Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00960440
First received: August 14, 2009
Last updated: December 6, 2012
Last verified: December 2012
Results First Received: December 6, 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: Arthritis, Rheumatoid
Interventions: Drug: CP-690,550
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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 up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
STARTED     133     134     66     66  
COMPLETED     107     103     53     48  
NOT COMPLETED     26     31     13     18  
Death                 0                 0                 0                 1  
Adverse Event                 12                 12                 4                 4  
Lack of Efficacy                 2                 5                 3                 8  
Protocol Violation                 2                 8                 3                 4  
Withdrawal by Subject                 9                 5                 2                 1  
Unspecified                 1                 1                 1                 0  



  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 up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
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     Total  
Number of Participants  
[units: participants]
  133     134     66     66     399  
Age  
[units: years]
Mean ± Standard Deviation
  55.4  ± 11.5     55.1  ± 11.3     54.3  ± 11.7     54.5  ± 11.0     55.0  ± 11.3  
Gender  
[units: participants]
         
Female     113     116     53     53     335  
Male     20     18     13     13     64  



  Outcome Measures
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
Measure Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints 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 3 analysis.
Time Frame 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 treatment, had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using Non-Responder Imputation(NRI). 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  132     133     131  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3  
[units: percentage of participants]
  41.67     48.12     24.43  


Statistical Analysis 1 for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
Groups [1] CP-690,550 10 mg vs. Placebo
Method [2] Normal Approximation
P Value [3] <0.0001
Percentage Difference [4] 23.69
Standard Error of the mean ± 5.73
95% Confidence Interval ( 12.45 to 34.92 )
[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 3
Groups [1] CP-690,550 5 mg vs. Placebo
Method [2] Normal Approximation
P Value [3] 0.0024
Percentage Difference [4] 17.23
Standard Error of the mean ± 5.70
95% Confidence Interval ( 6.06 to 28.41 )
[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.



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

Measure Type Primary
Measure Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score 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.
FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  132     134     132  
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3  
[units: Units on a scale]
Mean ± Standard Deviation
     
Baseline (n=132,134,132)     1.60  ± 0.66     1.50  ± 0.61     1.63  ± 0.66  
Change at Month 3 (n=117,125,118)     -0.41  ± 0.52     -0.41  ± 0.52     -0.17  ± 0.41  


Statistical Analysis 1 for Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score 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] -0.28
Standard Error of the mean ± 0.05
95% Confidence Interval ( -0.38 to -0.17 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a 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 Health Assessment Questionnaire-Disability Index (HAQ-DI) Score 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] -0.25
Standard Error of the mean ± 0.05
95% Confidence Interval ( -0.36 to -0.15 )
[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, treatment by visit interaction, and geographic region as fixed effects and participants as a 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.



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

Measure Type Primary
Measure Title Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
Measure Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time Frame 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.
FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  119     125     120  
Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3  
[units: percentage of participants]
  6.72     11.20     1.67  


Statistical Analysis 1 for Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
Groups [1] CP-690,550 10 mg vs. Placebo
Method [2] Normal Approximation
P Value [3] 0.0017
Percentage Difference [4] 9.53
Standard Error of the mean ± 3.05
95% Confidence Interval ( 3.54 to 15.51 )
[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% 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 the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in HAQ-DI had to be statistically significant.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
Groups [1] CP-690,550 5 mg vs. Placebo
Method [2] Normal Approximation
P Value [3] 0.0496
Percentage Difference [4] 5.05
Standard Error of the mean ± 2.57
95% Confidence Interval ( 0.00 to 10.10 )
[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.



4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1   [ Time Frame: Week 2, Month 1 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1
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 Week 2, Month 1  
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  132     133     131  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1  
[units: percentage of participants]
     
Week 2     27.69     32.81     16.67  
Month 1     42.42     44.36     27.48  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1



5.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6   [ Time Frame: Month 4.5, 6 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6
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 4.5, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  132     133     66     65  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6  
[units: percentage of participants]
       
Month 4.5     54.55     47.37     50.00     46.15  
Month 6     51.52     54.89     45.45     40.00  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6



6.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3   [ Time Frame: Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
Measure Description ACR50 response: >= 50% improvement in TJC or SJC 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 Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  132     133     131  
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3  
[units: percentage of participants]
     
Week 2     7.69     5.47     1.59  
Month 1     12.88     17.29     6.11  
Month 3     26.52     27.82     8.40  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3



7.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6   [ Time Frame: Month 4.5 and 6 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6
Measure Description ACR50 response: >= 50% improvement in TJC or SJC 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 4.5 and 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  132     133     66     65  
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6  
[units: percentage of participants]
       
Month 4.5     28.79     28.57     30.30     20.00  
Month 6     37.12     30.08     28.79     20.00  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6



8.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3   [ Time Frame: Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
Measure Description ACR70 response: >=70% improvement in TJC or SJC 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 Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  132     133     131  
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3  
[units: percentage of participants]
     
Week 2     2.31     2.34     0.00  
Month 1     7.58     6.77     0.00  
Month 3     13.64     10.53     1.53  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3



9.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6   [ Time Frame: Month 4.5, 6 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6
Measure Description ACR70 response: >=70% improvement in TJC or SJC 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 4.5, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  132     133     66     65  
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6  
[units: percentage of participants]
       
Month 4.5     10.61     12.78     12.12     7.69  
Month 6     15.91     15.79     10.61     9.23  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6



10.  Secondary:   Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3   [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
Measure Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame Baseline, Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  133     134     132  
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=133,134,132)     5.38  ± 1.00     5.31  ± 0.90     5.39  ± 0.95  
Week 2 (n=127,125,124)     4.46  ± 1.23     4.13  ± 1.04     5.10  ± 1.13  
Month 1 (n=123,123,123)     4.14  ± 1.27     3.92  ± 1.19     4.92  ± 1.20  
Month 3 (n=118,124,118)     3.74  ± 1.31     3.45  ± 1.32     4.78  ± 1.34  

No statistical analysis provided for Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3



11.  Secondary:   Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6   [ Time Frame: Month 4.5, 6 ]

Measure Type Secondary
Measure Title Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6
Measure Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame Month 4.5, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  112     113     56     51  
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 4.5 (n=112,113,56,51)     3.43  ± 1.25     3.30  ± 1.37     3.57  ± 1.15     3.69  ± 1.15  
Month 6 (n=100,102,51,48)     3.36  ± 1.24     3.07  ± 1.18     3.46  ± 1.13     3.68  ± 1.19  

No statistical analysis provided for Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6



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

Measure Type Secondary
Measure Title Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
Measure Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
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.
FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  126     128     130  
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=126,128,130)     6.48  ± 1.03     6.40  ± 0.89     6.47  ± 0.98  
Month 3 (n=112,121,110)     4.58  ± 1.39     4.26  ± 1.48     5.56  ± 1.45  

No statistical analysis provided for Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3



13.  Secondary:   Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
Measure Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  100     100     49     47  
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
  3.99  ± 1.41     3.70  ± 1.25     4.07  ± 1.26     4.39  ± 1.27  

