A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00814307
First received: December 22, 2008
Last updated: January 10, 2013
Last verified: January 2013
Results First Received: December 5, 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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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     244     245     61     61  
Treated     243     245     61     61  
COMPLETED     232     218     54     51  
NOT COMPLETED     12     27     7     10  
Randomized but not treated                 1                 0                 0                 0  
Adverse Event                 3                 9                 3                 2  
Lack of Efficacy                 1                 1                 3                 4  
Unspecified                 1                 2                 0                 1  
Protocol Violation                 2                 8                 1                 1  
Withdrawal by Subject                 4                 6                 0                 2  
Death                 0                 1                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
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]
  243     245     61     61     610  
Age  
[units: Years]
Mean ± Standard Deviation
  52.2  ± 11.5     52.4  ± 11.7     50.7  ± 12.8     48.8  ± 11.9     51.8  ± 11.8  
Gender  
[units: Participants]
         
Female     207     216     54     51     528  
Male     36     29     7     10     82  



  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 joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
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 drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed)=participants evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  241     242     120  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3  
[units: percentage of participants]
  59.75     65.70     26.67  


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
Percent difference [4] 39.04
95% Confidence Interval ( 29.12 to 48.95 )
[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 each dose of CP-690,550 to placebo.
[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] <0.0001
Percent difference [4] 33.08
95% Confidence Interval ( 23.04 to 43.13 )
[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 each dose of CP-690,550 to placebo.
[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 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at given time points for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  240     241     122  
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=240,241,122)     1.53  ± 0.66     1.50  ± 0.64     1.53  ± 0.65  
Change at Month 3 (n=237,227,109)     -0.48  ± 0.66     -0.54  ± 0.60     -0.18  ± 0.61  


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] Linear mixed effect model
P Value [3] <.0001
Least squares mean difference [4] -0.38
95% Confidence Interval ( -0.50 to -0.27 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, 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] Linear mixed effect model
P Value [3] <0.0001
Least squares mean difference [4] -0.31
95% Confidence Interval ( -0.43 to -0.20 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and 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 Participant With Disease Activity Score Using 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 Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
Measure Description DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 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: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  229     219     104  
Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3  
[units: percentage of participants]
  6.11     10.05     4.81  


Statistical Analysis 1 for Percentage of Participant With Disease Activity Score Using 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] 0.0728
Percent difference [4] 5.24
95% Confidence Interval ( -0.49 to 10.96 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participant With Disease Activity Score Using 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] 0.6193
Percent difference [4] 1.31
95% Confidence Interval ( -3.85 to 6.46 )
[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 each dose of CP-690550 to placebo.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and 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, Month 1 and 2   [ Time Frame: Week 2, Month 1, 2 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2
Measure Description ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Week 2, Month 1, 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  241     242     120  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2  
[units: percentage of participants]
     
Week 2     29.58     39.17     11.76  
Month 1     46.47     52.07     21.67  
Month 2     56.85     60.74     25.83  

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



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 tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Month 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: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  241     242     60     60  
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6  
[units: percentage of participants]
       
Month 4     69.29     69.01     51.67     61.67  
Month 5     68.46     69.83     61.67     63.33  
Month 6     69.29     71.07     58.33     56.67  

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, 2 and 3   [ Time Frame: Week 2, Month 1, 2, 3 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3
Measure Description ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time Frame Week 2, Month 1, 2, 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  241     242     120  
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3  
[units: percentage of participants]
     
Week 2     5.83     12.92     4.20  
Month 1     17.43     23.97     4.17  
Month 2     26.14     33.88     5.83  
Month 3     31.12     36.78     12.50  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 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, 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: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of 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: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  241     242     60     60  
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6  
[units: percentage of participants]
       
Month 4     37.34     42.98     28.33     28.33  
Month 5     39.42     45.45     36.67     35.00  
Month 6     41.91     46.69     33.33     33.33  

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, 2 and 3   [ Time Frame: Week 2, Month 1, 2, 3 ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3
Measure Description ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time Frame Week 2, Month 1, 2, 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  241     242     120  
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3  
[units: percentage of participants]
     
Week 2     2.08     4.58     0.00  
Month 1     4.98     9.09     1.67  
Month 2     9.96     19.01     3.33  
Month 3     15.35     20.25     5.83  

No statistical analysis provided for Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 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 tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of 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: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  241     242     60     60  
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6  
[units: percentage of participants]
       
Month 4     19.92     26.03     13.33     15.00  
Month 5     21.16     28.51     18.33     18.33  
Month 6     21.99     29.34     20.00     21.67  

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 Using 28-Joint 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 Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
Measure Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 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 population. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  236     234     115  
Disease Activity Score Using 28-Joint 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= 236, 234, 115)     6.71  ± 0.93     6.70  ± 0.94     6.65  ± 0.93  
Month 3 (n= 229, 219, 104)     4.78  ± 1.37     4.55  ± 1.39     5.54  ± 1.46  

