number of Days as Assessed Using RA-HCRU at Month 12
Measure Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  60     49     19     15     58  
Number of Days as Assessed Using RA-HCRU at Month 12  
[units: days]
Mean ± Standard Deviation
         
Hospital length of stay (n=3,5,1,1,3)     8.00  ± 6.93     5.60  ± 2.70     15.00  ± NA [1]   1.00  ± NA [1]   15.33  ± 4.51  
Days in nursing home (n=2,0,0,0,1)     24.50  ± 4.95     NA  ± NA [2]   NA  ± NA [2]   NA  ± NA [2]   10.00  ± NA [1]
Days devices/aids used (n=11,12,3,2,15)     144.55  ± 258.85     51.75  ± 41.51     163.67  ± 173.70     321.50  ± 327.39     79.33  ± 74.00  
Days of work per week (n=60,49,19,15,58)     4.83  ± 1.04     5.04  ± 0.93     5.16  ± 0.90     4.93  ± 0.70     4.95  ± 1.07  
Chores by housekeeper (n=9,4,1,2,10)     4.44  ± 3.40     7.75  ± 5.06     90.00  ± NA [1]   24.00  ± 16.97     4.90  ± 3.78  
Chores by family (n=35,30,8,10,45)     22.06  ± 27.84     13.13  ± 12.28     51.88  ± 40.91     28.40  ± 33.88     23.49  ± 28.68  
Days on sick leave (n=5,3,2,0,4)     10.40  ± 11.41     36.00  ± 45.97     50.00  ± 56.57     NA  ± NA [2]   18.25  ± 14.06  
Days of part time work (n=6,1,0,0,1)     11.33  ± 12.55     33.00  ± NA [1]   NA  ± NA [2]   NA  ± NA [2]   30.00  ± NA [1]
Paid work, bothered by RA (n=20,20,7,9,22)     24.10  ± 30.75     20.40  ± 27.90     11.43  ± 8.60     12.33  ± 12.32     22.86  ± 24.20  
RA related devices/aids used (n=11,12,3,3,15)     2.18  ± 2.79     0.75  ± 0.62     2.33  ± 1.53     3.00  ± 2.65     1.53  ± 0.74  
[1] Standard deviation was not estimable since only 1 participant was evaluable.
[2] Data not available as no participant was evaluable for the treatment arm at the given time point.

No statistical analysis provided for Number of Days as Assessed Using RA-HCRU at Month 12



42.  Secondary:   Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

Measure Type Secondary
Measure Title Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Measure Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Time Frame Baseline, Month 3, 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  101     102     39     95  
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6  
[units: hours per day]
Mean ± Standard Deviation
       
Baseline: Home HC services (n=2,2,1,2)     3.00  ± 2.83     1.50  ± 0.71     2.00  ± NA [1]   1.00  ± 0.00  
Baseline: Work done (n=72,69,38,70)     7.76  ± 2.40     7.54  ± 2.25     7.79  ± 1.76     8.16  ± 2.85  
Baseline: Chores by housekeeper (n=22,19,7,18)     5.23  ± 4.60     5.53  ± 5.36     8.00  ± 7.55     3.89  ± 2.37  
Baseline: Chores by family (n=101,102,39,95)     4.24  ± 4.75     3.31  ± 2.76     4.21  ± 4.71     2.82  ± 1.79  
Baseline: Missed work due to RA (n=13,13,6,10)     6.38  ± 7.22     5.00  ± 5.85     4.00  ± 1.26     4.00  ± 4.11  
Baseline: RA related home HC services (n=2,2,1,3)     0.50  ± 0.71     1.00  ± 0.00     1.00  ± NA [1]   0.33  ± 0.58  
Month 3: Home HC services (n=1,0,0,0)     1.00  ± NA [1]   NA  ± NA [2]   NA  ± NA [2]   NA  ± NA [2]
Month 3: Work done (n=70,66,38,68)     8.06  ± 3.59     7.53  ± 1.92     8.53  ± 5.62     8.38  ± 4.89  
Month 3: Chores by housekeeper (n=17,11,7,12)     4.00  ± 2.12     5.73  ± 2.61     5.00  ± 2.00     4.17  ± 1.99  
Month 3: Chores by family (n=59,46,34,59)     3.46  ± 3.67     3.28  ± 2.60     3.41  ± 2.72     3.68  ± 3.72  
Month 3: Missed work due to RA (n=7,4,6,9)     4.57  ± 5.03     20.75  ± 39.51     5.50  ± 5.01     3.56  ± 1.59  
Month 3: RA related home HC services (n=1,0,0,0)     1.00  ± NA [1]   NA  ± NA [2]   NA  ± NA [2]   NA  ± NA [2]
Month 6: Home HC services (n=2,2,0,0)     2.50  ± 2.12     16.00  ± 5.66     NA  ± NA [2]   NA  ± NA [2]
Month 6: Work done (n=65,61,17,66)     8.35  ± 4.46     7.72  ± 2.24     9.71  ± 7.59     8.00  ± 4.27  
Month 6: Chores by housekeeper (n=11,10,3,7)     3.36  ± 2.58     5.40  ± 2.50     5.33  ± 1.53     6.29  ± 7.95  
Month 6: Chores by family (n=47,45,13,51)     3.30  ± 2.69     2.91  ± 2.00     3.69  ± 2.32     3.33  ± 3.55  
Month 6: Missed work due to RA (n=7,6,1,7)     4.57  ± 5.19     3.17  ± 2.32     5.00  ± NA [1]   3.29  ± 1.70  
Month 6: RA related home HC services (n=2,2,0,0)     1.00  ± 1.41     0.50  ± 0.71     NA  ± NA [2]   NA  ± NA [2]
[1] Standard deviation was not estimable since only 1 participant was evaluable.
[2] Data not available as no participant was evaluable for the treatment arm at the given time point.

No statistical analysis provided for Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6



43.  Secondary:   Number of Hours Per Day as Assessed RA-HCRU at Month 12   [ Time Frame: Month 12 ]

Measure Type Secondary
Measure Title Number of Hours Per Day as Assessed RA-HCRU at Month 12
Measure Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Time Frame Month 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Adalimumab  
Number of Participants Analyzed  
[units: participants]
  60     49     19     15     58  
Number of Hours Per Day as Assessed RA-HCRU at Month 12  
[units: hours per day]
Mean ± Standard Deviation
         
Home HC services (n=0,0,0,0,1)     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   1.00  ± NA [2]
Work done (n=60,49,19,15,58)     7.52  ± 2.27     7.82  ± 1.60     9.53  ± 7.65     7.73  ± 2.40     7.93  ± 3.12  
Chores by housekeeper (n=8,4,1,2,10)     4.63  ± 3.16     4.75  ± 0.96     3.00  ± NA [2]   6.00  ± 1.41     4.10  ± 2.08  
Chores by family (n=34,30,8,10,44)     2.65  ± 1.95     4.00  ± 4.11     2.88  ± 2.17     2.70  ± 2.26     2.55  ± 1.81  
Missed work due to RA (n=6,1,0,0,1)     2.00  ± 1.67     4.00  ± NA [2]   NA  ± NA [1]   NA  ± NA [1]   4.00  ± NA [2]
RA related home HC services (n=0,0,0,0,1)     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]