No statistical analysis provided for Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6



14.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3   [ Time Frame: Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 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.
Time Frame Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  130     128     125  
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Week 2 (n=130,128,125)     1.38  ± 0.71     1.28  ± 0.58     1.49  ± 0.63  
Month 1 (n=123,123,123)     1.37  ± 0.68     1.19  ± 0.65     1.38  ± 0.72  
Month 3 (n=118,125,118)     1.20  ± 0.72     1.10  ± 0.66     1.44  ± 0.72  

No statistical analysis provided for Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3



15.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6   [ Time Frame: Month 4.5, 6 ]

Measure Type Secondary
Measure Title Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 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 4.5, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  112     114     57     53  
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 4.5 (n=112,114,57,53)     1.19  ± 0.69     1.10  ± 0.70     1.08  ± 0.60     1.26  ± 0.75  
Month 6 (n=104,103,51,49)     1.10  ± 0.70     1.02  ± 0.65     1.00  ± 0.59     1.29  ± 0.72  

No statistical analysis provided for Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6



16.  Secondary:   Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3   [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Measure Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  130     128     131  
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=127,128,131)     65.73  ± 22.79     60.10  ± 23.16     60.74  ± 23.50  
Week 2 (n=130,128,125)     49.79  ± 26.60     42.35  ± 22.11     55.88  ± 23.85  
Month 1 (n=124,122,123)     45.59  ± 26.02     39.09  ± 24.05     52.29  ± 25.65  
Month 3 (n=119,124,116)     38.91  ± 27.11     37.72  ± 26.99     53.40  ± 26.52  

No statistical analysis provided for Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3



17.  Secondary:   Patient Assessment of Arthritis Pain at Month 4.5 and 6   [ Time Frame: Month 4.5, 6 ]

Measure Type Secondary
Measure Title Patient Assessment of Arthritis Pain at Month 4.5 and 6
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 4.5, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  112     115     56     53  
Patient Assessment of Arthritis Pain at Month 4.5 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 4.5 (n=112,115,56,53)     38.93  ± 26.40     35.01  ± 24.60     33.11  ± 23.44     40.62  ± 26.67  
Month 6 (n=104,103,51,49)     34.38  ± 25.33     29.56  ± 22.77     31.37  ± 24.76     40.71  ± 25.88  

No statistical analysis provided for Patient Assessment of Arthritis Pain at Month 4.5 and 6



18.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3   [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
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, Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  130     128     131  
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=127,128,131)     64.69  ± 23.22     58.79  ± 23.59     61.87  ± 22.92  
Week 2 (n=130,128,124)     48.24  ± 25.54     41.75  ± 21.79     57.70  ± 23.77  
Month 1 (n=124,123,123)     44.86  ± 25.62     38.35  ± 23.38     51.39  ± 26.01  
Month 3 (n=119,125,118)     41.23  ± 27.06     37.23  ± 25.65     52.85  ± 25.64  

No statistical analysis provided for Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3



19.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6   [ Time Frame: Month 4.5, 6 ]

Measure Type Secondary
Measure Title Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 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 Month 4.5, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  112     115     56     53  
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 4.5 (n=112,115,56,53)     37.40  ± 24.65     36.01  ± 25.46     34.38  ± 23.47     38.79  ± 26.17  
Month 6 (n=104,103,51,49)     34.59  ± 24.82     31.25  ± 23.25     34.88  ± 23.84     38.61  ± 22.27  

No statistical analysis provided for Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6



20.  Secondary:   Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3   [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
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, Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  129     128     131  
Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=126,128,131)     65.38  ± 18.21     58.68  ± 19.42     64.36  ± 16.70  
Week 2 (n=129,128,123)     46.51  ± 23.38     41.29  ± 20.58     51.36  ± 21.87  
Month 1 (n=123,122,123)     39.88  ± 22.19     36.28  ± 21.52     47.67  ± 20.84  
Month 3 (n=117,124,116)     34.94  ± 25.22     30.64  ± 22.20     44.08  ± 23.53  

No statistical analysis provided for Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3



21.  Secondary:   Physician Global Assessment of Arthritis at Month 4.5 and 6   [ Time Frame: Month 4.5, 6 ]

Measure Type Secondary
Measure Title Physician Global Assessment of Arthritis at Month 4.5 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 Month 4.5, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  110     114     55     53  
Physician Global Assessment of Arthritis at Month 4.5 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 4.5 (n=110,114,55,53)     27.50  ± 18.87     26.12  ± 22.28     28.67  ± 19.77     28.17  ± 21.50  
Month 6 (n=101,101,51,48)     24.17  ± 18.55     19.65  ± 17.15     23.55  ± 18.30     23.75  ± 16.20  

No statistical analysis provided for Physician Global Assessment of Arthritis at Month 4.5 and 6