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



11.  Secondary:   Disease Activity Score Using 28-Joint 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 Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
Measure Description DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 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: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  221     209     52     47  
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
  4.33  ± 1.39     4.01  ± 1.38     4.31  ± 1.34     3.98  ± 1.50  

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



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

Measure Type Secondary
Measure Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3
Measure Description DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Week 2, Month 1, 2, 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 population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  239     242     121  
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n= 239, 242, 121)     5.68  ± 0.90     5.60  ± 0.91     5.56  ± 0.85  
Week 2 (n= 234, 231, 118)     4.79  ± 1.12     4.42  ± 1.11     5.30  ± 1.13  
Month 1 (n= 237, 236, 115)     4.41  ± 1.12     3.99  ± 1.26     4.98  ± 1.25  
Month 2 (n= 238, 233, 109)     4.02  ± 1.26     3.64  ± 1.27     4.85  ± 1.36  
Month 3 (n= 238, 229, 109)     3.89  ± 1.27     3.59  ± 1.27     4.68  ± 1.27  

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



13.  Secondary:   Disease Activity Score Using 28-Joint 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 Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6
Measure Description DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Month 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 population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  235     222     55     50  
Disease Activity Score Using 28-Joint 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 (n= 235, 222, 54, 48)     3.65  ± 1.24     3.26  ± 1.22     3.89  ± 1.19     3.50  ± 1.28  
Month 5 (n= 231, 219, 55, 50)     3.54  ± 1.26     3.12  ± 1.24     3.53  ± 1.25     3.34  ± 1.26  
Month 6 (n= 228, 215, 53, 50)     3.48  ± 1.23     3.11  ± 1.26     3.56  ± 1.32     3.12  ± 1.34  

No statistical analysis provided for Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6



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

Measure Type Secondary
Measure Title Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
Measure Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Time Frame Baseline, Week 2, Month 1, 2, 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 population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  240     241     122  
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n= 240, 241, 122)     1.53  ± 0.66     1.50  ± 0.64     1.53  ± 0.65  
Week 2 (n= 240, 239, 119)     1.27  ± 0.62     1.21  ± 0.65     1.43  ± 0.64  
Month 1 (n= 237, 240, 116)     1.18  ± 0.68     1.09  ± 0.66     1.40  ± 0.64  
Month 2 (n= 240, 233, 110)     1.05  ± 0.66     0.97  ± 0.68     1.40  ± 0.68  
Month 3 (n= 238, 229, 109)     1.05  ± 0.70     0.97  ± 0.69     1.35  ± 0.73  

No statistical analysis provided for Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 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 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional 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 population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  235     223     55     50  
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 4 (n= 235, 223, 55, 49)     0.97  ± 0.66     0.88  ± 0.68     1.08  ± 0.70     1.09  ± 0.65  
Month 5 (n= 231, 221, 55, 50)     0.95  ± 0.69     0.87  ± 0.69     1.04  ± 0.59     1.03  ± 0.64  
Month 6 (n= 229, 216, 54, 50)     0.94  ± 0.68     0.86  ± 0.67     1.05  ± 0.63     1.00  ± 0.66  

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, 2 and 3   [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

Measure Type Secondary
Measure Title Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Measure Description Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Time Frame Baseline, Week 2, Month 1, 2, 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  241     243     122  
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3  
[units: mm]
Mean ± Standard Deviation
     
Baseline (n= 241, 243, 122)     61.35  ± 22.27     62.03  ± 23.63     61.79  ± 21.27  
Week 2 (n= 239, 239, 119)     45.92  ± 22.87     42.13  ± 25.06     55.61  ± 23.63  
Month 1 (n= 237, 240, 116)     40.68  ± 23.04     36.86  ± 24.46     52.47  ± 24.59  
Month 2 (n= 240, 233, 110)     36.39  ± 23.29     31.66  ± 24.38     52.38  ± 26.09  
Month 3 (n= 237, 228, 108)     34.93  ± 23.73     31.37  ± 24.35     49.84  ± 25.10  

No statistical analysis provided for Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 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 assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  235     223     55     50  
Patient Assessment of Arthritis Pain at Month 4, 5 and 6  
[units: mm]
Mean ± Standard Deviation
       
Month 4 (n= 235, 223, 55, 49)     33.18  ± 23.02     29.70  ± 23.21     34.27  ± 24.53     35.47  ± 25.28  
Month 5 (n= 231, 221, 55, 50)     32.63  ± 23.07     29.10  ± 22.24     34.05  ± 23.48     35.06  ± 24.82  
Month 6 (n= 228, 216, 54, 50)     32.60  ± 23.55     27.89  ± 23.17     33.96  ± 24.62     32.28  ± 23.79  

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, 2 and 3   [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

Measure Type Secondary
Measure Title Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 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 Visual Analog Scale where 0 = very well and 100 = very poorly.
Time Frame Baseline, Week 2, Month 1, 2, 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  240     243     122  
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3  
[units: mm]
Mean ± Standard Deviation
     
Baseline (n= 240, 243, 122)     61.66  ± 22.00     63.46  ± 23.23     62.63  ± 21.91  
Week 2 (n= 240, 239, 119)     46.34  ± 22.36     41.32  ± 24.90     55.95  ± 23.79  
Month 1 (n= 237, 240, 116)     39.63  ± 22.36     37.69  ± 23.94     53.23  ± 24.01  
Month 2 (n= 240, 233, 110)     36.29  ± 22.20     32.56  ± 23.47     53.05  ± 26.04  
Month 3 (n= 238, 229, 108)     35.90  ± 23.61     32.78  ± 23.75     50.48  ± 25.82  

No statistical analysis provided for Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 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 Visual Analog Scale where 0 = very well and 100 = 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  235     223     55     50  
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6  
[units: mm]
Mean ± Standard Deviation
       
Month 4 (n= 235, 223, 55, 49)     33.59  ± 22.44     29.69  ± 22.25     35.27  ± 23.77     36.45  ± 25.92  
Month 5 (n= 231, 221, 55, 50)     34.59  ± 23.37     29.37  ± 22.13     32.88  ± 21.43     33.96  ± 25.02  
Month 6 (n= 228, 216, 54, 50)     32.56  ± 23.09     29.52  ± 22.89     33.51  ± 24.00     32.89  ± 23.78  

No statistical analysis provided for Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6



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

Measure Type Secondary
Measure Title Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 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, 2, 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  241     243     122  
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3  
[units: mm]
Mean ± Standard Deviation
     
Baseline (n= 241, 243, 122)     61.46  ± 16.93     60.84  ± 16.84     62.22  ± 16.85  
Week 2 (n= 239, 240, 119)     43.43  ± 17.69     40.47  ± 19.73     52.15  ± 19.25  
Month 1 (n= 237, 240, 116)     35.89  ± 18.91     33.99  ± 20.37     46.98  ± 22.29  
Month 2 (n= 240, 232, 110)     32.06  ± 20.81     26.75  ± 19.23     44.45  ± 23.62  
Month 3 (n= 238, 229, 109)     29.20  ± 19.98     24.47  ± 18.42     42.05  ± 23.58  

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



21.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

Measure Type Secondary
Measure Title Physician Global Assessment (PGA) of Arthritis Pain 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  235     221     55     50  
Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6  
[units: mm]
Mean ± Standard Deviation
       
Month 4 (n= 235, 221, 54, 49)     25.30  ± 18.56     21.21  ± 16.46     27.48  ± 19.80     25.86  ± 20.32  
Month 5 (n= 231, 221, 55, 50)     23.60  ± 17.63     20.99  ± 16.13     24.74  ± 17.93     25.90  ± 19.85  
Month 6 (n= 229, 216, 54, 50)     23.26  ± 18.12     20.61  ± 16.27     26.16  ± 19.55     21.54  ± 17.51  

No statistical analysis provided for Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6



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

Measure Type Secondary
Measure Title 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Measure Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.
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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  239     243     122  
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline:Physical functioning (n=239,243,122)     30.09  ± 9.31     30.51  ± 8.76     31.41  ± 9.66  
Baseline:Role Physical (n=239,243,122)     32.84  ± 8.87     33.45  ± 8.69     33.33  ± 8.97  
Baseline:Social Functioning (n=239,243,122)     36.78  ± 11.04     36.07  ± 11.27     35.16  ± 10.34  
Baseline:Bodily Pain (n=239,243,122)     32.41  ± 7.57     32.74  ± 7.55     32.77  ± 7.67  
Baseline:Mental Health (n=239,243,122)     40.05  ± 11.49     40.50  ± 12.57     38.43  ± 12.36  
Baseline:Role Emotional (n=239,243,122)     34.26  ± 12.63     36.70  ± 13.03     35.17  ± 13.11  
Baseline:Vitality (n=239,243,122)     41.22  ± 10.06     41.04  ± 10.27     40.13  ± 9.82  
Baseline:General health perception(n=239,243,122)     34.86  ± 8.72     35.71  ± 8.86     34.70  ± 9.00  
Baseline:Mental Component (n=239,243,122)     41.36  ± 11.68     42.19  ± 12.44     39.87  ± 11.62  
Baseline:Physical Component (n=239,243,122)     31.23  ± 8.03     31.37  ± 7.39     32.21  ± 8.35  
Month 3:Physical functioning(n=235,224,108)     36.13  ± 10.44     37.05  ± 10.58     32.93  ± 10.63  
Month 3:Role Physical (n=233,224,107)     38.90  ± 9.41     40.45  ± 9.90     35.19  ± 9.72  
Month 3:Social Functioning(n=235,224,108)     41.62  ± 10.90     43.25  ± 9.95     36.14  ± 10.04  
Month 3:Bodily Pain (n=235,224,108)     40.56  ± 9.38     43.08  ± 9.50     36.35  ± 8.81  
Month 3:Mental Health (n=235,224,108)     44.33  ± 11.50     45.13  ± 11.25     40.73  ± 10.73  
Month 3:Role Emotional (n=233,224,107)     38.76  ± 12.13     40.84  ± 11.57     36.08  ± 12.66  
Month 3:Vitality (n=235,224,108)     47.36  ± 10.69     49.03  ± 9.86     42.23  ± 9.75  
Month 3:General health perception(n=235,224,108)     39.52  ± 9.37     41.50  ± 9.78     37.22  ± 8.75  
Month 3:Mental Component (n=233,224,107)     45.21  ± 11.65     46.58  ± 10.81     41.13  ± 10.90  
Month 3:Physical Component (n=233,224,107)     38.03  ± 9.18     39.69  ± 9.31     34.58  ± 8.94  