22.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3   [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Measure Description SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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).
Time Frame Baseline, Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  133     134     132  
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline:Physical Functioning (n=133,134,132)     30.54  ± 10.76     31.61  ± 8.58     28.32  ± 9.30  
Baseline:Role Physical (n=133,134,132)     33.66  ± 10.21     34.08  ± 9.67     32.53  ± 9.66  
Baseline:Bodily Pain (n=133,134,132)     31.09  ± 8.13     32.55  ± 7.45     31.95  ± 7.70  
Baseline:General Health (n=133,134,132)     35.84  ± 9.50     37.73  ± 9.18     34.82  ± 8.67  
Baseline:Vitality (n=133,134,132)     39.71  ± 9.87     40.11  ± 10.26     38.41  ± 10.77  
Baseline:Social Functioning (n=133,134,132)     37.40  ± 13.10     39.47  ± 12.11     35.95  ± 12.39  
Baseline:Role Emotional (n=133,134,132)     37.58  ± 14.08     36.75  ± 13.58     35.52  ± 14.22  
Baseline:Mental Health (n=133,134,132)     40.66  ± 11.63     41.91  ± 11.99     39.69  ± 12.66  
Baseline:Physical Component Score(n=133,134,132)     30.72  ± 9.29     32.13  ± 7.58     29.98  ± 7.99  
Baseline: Mental Component Score (n=133,134,132)     42.82  ± 12.69     43.24  ± 12.81     41.34  ± 13.25  
Week 2:Physical Functioning (n=130,128,125)     33.28  ± 11.06     34.25  ± 9.30     30.25  ± 10.30  
Week 2:Role Physical (n=130,128,125)     36.71  ± 10.23     38.45  ± 9.04     36.05  ± 10.48  
Week 2:Bodily Pain (n=130,128,125)     37.01  ± 9.34     38.42  ± 7.70     33.77  ± 7.80  
Week 2:General Health (n=130,128,125)     37.38  ± 8.52     38.57  ± 8.61     35.85  ± 8.76  
Week 2:Vitality (n=130,128,125)     43.02  ± 10.18     43.89  ± 10.71     41.11  ± 10.62  
Week 2:Social Functioning (n=130,128,125)     41.18  ± 12.79     42.29  ± 11.29     38.08  ± 12.18  
Week 2:Role Emotional (n=130,128,125)     40.54  ± 12.94     40.62  ± 11.99     37.69  ± 13.49  
Week 2:Mental Health (n=130,128,125)     43.72  ± 11.48     44.25  ± 11.19     42.07  ± 12.31  
Week 2:Physical Component Score (n=130,128,125)     34.04  ± 9.51     35.69  ± 7.74     31.99  ± 8.58  
Week 2:Mental Component Score (n=130,128,125)     45.77  ± 11.93     45.98  ± 11.95     43.57  ± 12.74  
Month 1:Physical Functioning (n=124,123,123)     33.56  ± 11.14     35.64  ± 10.06     31.01  ± 10.15  
Month 1: Role Physical (n=124,123,123)     38.25  ± 10.06     39.59  ± 9.98     36.33  ± 10.56  
Month 1:Bodily Pain(n=124,123,123)     37.50  ± 9.45     40.02  ± 8.42     35.35  ± 8.77  
Month 1:General Health (n=124,123,123)     38.09  ± 9.32     39.82  ± 9.25     36.64  ± 8.75  
Month 1:Vitality (n=124,123,123)     44.33  ± 9.35     45.65  ± 11.47     41.85  ± 11.50  
Month 1:Social Functioning (n=124,123,123)     40.96  ± 11.62     44.12  ± 11.65     39.00  ± 12.49  
Month 1:Role Emotional (n=124,123,123)     41.05  ± 13.23     40.84  ± 12.86     38.87  ± 12.84  
Month 1:Mental Health (n=124,123,123)     44.13  ± 11.68     46.18  ± 11.64     42.89  ± 11.92  
Month 1:Physical Component Score (n=124,123,123)     34.88  ± 9.24     37.07  ± 8.40     32.72  ± 9.18  
Month 1:Mental Component Score (n=124,123,123)     46.13  ± 11.94     47.28  ± 12.47     44.53  ± 12.42  
Month 3:Physical Functioning (n=118,125,117)     34.78  ± 11.43     36.70  ± 10.56     30.54  ± 10.67  
Month 3: Role Physical (n=118,125,117)     38.40  ± 10.49     40.19  ± 10.95     35.09  ± 10.66  
Month 3:Bodily Pain (n=118,125,117)     39.25  ± 9.78     40.93  ± 9.67     34.26  ± 9.62  
Month 3:General Health (n=118,125,117)     39.22  ± 9.78     40.21  ± 9.46     35.30  ± 9.30  
Month 3:Vitality (n=118,125,117)     45.23  ± 10.89     46.23  ± 11.73     40.30  ± 11.71  
Month 3:Social Functioning (n=118,125,117)     41.91  ± 12.37     44.49  ± 11.21     37.74  ± 12.12  
Month 3:Role Emotional (n=118,125,116)     41.21  ± 12.57     41.84  ± 12.67     36.16  ± 14.50  
Month 3:Mental Health (n=118,125,117)     44.58  ± 11.95     45.83  ± 11.59     40.89  ± 12.46  
Month 3:Physical Component Score (n=118,125,116)     36.18  ± 9.96     38.01  ± 9.35     32.38  ± 9.35  
Month 3:Mental Component Score (n=118,125,116)     46.40  ± 11.87     47.37  ± 12.01     41.91  ± 12.85  

No statistical analysis provided for 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3



23.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title 36-Item Short-Form Health Survey (SF-36) at Month 6
Measure Description SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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).
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  104     103     51     49  
36-Item Short-Form Health Survey (SF-36) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 6:Physical Functioning     35.62  ± 11.63     38.47  ± 10.14     35.00  ± 10.31     33.97  ± 10.58  
Month 6: Role Physical     40.72  ± 9.95     43.51  ± 11.21     39.54  ± 10.55     38.02  ± 9.81  
Month 6:Bodily Pain     41.53  ± 9.61     43.63  ± 9.27     42.40  ± 10.22     39.60  ± 9.01  
Month 6:General Health     39.49  ± 9.54     41.68  ± 10.35     38.95  ± 9.51     37.89  ± 8.45  
Month 6:Vitality     46.49  ± 9.82     47.59  ± 10.93     45.09  ± 12.26     44.26  ± 8.73  
Month 6:Social Functioning     44.05  ± 10.93     44.66  ± 11.92     43.33  ± 12.27     40.38  ± 11.11  
Month 6:Role Emotional     42.36  ± 13.34     45.06  ± 12.27     41.07  ± 13.18     39.53  ± 12.93  
Month 6:Mental Health     45.29  ± 12.12     47.48  ± 11.61     44.85  ± 14.61     46.19  ± 9.65  
Month 6:Physical Component Score     37.78  ± 9.20     40.21  ± 9.24     37.84  ± 9.59     35.43  ± 8.69  
Month 6:Mental Component Score     47.41  ± 12.32     48.83  ± 12.65     46.17  ± 15.06     46.03  ± 11.52  

No statistical analysis provided for 36-Item Short-Form Health Survey (SF-36) at Month 6