No statistical analysis provided for 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 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 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher 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: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  229     216     54     50  
36-Item Short-Form Health Survey (SF-36) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Physical functioning     36.99  ± 10.07     38.43  ± 10.67     35.74  ± 10.23     35.26  ± 9.98  
Role Physical     39.85  ± 9.57     40.93  ± 9.50     38.25  ± 9.73     38.97  ± 9.06  
Social Functioning     42.36  ± 10.60     42.98  ± 10.15     39.57  ± 11.45     43.39  ± 9.78  
Bodily Pain     41.80  ± 9.55     43.67  ± 9.54     40.80  ± 9.36     42.19  ± 9.46  
Mental Health     43.98  ± 12.18     45.05  ± 11.01     42.14  ± 11.90     47.03  ± 10.62  
Role Emotional     40.37  ± 11.32     41.03  ± 11.47     39.04  ± 12.93     42.66  ± 12.10  
Vitality     47.47  ± 10.58     48.89  ± 10.29     45.08  ± 9.50     47.88  ± 9.19  
General health perception     41.05  ± 9.24     42.58  ± 9.84     38.99  ± 8.73     40.42  ± 10.83  
Mental component     45.43  ± 11.58     46.08  ± 10.44     43.29  ± 12.37     48.76  ± 11.06  
Physical component     39.24  ± 8.42     40.89  ± 9.04     37.89  ± 9.56     37.06  ± 9.14  

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



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

Measure Type Secondary
Measure Title Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Measure Description Participant-rated 12 item questionnaire 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 or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.
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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  239     242     122  
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline:overall sleep problem(n=238,242,122)     42.45  ± 18.38     43.09  ± 20.41     47.32  ± 21.24  
Baseline:sleep problem summary(n=239,242,122)     40.59  ± 18.98     42.38  ± 21.01     45.98  ± 21.85  
Baseline:somnolence(n=239,243,122)     37.21  ± 22.47     37.64  ± 21.76     36.56  ± 21.29  
Baseline:snoring(n=238,243,121)     35.71  ± 31.07     30.29  ± 30.50     30.25  ± 31.42  
Baseline:quantity(n=240,243,122)     6.53  ± 1.56     6.38  ± 1.63     6.37  ± 1.74  
Baseline:sleep disturbance(n=238,242,122)     44.44  ± 24.11     43.33  ± 26.18     51.27  ± 25.89  
Baseline:awaken short of breath(n=239,243,122)     18.16  ± 23.76     20.91  ± 25.47     24.92  ± 29.35  
Baseline:adequacy(n=239,243,122)     45.44  ± 27.25     42.63  ± 27.37     40.08  ± 28.36  
Month 3:overall sleep problem(n=236,228,109)     35.53  ± 19.30     33.29  ± 19.96     41.13  ± 21.31  
Month 3:sleep problem summary(n=236,228,109)     34.46  ± 19.89     33.25  ± 20.16     40.55  ± 22.02  
Month 3:somnolence(n=236,229,109)     30.28  ± 21.28     30.45  ± 21.26     35.66  ± 23.01  
Month 3:snoring(n=236,229,109)     32.63  ± 29.61     25.85  ± 27.57     27.52  ± 29.79  
Month 3:quantity(n=237,228,109)     6.77  ± 1.63     6.89  ± 1.45     6.78  ± 1.47  
Month 3:sleep disturbance(n=236,229,109)     36.58  ± 24.67     32.58  ± 24.27     41.16  ± 27.40  
Month 3:awaken short of breath(n=236,228,109)     15.93  ± 21.29     16.23  ± 21.69     22.20  ± 24.99  
Month 3:adequacy(n=236,229,109)     51.69  ± 28.77     52.93  ± 27.75     44.40  ± 27.67  

No statistical analysis provided for Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3



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

Measure Type Secondary
Measure Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 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 by choosing yes or no. Number of participants with optimal sleep are 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 population. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  241     243     122  
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3  
[units: participants]
     
Baseline(n=241,243,122)     96     98     45  
Month 3(n=238,229,109)     113     117     52  

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



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

Measure Type Secondary
Measure Title Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Measure Description Participant-rated 12 item questionnaire 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 or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  229     214     54     50  
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Overall sleep problem     35.68  ± 18.80     33.33  ± 19.19     37.29  ± 19.26     35.64  ± 21.20  
Sleep problem summary     35.17  ± 18.81     33.33  ± 19.66     37.41  ± 20.30     35.87  ± 20.80  
Somnolence     30.26  ± 21.01     29.42  ± 20.64     31.36  ± 19.75     29.60  ± 21.56  
Snoring     35.28  ± 31.04     27.79  ± 28.24     26.30  ± 28.50     29.20  ± 27.47  
Quantity     6.64  ± 1.45     6.87  ± 1.71     6.65  ± 1.52     6.64  ± 1.27  
Sleep disturbance     35.75  ± 25.11     33.38  ± 23.91     37.80  ± 23.96     33.80  ± 25.83  
Awaken short of breath     15.55  ± 21.67     15.70  ± 21.41     21.11  ± 21.43     23.20  ± 25.67  
Adequacy(n=229,214,54,50)     48.52  ± 27.41     53.04  ± 29.14     49.44  ± 29.36     49.00  ± 27.94  

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



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 by choosing yes or no. Number of participants with optimal sleep are 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  229     216     54     50  
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6  
[units: participants]
  105     107     23     25  

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 is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame Baseline, Month 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  240     243     122  
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n= 240, 243, 122)     27.90  ± 10.70     27.72  ± 11.15     27.17  ± 10.88  
Month 3 (n= 237, 227, 109)     34.40  ± 10.65     35.42  ± 9.75     30.06  ± 10.87  

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  229     216     54     50  
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
  34.58  ± 10.69     36.30  ± 10.10     33.63  ± 9.29     36.46  ± 9.27  

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



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

Measure Type Secondary
Measure Title Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 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 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  240     243     122  
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n= 240, 243, 122)     0.41  ± 0.32     0.39  ± 0.32     0.42  ± 0.31  
Month 3 (n= 237, 227, 108)     0.60  ± 0.25     0.66  ± 0.23     0.51  ± 0.31  

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



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

Measure Type Secondary
Measure Title Euro Quality of Life (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: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  227     214     54     49  
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
  0.63  ± 0.23     0.68  ± 0.22     0.58  ± 0.29     0.65  ± 0.21  