24.  Secondary:   Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3   [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Measure Description Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.
Time Frame Baseline, Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  133     133     130  
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline: Sleep Problem Summary (n=133,132,129)     40.55  ± 21.13     39.87  ± 18.03     44.65  ± 20.56  
Baseline: Overall Sleep Problem (n=133,132,129)     43.10  ± 21.00     41.57  ± 17.88     46.08  ± 20.73  
Baseline: Sleep Adequacy (n=133,133,129)     46.39  ± 27.89     43.16  ± 25.89     39.53  ± 27.95  
Baseline: Awakened Short of Breath (n=133,133,130)     16.99  ± 24.56     19.10  ± 24.10     21.54  ± 26.19  
Baseline: Sleep Disturbance (n=133,133,129)     47.43  ± 28.39     43.20  ± 24.83     47.98  ± 27.00  
Baseline: Sleep Quantity (n=132,131,129)     6.47  ± 1.55     6.44  ± 1.35     6.33  ± 1.46  
Baseline: Snoring (n=131,131,127)     42.14  ± 31.89     37.10  ± 33.75     40.00  ± 33.62  
Baseline: Somnolence (n=133,132,129)     36.39  ± 22.47     34.19  ± 22.83     38.55  ± 23.60  
Week 2: Sleep Problem Summary (n=129,127,125)     36.87  ± 20.84     37.03  ± 18.97     40.35  ± 20.10  
Week 2: Overall Sleep Problem (n=129,127,124)     38.04  ± 20.78     37.69  ± 18.83     41.47  ± 20.01  
Week 2: Sleep Adequacy (n=129,127,125)     48.06  ± 28.70     44.17  ± 28.35     42.72  ± 26.77  
Week 2: Awakened Short of Breath (n=129,127,125)     17.83  ± 25.28     17.32  ± 21.58     18.72  ± 25.75  
Week 2: Sleep Disturbance (n=129,127,125)     39.59  ± 28.24     36.41  ± 22.89     42.28  ± 26.45  
Week 2: Sleep Quantity (n=129,127,124)     6.40  ± 1.57     6.68  ± 1.41     6.48  ± 1.75  
Week 2: Snoring (n=128,125,122)     36.25  ± 34.21     35.84  ± 34.48     40.49  ± 32.67  
Week 2: Somnolence (n=129,127,124)     31.78  ± 21.85     32.18  ± 23.47     36.45  ± 23.18  
Month 1: Sleep Problem Summary (n=124,123,123)     36.21  ± 20.69     34.53  ± 20.08     37.37  ± 20.42  
Month 1: Overall Sleep Problem (n=124,123,123)     37.23  ± 20.70     35.40  ± 19.94     38.79  ± 20.58  
Month 1: Sleep Adequacy (n=124,123,123)     49.84  ± 28.31     48.13  ± 29.35     49.11  ± 28.86  
Month 1: Awakened Short of Breath (n=124,123,123)     15.81  ± 21.53     15.45  ± 23.16     19.84  ± 26.30  
Month 1: Sleep Disturbance (n=124,123,123)     39.12  ± 28.16     34.82  ± 25.12     39.64  ± 26.26  
Month 1: Sleep Quantity (n=124,123,123)     6.59  ± 1.34     6.80  ± 1.43     6.43  ± 1.42  
Month 1: Snoring (n=124,122,120)     36.13  ± 33.42     34.10  ± 32.80     41.50  ± 33.12  
Month 1: Somnolence (n=124,123,123)     30.91  ± 22.30     30.84  ± 23.97     34.91  ± 23.67  
Month 3: Sleep Problem Summary (n=117,125,117)     36.81  ± 21.10     35.68  ± 19.36     40.14  ± 20.20  
Month 3: Overall Sleep Problem (n=117,125,117)     37.23  ± 20.72     36.08  ± 19.40     42.00  ± 20.41  
Month 3: Sleep Adequacy (n=118,125,117)     48.64  ± 30.32     48.56  ± 29.04     43.68  ± 27.47  
Month 3: Awakened Short of Breath (n=118,125,117)     18.14  ± 23.68     19.68  ± 24.09     17.95  ± 24.27  
Month 3: Sleep Disturbance (n=118,125,117)     38.44  ± 28.37     34.61  ± 23.21     43.27  ± 26.45  
Month 3: Sleep Quantity (n=117,124,117)     6.58  ± 1.50     6.71  ± 1.42     6.27  ± 1.49  
Month 3: Snoring (n=118,123,117)     36.44  ± 32.83     36.26  ± 32.63     41.37  ± 31.92  
Month 3: Somnolence (n=117,125,117)     30.14  ± 23.53     31.31  ± 23.68     36.47  ± 23.10  

No statistical analysis provided for Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3



25.  Secondary:   Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Measure Description Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  104     102     49     49  
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 6: Sleep Problem Summary     35.32  ± 21.46     32.03  ± 18.42     38.78  ± 20.81     35.35  ± 19.05  
Month 6: Overall Sleep Problem     35.75  ± 20.68     32.92  ± 18.33     39.73  ± 20.85     36.02  ± 18.45  
Month 6: Sleep Adequacy     50.48  ± 30.64     52.75  ± 28.46     43.47  ± 30.99     50.42  ± 26.89  
Month 6: Awakened Short of Breath     16.73  ± 24.15     14.12  ± 22.62     18.37  ± 21.54     17.92  ± 21.13  
Month 6: Sleep Disturbance     36.84  ± 26.19     33.88  ± 23.51     40.92  ± 26.89     35.10  ± 25.26  
Month 6: Sleep Quantity     6.56  ± 1.45     6.93  ± 1.29     6.27  ± 1.29     6.80  ± 1.26  
Month 6: Snoring     34.62  ± 31.80     35.84  ± 31.79     37.96  ± 31.95     38.75  ± 32.59  
Month 6: Somnolence     29.74  ± 22.24     26.14  ± 19.40     30.61  ± 22.56     33.19  ± 20.09  

No statistical analysis provided for Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6



26.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3   [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Measure Type Secondary
Measure Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
Time Frame Baseline, Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  133     134     132  
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3  
[units: participants]
     
Baseline (n= 133, 134, 132)     53     59     48  
Week 2 (n= 130, 128, 126)     52     62     50  
Month 1 (n= 124, 123, 124)     59     58     53  
Month 3 (n= 118, 125, 118)     53     56     47  

No statistical analysis provided for Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3



27.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  104     103     51     49  
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6  
[units: participants]
  50     57     21     24  

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



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

Measure Type Secondary
Measure Title Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
Measure Description FACIT-Fatigue Scale (FS):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-FS 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 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  132     134     129  
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=132,134,129)     27.84  ± 11.12     29.48  ± 11.39     26.98  ± 11.52  
Month 3 (n=118,125,117)     33.30  ± 11.72     33.66  ± 12.27     27.93  ± 12.36  

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



29.  Secondary:   Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
Measure Description FACIT-FS: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-FS 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 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  104     102     51     49  
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
  34.69  ± 10.81     35.98  ± 11.55     33.57  ± 12.21     31.63  ± 10.16  

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



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

Measure Type Secondary
Measure Title Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3
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  
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  131     134     129  
Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=131,134,129)     0.38  ± 0.34     0.47  ± 0.32     0.38  ± 0.33  
Month 1 (n=122,121,120)     0.56  ± 0.28     0.63  ± 0.24     0.49  ± 0.30  
Month 3 (n=117,123,117)     0.55  ± 0.30     0.62  ± 0.25     0.43  ± 0.35  

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



31.  Secondary:   Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 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 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  104     101     51     49  
Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
  0.62  ± 0.28     0.68  ± 0.24     0.60  ± 0.24     0.55  ± 0.29  

No statistical analysis provided for Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6