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



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

Measure Type Secondary
Measure Title Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and 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 population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  236     239     120  
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline:Seen any doctor(n=236,239,119)     1.19  ± 0.39     1.15  ± 0.36     1.17  ± 0.38  
Baseline:Treated in emergency room(n=236,239,120)     1.94  ± 0.23     1.92  ± 0.26     1.92  ± 0.28  
Baseline:Admitted for overnight stay (n=13,18,10)     0.15  ± 0.55     0.17  ± 0.51     0.20  ± 0.63  
Baseline:Hospitalization(n=236,239,120)     1.94  ± 0.24     1.92  ± 0.27     1.94  ± 0.24  
Baseline:Outpatient surgery(n=236,239,120     1.97  ± 0.16     1.95  ± 0.21     1.98  ± 0.16  
Baseline:Non-study diagnostic test(n=235,239,120)     1.83  ± 0.38     1.78  ± 0.41     1.83  ± 0.37  
Baseline:In nursing home(n=236,239,120)     1.98  ± 0.13     1.99  ± 0.09     1.99  ± 0.09  
Baseline:Home healthcare services(n=235,239,119)     1.99  ± 0.09     1.98  ± 0.13     1.99  ± 0.09  
Baseline:Required aids/devices(n=236,239,119)     1.84  ± 0.37     1.87  ± 0.34     1.83  ± 0.38  
Baseline:Non-medical practitioner(n=236,239,120)     1.97  ± 0.18     1.99  ± 0.09     1.98  ± 0.13  
Baseline:Currently employed(n=236,239,120)     1.69  ± 0.46     1.64  ± 0.48     1.64  ± 0.48  
Baseline:Feel well enough to work(n=111,90,57)     1.86  ± 0.35     1.83  ± 0.37     1.86  ± 0.35  
Baseline:Unable to work due to RA(n=111,93,59)     1.37  ± 0.48     1.29  ± 0.46     1.41  ± 0.50  
Baseline:Lost job/retired early(n=110,92,58)     1.61  ± 0.49     1.55  ± 0.50     1.55  ± 0.50  
Baseline:Work disabled due to RA(n=111,91,58)     1.54  ± 0.50     1.48  ± 0.50     1.52  ± 0.50  
Baseline:Retired(n=116,99,59)     1.57  ± 0.50     1.57  ± 0.50     1.49  ± 0.50  
Baseline:Sick leave due to RA(n=191,202,99)     1.82  ± 0.38     1.83  ± 0.38     1.74  ± 0.44  
Baseline:Performed part time work(n=192,202,98)     1.89  ± 0.31     1.87  ± 0.34     1.88  ± 0.33  
Baseline:Performed paid work(n=191,204,99)     1.64  ± 0.48     1.66  ± 0.48     1.62  ± 0.49  
Baseline:Unable to do chores(n=235,238,118)     1.36  ± 0.48     1.32  ± 0.47     1.30  ± 0.46  
Baseline:Chores by housekeeper(n=235,239,119)     1.86  ± 0.35     1.82  ± 0.39     1.81  ± 0.40  
Baseline:Chores by family/friends(n=235,239,118)     1.40  ± 0.49     1.44  ± 0.50     1.29  ± 0.45  
Month 3:Seen any doctor(n=235,228,109)     1.42  ± 0.49     1.41  ± 0.49     1.39  ± 0.49  
Month 3:Treated in emergency room(n=236,229,109)     1.94  ± 0.24     1.94  ± 0.24     1.93  ± 0.26  
Month 3:Admitted for overnight stay (n=14,14,8)     0.29  ± 0.61     0.43  ± 0.65     0.50  ± 0.93  
Month 3:Hospitalization(n=236,228,109)     1.99  ± 0.09     1.97  ± 0.16     1.98  ± 0.13  
Month 3:Outpatient surgery(n=236,229,109)     1.97  ± 0.17     1.98  ± 0.15     1.98  ± 0.13  
Month 3: Non-study diagnostic test(n=236,228,109)     1.87  ± 0.33     1.88  ± 0.32     1.87  ± 0.34  
Month 3: In nursing home(n=236,229,109)     2.00  ± 0.00     2.00  ± 0.07     1.99  ± 0.10  
Month 3: Home healthcare services(n=236,228,108)     1.99  ± 0.09     2.00  ± 0.00     1.99  ± 0.10  
Month 3: Required aids/devices(n=235,228,109)     1.89  ± 0.32     1.91  ± 0.28     1.87  ± 0.34  
Month 3: Non-medical practitioner(n=236,229,109)     1.98  ± 0.13     2.00  ± 0.07     2.00  ± 0.00  
Month 3: Currently employed(n=236,228,109)     1.71  ± 0.45     1.65  ± 0.48     1.62  ± 0.49  
Month 3: Feel well enough to work(n=108,93,50)     1.72  ± 0.45     1.69  ± 0.47     1.86  ± 0.35  
Month 3: Unable to work due to RA(n=107,98,52)     1.51  ± 0.50     1.48  ± 0.50     1.35  ± 0.48  
Month 3: Lost job/retired early(n=107,92,49)     1.68  ± 0.47     1.70  ± 0.46     1.59  ± 0.50  
Month 3: Work disabled due to RA(n=109,92,49)     1.57  ± 0.50     1.62  ± 0.49     1.47  ± 0.50  
Month 3: Retired(n=115,107,51)     1.52  ± 0.50     1.51  ± 0.50     1.53  ± 0.50  
Month 3: Sick leave due to RA(n=180,183,88)     1.93  ± 0.26     1.91  ± 0.29     1.89  ± 0.32  
Month 3: Performed part time work(n=181,180,88)     1.94  ± 0.23     1.94  ± 0.24     1.90  ± 0.30  
Month 3: Performed paid work(n=179,184,88)     1.75  ± 0.44     1.76  ± 0.43     1.65  ± 0.48  
Month 3: Unable to do chores(n=231,227,107)     1.60  ± 0.49     1.63  ± 0.49     1.39  ± 0.49  
Month 3: Chores by housekeeper(n=235,229,108)     1.88  ± 0.32     1.92  ± 0.28     1.79  ± 0.41  
Month 3: Chores by family/friends(n=234,229,108)     1.65  ± 0.48     1.64  ± 0.48     1.49  ± 0.50  

No statistical analysis provided for Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and 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 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 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  229     216     54     50  
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Month 6:Seen any doctor(n=227,216,54,50)     1.30  ± 0.46     1.30  ± 0.46     1.28  ± 0.45     1.28  ± 0.45  
Month 6:Treated in emergency room(n=229,216,54,50)     1.93  ± 0.26     1.94  ± 0.24     1.94  ± 0.23     1.96  ± 0.20  
Month 6:Admitted for overnight stay (n=16,13,3,2)     0.25  ± 0.58     0.23  ± 0.44     1.33  ± 2.31     1.00  ± 1.41  
Month 6:Hospitalization(n=229,216,54,50)     1.98  ± 1.15     1.99  ± 1.12     1.96  ± 1.19     1.96  ± 0.20  
Month 6:Outpatient surgery(n=229,216,54,50)     1.99  ± 0.11     1.94  ± 0.23     2.00  ± 0.00     1.96  ± 0.20  
Month 6:Diagnostic test(n=229,216,54,50)     1.87  ± 0.34     1.84  ± 0.37     1.87  ± 0.34     1.88  ± 0.33  
Month 6:In nursing home(n=229,216,54,50)     2.00  ± 0.07     2.00  ± 0.07     2.00  ± 0.00     2.00  ± 0.00  
Month 6:Home healthcare services(n=229,216,54,49)     1.99  ± 0.11     2.00  ± 0.07     1.96  ± 0.19     1.98  ± 0.14  
Month 6:Required aids/devices(n=229,216,54,50)     1.89  ± 0.31     1.94  ± 0.24     1.89  ± 0.32     1.92  ± 0.27  
Month 6:Non-medical practitioner(n=229,216,54,50)     2.00  ± 0.00     1.99  ± 0.10     1.98  ± 0.14     2.00  ± 0.00  
Month 6:Currently employed(n=229,216,54,50)     1.71  ± 0.46     1.65  ± 0.48     1.59  ± 0.50     1.58  ± 0.50  
Month 6:Feel well enough to work(n=124,101,24,22)     1.73  ± 0.45     1.66  ± 0.47     1.71  ± 0.46     1.73  ± 0.46  
Month 6:Unable to work due to RA(n=123,105,24,24)     1.50  ± 0.50     1.46  ± 0.50     1.54  ± 0.51     1.42  ± 0.50  
Month 6:Lost job/retired early(n=126,102,24,23)     1.73  ± 0.45     1.63  ± 0.49     1.54  ± 0.51     1.57  ± 0.51  
Month 6:Work disabled due to RA(n=125,103,24,23)     1.62  ± 0.49     1.54  ± 0.50     1.54  ± 0.51     1.43  ± 0.51  
Month 6:Retired(n=126,110,25,23)     1.51  ± 0.50     1.45  ± 0.50     1.56  ± 0.51     1.48  ± 0.51  
Month 6:Sick leave due to RA(n=175,169,41,41)     1.94  ± 0.23     1.94  ± 0.24     1.93  ± 0.26     1.95  ± 0.22  
Month 6:Performed part time work(n=173,170,40,41)     1.93  ± 0.25     1.96  ± 0.19     1.93  ± 0.27     1.95  ± 0.22  
Month 6:Performed paid work(n=172,169,39,41)     1.80  ± 0.40     1.80  ± 0.40     1.64  ± 0.49     1.73  ± 0.45  
Month 6:Unable to do chores(n=229,214,52,50)     1.62  ± 0.49     1.69  ± 0.46     1.54  ± 0.50     1.70  ± 0.46  
Month 6:Chores by housekeeper(n=229,216,54,50)     1.89  ± 0.31     1.94  ± 0.25     1.85  ± 0.36     1.98  ± 0.14  
Month 6:Chores by family/friends(n=229,216,54,50)     1.67  ± 0.47     1.70  ± 0.46     1.54  ± 0.50     1.74  ± 0.44  

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 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  193     205     102  
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3  
[units: events]
Mean ± Standard Deviation
     
Baseline:Doctor visit(n=193,204,102)     4.38  ± 4.50     3.85  ± 4.07     3.56  ± 2.73  
Baseline:RA related doctor visit (n=192,205,100)     1.26  ± 0.81     1.18  ± 0.85     1.33  ± 0.89  
Baseline:Hospital ER visit(n=13,18,10)     1.15  ± 0.38     1.61  ± 1.29     1.40  ± 0.70  
Baseline:RA related ER visit(n=12,18,10)     0.75  ± 0.75     0.50  ± 0.62     0.80  ± 0.92  
Baseline:Hospitalization(n=14,19,7)     1.07  ± 0.27     1.11  ± 0.32     1.00  ± 0.00  
Baseline:RA related hospitalization(n=14,19,8)     1.00  ± 0.55     0.84  ± 0.60     0.88  ± 0.64  
Baseline:Outpatient surgery(n=6,11,2)     1.00  ± 0.00     1.00  ± 0.00     1.00  ± 0.00  
Baseline:RA related outpatient surgery(n=6,11,3)     0.00  ± 0.00     0.55  ± 0.82     0.00  ± 0.00  
Baseline:Non-study diagnostic test(n=39,51,17)     1.69  ± 1.22     1.94  ± 1.22     1.59  ± 1.06  
Baseline:RA related diagnostic test(n=41,52,19)     0.61  ± 0.67     0.83  ± 0.94     0.95  ± 0.97  
Baseline:Non-medical practitioner visit(n=8,2,2)     12.00  ± 12.99     7.00  ± 7.07     1.00  ± 0.00  
Baseline:RA related non-medical visit(n=8,2,2)     1.13  ± 0.64     1.50  ± 0.71     0.50  ± 0.71  
Month 3:Doctor visit(n=141,137,66)     3.60  ± 2.40     3.64  ± 3.44     4.00  ± 3.12  
Month 3:RA related doctor visit(n=142,138,66)     0.83  ± 0.67     0.81  ± 0.81     0.92  ± 0.81  
Month 3:Hospital ER visit(n=14,14,8)     1.21  ± 0.80     1.29  ± 0.47     1.50  ± 0.76  
Month 3:RA related ER visit(n=14,13,8)     0.14  ± 0.53     0.15  ± 0.55     0.25  ± 0.46  
Month 3:Hospitalization(n=2,6,2)     1.00  ± 0.00     1.17  ± 0.41     1.00  ± 0.00  
Month 3:RA related hospitalization(n=2,7,2)     0.50  ± 0.71     0.00  ± 0.00     0.00  ± 0.00  
Month 3:Outpatient surgery(n=7,5,2)     1.14  ± 0.38     1.60  ± 0.89     1.00  ± 0.00  
Month 3:RA related outpatient surgery(n=7,5,2)     0.29  ± 0.76     0.00  ± 0.00     1.00  ± 1.41  
Month 3:Non-study diagnostic test(n=27,25,13)     1.26  ± 0.81     1.60  ± 0.82     1.54  ± 0.78  
Month 3:RA related diagnostic test(n=30,26,14)     0.13  ± 0.35     0.15  ± 0.37     0.21  ± 0.43  
Month 3:Non-medical practitioner visit(n=4,1,0)     10.75  ± 6.99     7.00  ± NA [1]   NA  ± NA [2]
Month 3:RA related non-medical visit(n=4,1,0)     0.25  ± 0.50     2.00  ± NA [1]   NA  ± NA [2]
[1] Standard deviation was not estimable as only 1 participant was evaluable.
[2] Data was not analyzed as no participant was evaluable for this parameter.