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

Measure Type Secondary
Measure Title Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Measure Description Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare 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=higher medical cost.
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.
FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  133     134     130  
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline: Seen any doctor (n=133,133,130)     1.11  ± 0.31     1.09  ± 0.29     1.15  ± 0.35  
Baseline: Treated in ER (n=133,134,130)     1.89  ± 0.32     1.96  ± 0.19     1.93  ± 0.25  
Baseline: Admitted for overnight stay (n=16,6,9)     0.19  ± 0.54     0.17  ± 0.41     0.33  ± 0.71  
Baseline: Hospitalization (n=133,134,130)     1.97  ± 0.17     1.97  ± 0.17     1.95  ± 0.23  
Baseline: Had outpatient surgeries (n=133,134,130)     1.95  ± 0.21     1.97  ± 0.17     1.93  ± 0.25  
Baseline:Non-study diagnostic tests(n=133,134,130)     1.74  ± 0.44     1.75  ± 0.43     1.74  ± 0.44  
Baseline: In nursing home (n=133,134,130)     1.99  ± 0.09     1.99  ± 0.09     1.99  ± 0.09  
Baseline: Home HC services (n=133,134,130)     1.98  ± 0.12     1.99  ± 0.09     1.96  ± 0.19  
Baseline: Home healthcare services (n=2,2,5)     1.50  ± 0.71     0.50  ± 0.71     0.80  ± 0.84  
Baseline:Required aids/devices (n=133,134,130)     1.77  ± 0.42     1.86  ± 0.35     1.82  ± 0.39  
Baseline: Seen NM practitioner (n=133,134,130)     1.97  ± 0.17     1.96  ± 0.21     1.96  ± 0.19  
Baseline: Currently employed (n=132,134,130)     1.70  ± 0.46     1.66  ± 0.48     1.68  ± 0.47  
Baseline: Feel well enough to work (n=84,78,83)     1.85  ± 0.36     1.82  ± 0.39     1.82  ± 0.39  
Baseline: Retired (n=85,80,86)     1.49  ± 0.50     1.43  ± 0.50     1.49  ± 0.50  
Baseline: Lost job/retired early (n=83,77,80)     1.58  ± 0.50     1.69  ± 0.47     1.55  ± 0.50  
Baseline: Unable to work due to RA (n=84,77,83)     1.36  ± 0.48     1.48  ± 0.50     1.40  ± 0.49  
Baseline: Work disabled due to RA (n=83,77,79)     1.46  ± 0.50     1.55  ± 0.50     1.48  ± 0.50  
Baseline: Sick leave due to RA (n=104,109,100)     1.83  ± 0.38     1.80  ± 0.40     1.71  ± 0.46  
Baseline: Performed part time work (n=103,108,100)     1.94  ± 0.24     1.94  ± 0.25     1.88  ± 0.33  
Baseline: Performed paid work (n=102,109,98)     1.65  ± 0.48     1.63  ± 0.48     1.65  ± 0.48  
Baseline: Unable to do chores (n=130,130,126)     1.37  ± 0.48     1.42  ± 0.49     1.27  ± 0.45  
Baseline: Chores by housekeeper (n=130,134,130)     1.85  ± 0.36     1.86  ± 0.35     1.82  ± 0.39  
Baseline: Chores by family/friends (n=131,134,130)     1.44  ± 0.50     1.49  ± 0.50     1.48  ± 0.50  
Month 3: Seen any doctor (n=117,125,117)     1.23  ± 0.42     1.21  ± 0.41     1.21  ± 0.41  
Month 3: Treated in ER (n=116,125,117)     1.94  ± 0.24     1.94  ± 0.25     1.93  ± 0.25  
Month 3: Admitted for overnight stay (n=7,8,8)     0.29  ± 0.76     0.00  ± 0.00     0.13  ± 0.35  
Month 3: Hospitalization (n=116,124,117)     1.99  ± 0.09     2.00  ± 0.00     1.98  ± 0.13  
Month 3: Had outpatient surgeries (n=116,125,117)     1.94  ± 0.24     1.98  ± 0.15     1.97  ± 0.18  
Month 3:Non study diagnostic tests (n=116,125,117)     1.80  ± 0.40     1.82  ± 0.38     1.77  ± 0.42  
Month 3: In nursing home (n=116,125,117)     1.99  ± 0.09     1.99  ± 0.09     1.99  ± 0.09  
Month 3: Home HC services (n=116,123,117)     1.97  ± 0.16     1.99  ± 0.09     1.97  ± 0.16  
Month 3: Required aids/devices (n=116,125,117)     1.81  ± 0.39     1.91  ± 0.28     1.76  ± 0.43  
Month 3: Seen NM practitioner (n=116,125,117)     1.97  ± 0.18     1.97  ± 0.18     1.97  ± 0.18  
Month 3: Currently employed (n=115,125,117)     1.70  ± 0.46     1.62  ± 0.49     1.68  ± 0.47  
Month 3: Feel well enough to work (n=68,67,70)     1.82  ± 0.38     1.78  ± 0.42     1.83  ± 0.38  
Month 3: Retired (n=68,66,72)     1.56  ± 0.50     1.36  ± 0.48     1.53  ± 0.50  
Month 3: Lost job/retired early (n=67,68,69)     1.70  ± 0.46     1.69  ± 0.47     1.59  ± 0.49  
Month 3: Unable to work due to RA (n=68,66,71)     1.41  ± 0.50     1.53  ± 0.50     1.44  ± 0.50  
Month 3: Work disabled due to RA (n=67,67,69)     1.48  ± 0.50     1.57  ± 0.50     1.54  ± 0.50  
Month 3: Sick leave due to RA (n=95,100,97)     1.88  ± 0.32     1.86  ± 0.35     1.82  ± 0.38  
Month 3: Performed part time work (n=96,100,96)     1.96  ± 0.20     1.94  ± 0.24     1.94  ± 0.24  
Month 3: Performed paid work (n=96,99,97)     1.78  ± 0.42     1.69  ± 0.47     1.67  ± 0.47  
Month 3: Unable to do chores (n=112,120,113)     1.57  ± 0.50     1.63  ± 0.49     1.45  ± 0.50  
Month 3: Chores by housekeeper (n=116,122,117)     1.86  ± 0.35     1.89  ± 0.32     1.85  ± 0.35  
Month 3: Chores by family/friends (n=116,122,116)     1.55  ± 0.50     1.66  ± 0.48     1.53  ± 0.50  

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



33.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Measure Description RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare 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=higher medical cost.
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  103     102     50     49  
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 6: Seen any doctor (n=102,101,50,49)     1.29  ± 0.46     1.22  ± 0.41     1.20  ± 0.40     1.27  ± 0.45  
Month 6: Treated in ER (n=103,102,50,49)     1.96  ± 0.19     1.93  ± 0.25     1.94  ± 0.24     1.98  ± 0.14  
Month 6: Admitted for overnight stay (n=5,7,3,1)     0.20  ± 0.45     0.00  ± 0.00     1.33  ± 1.15     0.00  ± NA [1]
Month 6: Hospitalization (n=102,102,50,49)     1.98  ± 0.14     1.99  ± 0.10     1.96  ± 0.20     1.98  ± 0.14  
Month 6:Had outpatient surgeries (n=103,102,50,49)     2.00  ± 0.00     1.95  ± 0.22     1.96  ± 0.20     1.96  ± 0.20  
Month 6:Non-study diagnostic test(n=103,102,50,49)     1.85  ± 0.35     1.84  ± 0.37     1.74  ± 0.44     1.86  ± 0.35  
Month 6: In nursing home (n=103,102,50,49)     1.98  ± 0.14     2.00  ± 0.00     2.00  ± 0.00     1.96  ± 0.20  
Month 6: Home HC services (n=101,102,50,49)     2.00  ± 0.00     1.98  ± 0.14     2.00  ± 0.00     2.00  ± 0.00  
Month 6: Required aids/devices (n=103,102,50,48)     1.82  ± 0.39     1.91  ± 0.29     1.90  ± 0.30     1.83  ± 0.38  
Month 6: Seen NM practitioner (n=103,102,50,49)     1.99  ± 0.10     1.96  ± 0.20     1.98  ± 0.14     1.96  ± 0.20  
Month 6: Currently employed (n=103,102,50,49)     1.67  ± 0.47     1.63  ± 0.49     1.60  ± 0.49     1.71  ± 0.46  
Month 6: Feel well enough to work (n=62,57,27,32)     1.81  ± 0.40     1.68  ± 0.47     1.70  ± 0.47     1.88  ± 0.34  
Month 6: Retired (n=62,56,28,31)     1.45  ± 0.50     1.36  ± 0.48     1.43  ± 0.50     1.39  ± 0.50  
Month 6: Lost job/retired early (n=62,54,27,32)     1.71  ± 0.46     1.74  ± 0.44     1.59  ± 0.50     1.44  ± 0.50  
Month 6: Unable to work due to RA (n=62,55,27,32)     1.48  ± 0.50     1.67  ± 0.47     1.56  ± 0.51     1.41  ± 0.50  
Month 6: Work disabled due to RA (n=61,53,27,32)     1.57  ± 0.50     1.70  ± 0.46     1.56  ± 0.51     1.50  ± 0.51  
Month 6: Sick leave due to RA (n=85,84,41,37)     1.92  ± 0.28     1.88  ± 0.33     1.88  ± 0.33     1.86  ± 0.35  
Month 6: Performed part time work (n=85,84,40,36)     1.96  ± 0.19     1.95  ± 0.21     2.00  ± 0.00     1.92  ± 0.28  
Month 6: Performed paid work (n=83,84,40,36)     1.71  ± 0.46     1.75  ± 0.44     1.65  ± 0.48     1.64  ± 0.49  
Month 6: Unable to do chores (n=101,98,49,48)     1.65  ± 0.48     1.73  ± 0.44     1.51  ± 0.51     1.44  ± 0.50  
Month 6: Chores by housekeeper (n=103,99,50,49)     1.92  ± 0.27     1.91  ± 0.29     1.82  ± 0.39     1.90  ± 0.31  
Month 6: Chores by family/friends (n=103,99,50,49)     1.69  ± 0.47     1.77  ± 0.42     1.62  ± 0.49     1.55  ± 0.50  
[1] 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 6



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

Measure Type Secondary
Measure Title Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
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  
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  119     121     111  
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3  
[units: number of events]
Mean ± Standard Deviation
     
Baseline: Doctor visit (n=119,121,111)     5.07  ± 5.00     5.09  ± 5.10     4.58  ± 3.82  
Baseline: NM practitioner visits (n=4,6,5)     5.75  ± 4.35     4.83  ± 3.25     21.40  ± 29.75  
Baseline: Hospital ER visit (n=14,5,9)     1.79  ± 1.53     2.00  ± 1.73     1.22  ± 0.44  
Baseline: Hospitalization (n=4,4,7)     1.25  ± 0.50     1.00  ± 0.00     1.14  ± 0.38  
Baseline: Outpatient surgery (n=6,4,8)     1.17  ± 0.41     1.00  ± 0.00     1.00  ± 0.00  
Baseline: Non-study diagnostic tests (n=34,32,32)     1.85  ± 1.02     2.06  ± 1.72     1.69  ± 0.97  
Baseline: RA related doctor visit (n=117,120,111)     1.46  ± 0.91     1.18  ± 0.84     1.44  ± 0.93  
Baseline: RA related ER visit (n=15,6,9)     0.67  ± 0.90     0.67  ± 0.82     0.89  ± 0.93  
Baseline: RA related diagnostic test (n=35,33,34)     0.71  ± 0.83     0.79  ± 1.14     0.82  ± 0.76  
Baseline: RA related hospitalization (n=4,5,7)     0.75  ± 0.96     0.80  ± 1.10     0.86  ± 0.69  
Baseline: RA related outpatient surgery (n=6,5,9)     0.33  ± 0.82     0.80  ± 0.84     0.89  ± 0.93  
Baselin:RA related NM visit (n=4,7,5)     1.25  ± 0.96     0.57  ± 0.53     1.00  ± 1.00  
Month 3: Doctor visit (n=89,99,93)     3.30  ± 2.91     3.69  ± 3.73     4.04  ± 4.59  
Month 3: NM practitioners visits (n=4,4,4)     36.25  ± 40.25     5.00  ± 2.00     8.75  ± 10.63  
Month 3: Hospital ER visit (n=7,8,8)     1.00  ± 0.00     1.38  ± 1.06     1.38  ± 0.74  
Month 3: Hospitalization (n=1,0,2)     1.00  ± NA [1]   NA  ± NA [2]   1.00  ± 0.00  
Month 3: Outpatient surgery (n=7,3,4)     1.14  ± 0.38     1.00  ± 0.00     1.00  ± 0.00  
Month 3: Non-study diagnostic tests (n=22,22,26)     1.82  ± 1.65     1.14  ± 0.35     1.62  ± 1.27  
Month 3: RA related doctor visit (n=90,98,93)     1.16  ± 1.08     0.82  ± 0.65     1.13  ± 0.92  
Month 3: RA related ER visit (n=7,8,8)     0.43  ± 0.79     0.00  ± 0.00     0.75  ± 1.39  
Month 3: RA related diagnostic test (n=23,22,26)     0.30  ± 0.47     0.23  ± 0.43     0.35  ± 0.56  
Month 3: RA related hospitalization (n=1,0,2)     0.00  ± NA [1]   NA  ± NA [2]   0.00  ± 0.00  
Month 3:RA related outpatient surgery (n=7,3,4)     0.43  ± 0.79     0.67  ± 1.15     1.00  ± 1.15  
Month 3:RA related NM visit (n=4,4,4)     0.75  ± 0.96     1.25  ± 0.96     1.25  ± 0.96  
[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 Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3



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

Measure Type Secondary
Measure Title Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 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 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  73     80     40     36  
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6  
[units: number of events]
Mean ± Standard Deviation
       
Month 6: Doctor visit (n=73,80,39,36)     3.26  ± 2.83     3.84  ± 4.25     3.64  ± 4.03     4.97  ± 6.73  
Month 6: NM practitioner visit (n=1,4,1,2)     5.00  ± NA [1]   15.50  ± 10.63     20.00  ± NA [1]   4.00  ± 0.00  
Month 6: Hospital ER visit (n=4,7,3,1)     1.25  ± 0.50     1.43  ± 0.79     1.67  ± 1.15     1.00  ± NA [1]
Month 6: Hospitalization (n=2,1,2,1)     2.00  ± 0.00     1.00  ± NA [1]   1.00  ± 0.00     1.00  ± NA [1]
Month 6: Outpatient surgery (n=0,5,2,2)     NA  ± NA [2]   1.00  ± 0.00     2.50  ± 0.71     1.50  ± 0.71  
Month 6: Non-study diagnostic test (n=15,16,13,7)     2.07  ± 2.02     1.19  ± 0.54     1.85  ± 0.99     1.14  ± 0.38  
Month 6: RA related doctor visit (n=73,80,40,36)     1.10  ± 0.87     0.86  ± 0.76     0.85  ± 0.83     1.00  ± 0.96  
Month 6: RA related ER visit (n=4,7,3,1)     0.00  ± 0.00     0.00  ± 0.00     0.00  ± 0.00     0.00  ± NA [1]
Month 6: RA related diagnostic test (n=16,16,13,7)     0.44  ± 0.73     0.00  ± 0.00     0.31  ± 0.85     0.29  ± 0.49  
Month 6: RA related hospitalization (n=2,1,2,1)     0.00  ± 0.00     0.00  ± NA [1]   0.00  ± 0.00     2.00  ± NA [1]
Month 6:RA related outpatient surgery (n=5,2,0,2)     0.00  ± 0.00     2.00  ± 0.00     NA  ± NA [2]   0.00  ± 0.00  
Month6:RA related NM practitioner visit(n=1,4,1,2)     1.00  ± NA [1]   2.00  ± 1.63     0.00  ± NA [1]   1.00  ± 1.41  
[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 Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6



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

Measure Type Secondary
Measure Title Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
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 were reported.
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.
FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  71     65     66  
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3  
[units: days]
Mean ± Standard Deviation
     
Baseline: Hospital length of stay (n=4,4,7)     1.75  ± 0.96     7.00  ± 7.57     5.43  ± 3.78  
Baseline: Days in nursing home (n=1,1,1)     2.00  ± NA [1]   28.00  ± NA [1]   28.00  ± NA [1]
Baseline: Days devices/aids used (n=31,18,24)     122.94  ± 139.56     100.28  ± 122.82     94.63  ± 86.62  
Baseline: Days of work per week (n=39,46,41)     4.67  ± 1.24     4.83  ± 1.29     4.90  ± 1.18  
Baseline: Chores by housekeeper (n=20,18,24)     13.35  ± 20.32     20.56  ± 32.53     15.88  ± 23.45  
Baseline: Chores by family/friend (n=71,65,66)     27.55  ± 31.88     26.31  ± 32.27     27.38  ± 30.75  
Baseline: Days on sick leave (n=17,22,28)     19.76  ± 25.59     13.09  ± 16.15     23.71  ± 31.28  
Baseline: Days of part time work (n=6,6,11)     41.33  ± 40.41     6.83  ± 4.96     12.36  ± 16.20  
Baseline: Paid work, bothered by RA (n=36,40,32)     50.72  ± 63.36     39.75  ± 32.85     31.00  ± 30.79  
Baseline: RA related devices/aids used (31,20,24)     2.06  ± 1.59     1.75  ± 1.48     1.79  ± 0.88  
Month 3: Hospital length of stay (n=1,0,2)     12.00  ± NA [1]   NA  ± NA [2]   11.00  ± 12.73  
Month 3: Days in nursing home (n=1,1,1)     9.00  ± NA [1]   21.00  ± NA [1]   21.00  ± NA [1]
Month 3: Days devices/aids used (n=21,10,26)     113.24  ± 102.65     264.10  ± 429.48     73.85  ± 70.60  
Month 3: Days of work per week (n=33,47,37)     4.94  ± 1.09     4.89  ± 1.09     4.65  ± 1.06  
Month 3: Chores by housekeeper (n=15,14,17)     13.00  ± 16.76     16.93  ± 31.22     10.12  ± 12.84  
Month 3: Chores by family/friend (n=50,41,52)     27.30  ± 31.13     24.24  ± 32.54     25.19  ± 36.03  
Month 3: Days on sick leave (n=11,13,16)     22.09  ± 28.51     6.62  ± 4.94     13.69  ± 20.16  
Month 3: Days of part time work (n=4,4,5)     8.25  ± 9.46     9.25  ± 7.89     8.20  ± 11.12  
Month 3: Paid work, bothered by RA (n=19,29,28)     26.58  ± 30.30     17.76  ± 23.98     30.54  ± 30.39  
Month 3: RA related devices/aids used (22,11,27)     2.09  ± 1.31     3.00  ± 4.45     2.04  ± 1.26  
[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 Baseline and Month 3



37.  Secondary:   Number of Days as Assessed Using RA-HCRU at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Number of Days as Assessed Using RA-HCRU at Month 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 were reported.
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  83     84     40     36  
Number of Days as Assessed Using RA-HCRU at Month 6  
[units: days]
Mean ± Standard Deviation
       
Month 6: Hospital length of stay (n=2,1,2,1)     32.00  ± 33.94     3.00  ± NA [1]   25.00  ± 21.21     24.00  ± NA [1]
Month 6: Days in nursing home (n=2,0,0,2)     21.50  ± 0.71     NA  ± NA [2]   NA  ± NA [2]   13.50  ± 2.12  
Month 6: Days devices/aids used (n=18,7,5,8)     141.28  ± 105.31     68.43  ± 30.12     182.40  ± 87.11     75.00  ± 79.33  
Month 6: Days of work per week (n=34,36,20,14)     4.62  ± 1.33     4.97  ± 1.00     4.85  ± 0.99     4.71  ± 1.49  
Month 6: Chores by housekeeper (n=8,9,9,5)     12.75  ± 13.21     24.89  ± 36.09     9.22  ± 10.73     7.80  ± 4.55  
Month 6: Chores by family/friend (n=32,23,18,19)     28.91  ± 32.10     18.83  ± 26.97     19.33  ± 24.14     17.63  ± 26.46  
Month 6: Days on sick leave (n=7,10,5,5)     21.00  ± 31.86     10.40  ± 14.49     9.20  ± 11.17     42.60  ± 44.81  
Month 6: Days of part time work (n=3,3,0,3)     5.67  ± 8.08     9.33  ± 5.03     NA  ± NA [2]   21.33  ± 33.49  
Month 6: Paid work, bothered by RA (n=21,19,12,11)     25.00  ± 32.76     14.95  ± 20.85     22.17  ± 31.98     19.64  ± 21.73  
Month 6: RA related devices/aids used (19,8,5,8)     2.05  ± 1.22     1.13  ± 0.64     2.20  ± 0.84     1.63  ± 1.19  
[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 6



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

Measure Type Secondary
Measure Title Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
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  
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  71     63     66  
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3  
[units: hours per day]
Mean ± Standard Deviation
     
Baseline: Home healthcare services (n=2,1,4)     5.00  ± 4.24     3.00  ± NA [1]   7.25  ± 11.18  
Baseline: Work done (n=39,45,41)     9.41  ± 8.52     8.18  ± 7.18     8.98  ± 7.35  
Baseline: Chores by housekeeper (n=19,18,23)     4.68  ± 3.23     3.83  ± 1.54     4.78  ± 2.37  
Baseline: Chores by family/friend (n=71,63,66)     2.85  ± 1.89     4.44  ± 11.21     3.42  ± 2.61  
Baseline: Missed work due to RA (n=6,6,11)     2.67  ± 1.97     3.17  ± 2.23     7.55  ± 7.31  
Baseline: RA related home HC services (n=2,2,5)     1.50  ± 0.71     0.50  ± 0.71     0.80  ± 0.84  
Month 3: Home healthcare services (n=3,1,3)     4.00  ± 3.46     2.00  ± NA [1]   9.33  ± 12.70  
Month 3: Work done (n=34,46,37)     7.97  ± 4.72     9.20  ± 8.52     7.76  ± 1.98  
Month 3: Chores by housekeeper (n=15,14,17)     4.00  ± 2.20     3.71  ± 1.14     5.41  ± 5.26  
Month 3: Chores by family/friend (n=50,41,49)     3.50  ± 3.72     2.83  ± 2.57     4.00  ± 5.34  
Month 3: Missed work due to RA (n=4,4,5)     3.00  ± 2.00     6.25  ± 6.18     7.80  ± 9.12  
Month 3: RA related home HC services (n=3,1,3)     1.33  ± 0.58     1.00  ± NA [1]   1.67  ± 0.58  
[1] Standard deviation was not estimable since only 1 participant was evaluable.

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



39.  Secondary:   Number of Hours Per Day as Assessed RA-HCRU at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Number of Hours Per Day as Assessed RA-HCRU at Month 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 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  34     36     20     19  
Number of Hours Per Day as Assessed RA-HCRU at Month 6  
[units: hours per day]
Mean ± Standard Deviation
       
Month 6: Home healthcare services (n=0,2,0,0)     NA  ± NA [1]   2.00  ± 1.41     NA  ± NA [1]   NA  ± NA [1]
Month 6: Work done (n=34,36,20,14)     7.53  ± 2.19     10.36  ± 9.85     7.65  ± 2.16     10.21  ± 8.78  
Month 6: Chores by housekeeper (n=8,9,9,5)     2.88  ± 2.36     3.78  ± 1.20     5.00  ± 3.28     5.00  ± 1.58  
Month 6: Chores by family/friend (n=31,22,18,19)     3.16  ± 2.57     2.05  ± 1.05     2.72  ± 1.67     3.63  ± 5.58  
Month 6: Missed work due to RA (n=3,3,0,3)     4.00  ± 0.00     2.67  ± 1.15     NA  ± NA [1]   2.00  ± 1.73  
Month 6: RA related home HC services (n=0,2,0,0)     NA  ± NA [1]   1.00  ± 0.00     NA  ± NA [1]   NA  ± NA [1]
[1] 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 Month 6



40.  Secondary:   Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

Measure Type Secondary
Measure Title Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Measure Description Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
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.
FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  73     76     73  
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=73,76,72)     4.27  ± 3.20     4.38  ± 3.12     4.65  ± 3.23  
Month 3 (n=63,72,73)     3.52  ± 3.24     3.51  ± 4.73     4.04  ± 3.37  

No statistical analysis provided for Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3



41.  Secondary:   Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
Measure Description Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  59     63     33     29  
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
  3.27  ± 2.94     2.63  ± 2.75     3.33  ± 3.22     4.83  ± 3.33  

No statistical analysis provided for Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6



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

Measure Type Secondary
Measure Title Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
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: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). 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 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  44     57     57  
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline: TMS (n=42,54,48)     43.96  ± 26.39     48.53  ± 25.03     50.91  ± 28.08  
Baseline: PDS (n=43,55,55)     49.44  ± 28.49     48.95  ± 21.50     51.86  ± 25.25  
Baseline: MIDS (n=42,54,56)     28.44  ± 24.35     31.79  ± 23.66     34.36  ± 27.68  
Baseline: ODS (n=41,50,52)     41.95  ± 31.50     37.30  ± 25.74     40.20  ± 25.89  
Baseline: WLI (n=44,57,57)     10.51  ± 6.07     10.27  ± 5.71     10.99  ± 5.96  
Month 3: TMS (n=38,50,42)     36.09  ± 26.83     36.47  ± 26.72     47.62  ± 29.23  
Month 3: PDS (n=40,51,43)     52.08  ± 30.74     47.20  ± 26.39     42.31  ± 24.32  
Month 3: MIDS (n=40,54,44)     27.82  ± 28.80     28.60  ± 27.34     37.22  ± 28.70  
Month 3: ODS (n=39,51,43)     26.30  ± 29.16     30.78  ± 26.12     42.67  ± 28.97  
Month 3: WLI (n=43,56,44)     8.30  ± 6.57     8.73  ± 6.11     11.67  ± 6.29  

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



43.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Work Limitations Questionnaire (WLQ) Score at Month 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: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). 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 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  40     45     24     19  
Work Limitations Questionnaire (WLQ) Score at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 6: TMS (n=39,42,23,18)     26.96  ± 29.72     30.77  ± 27.83     32.50  ± 30.79     32.73  ± 25.10  
Month 6: PDS (n=38,42,24,18)     47.53  ± 36.97     44.65  ± 30.60     40.94  ± 27.82     47.15  ± 29.47  
Month 6: MIDS (n=40,45,24,19)     18.50  ± 26.90     29.84  ± 29.03     31.95  ± 32.26     30.68  ± 32.09  
Month 6: ODS (n=39,44,24,19)     21.32  ± 27.74     29.20  ± 29.00     30.50  ± 31.94     33.68  ± 28.02  
Month 6: WLI (n=40,45,24,19)     6.87  ± 6.53     8.78  ± 7.07     9.27  ± 7.06     9.62  ± 7.41  

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



44.  Other Pre-specified:   Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3   [ Time Frame: Week 2, Month 1, 3 ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
Measure Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame Week 2, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  132     133     131  
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3  
[units: participants]
     
Week 2: DAS28-3(CRP) <2.6 (n=127,125,124)     8     12     2  
Week 2: DAS28-3(CRP) <=3.2 (n=127,125,124)     19     23     4  
Month 1: DAS28-3(CRP) <2.6 (n=132,133,131)     14     7     3  
Month 1: DAS28-3(CRP) <=3.2 (n=132,133,131)     27     42     11  
Month 3: DAS28-3(CRP) <2.6 (n=132,133,131)     27     35     6  
Month 3: DAS28-3(CRP) <=3.2 (n=132,133,131)     45     57     13  

No statistical analysis provided for Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3



45.  Other Pre-specified:   Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6   [ Time Frame: Month 4.5, 6 ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6
Measure Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame Month 4.5, 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  132     133     66     65  
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6  
[units: participants]
       
Month 4.5: DAS28-3(CRP) <2.6     31     42     14     12  
Month 4.5: DAS28-3(CRP) <=3.2     50     57     21     19  
Month 6: DAS28-3(CRP) <2.6     35     36     11     9  
Month 6: DAS28-3(CRP) <=3.2     57     59     23     19  

No statistical analysis provided for Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6



46.  Other Pre-specified:   Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3   [ Time Frame: Month 3 ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3
Measure Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Time Frame 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.
FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  119     125     120  
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3  
[units: participants]
     
Month 3: DAS28-4 (ESR) <2.6     8     14     2  
Month 3: DAS28-4 (ESR) <=3.2     17     28     6  

No statistical analysis provided for Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3



47.  Other Pre-specified:   Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6   [ Time Frame: Month 6 ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6
Measure Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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  
Number of Participants Analyzed  
[units: participants]
  122     127     63     60  
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6  
[units: participants]
       
Month 6: DAS28-4(ESR) <2.6     13     20     7     2  
Month 6: DAS28-4 (ESR) <=3.2     35     37     11     11  

No statistical analysis provided for Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6




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