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 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  159     152     39     36  
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6  
[units: events]
Mean ± Standard Deviation
       
Doctor visit(n=159,152,39,36)     3.22  ± 2.54     3.69  ± 3.18     3.00  ± 2.29     3.69  ± 2.25  
RA related doctor visit(n=159,152,39,36)     0.92  ± 0.70     0.83  ± 0.73     1.05  ± 0.60     0.92  ± 0.69  
Hospital ER visit(n=16,13,3,2)     1.06  ± 0.25     1.25  ± 0.45     3.00  ± 1.73     1.00  ± 0.00  
RA related ER visit(n=16,12,3,2)     0.13  ± 0.34     0.08  ± 0.28     1.67  ± 2.08     0.00  ± 0.00  
Hospitalization(n=5,3,2,2)     1.20  ± 0.45     1.00  ± 0.00     1.50  ± 0.71     1.00  ± 0.00  
RA related hospitalization(n=5,3,2,2)     0.20  ± 0.45     0.33  ± 0.58     0.50  ± 0.71     0.00  ± 0.00  
Outpatient surgery(n=3,10,0,2)     1.00  ± 0.00     1.50  ± 1.58     NA  ± NA [1]   1.00  ± 0.00  
RA related outpatient surgery(n=3,12,0,2)     0.00  ± 0.00     0.00  ± 0.00     NA  ± NA [1]   0.00  ± 0.00  
Non-study diagnostic test(n=24,33,7,5)     2.04  ± 1.55     1.39  ± 0.75     2.57  ± 1.62     1.20  ± 0.45  
RA related diagnostic test(n=29,34,6,6)     0.45  ± 0.87     0.29  ± 0.52     0.67  ± 0.82     0.33  ± 0.52  
Non-medical practitioner visit(n=0,2,0,0)     NA  ± NA [1]   3.00  ± 1.41     NA  ± NA [1]   NA  ± NA [1]
RA related non-medical visit(n=0,2,0,0)     NA  ± NA [1]   0.50  ± 0.71     NA  ± NA [1]   NA  ± NA [1]
[1] Data was not analyzed as no participant was evaluable for this parameter.

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.
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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  139     131     84  
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3  
[units: days]
Mean ± Standard Deviation
     
Baseline:Hospital length of stay(n=14,19,7)     15.43  ± 12.33     9.63  ± 7.27     4.29  ± 2.81  
Baseline:Days in nursing home(n=4,2,1)     23.25  ± 2.63     16.50  ± 6.36     10.00  ± NA [1]
Baseline:Days devices/aids used(n=37,31,20)     118.95  ± 134.74     85.52  ± 95.38     55.90  ± 56.66  
Baseline:RA related aids used(n=38,31,20)     2.21  ± 1.47     1.90  ± 1.33     1.45  ± 0.69  
Baseline:Days of work per week(n=72,84,43)     5.08  ± 1.04     4.92  ± 1.17     5.02  ± 0.96  
Baseline:Days on sick leave(n=33,34,25)     25.12  ± 33.23     10.91  ± 18.15     22.40  ± 29.72  
Baseline:Days of part time work(n=20,25,12)     15.65  ± 22.74     20.44  ± 26.71     12.42  ± 10.57  
Baseline:Paid work, bothered by RA(n=69,68,37)     33.87  ± 31.01     28.15  ± 29.06     38.30  ± 27.52  
Baseline:Chores by housekeeper(n=33,43,22)     17.30  ± 24.67     16.63  ± 25.99     14.55  ± 22.32  
Baseline:Chores by family(n=139,131,84)     29.54  ± 31.72     27.85  ± 34.80     22.12  ± 27.36  
Month 3:Hospital length of stay(n=2,6,2)     7.50  ± 6.36     6.33  ± 7.12     12.00  ± 2.83  
Month 3:Days in nursing home(n=0,1,1)     NA  ± NA [2]   2.0  ± NA [1]   10.0  ± NA [1]
Month 3:Days devices/aids used(n=27,20,14)     109.93  ± 107.85     89.50  ± 89.98     94.68  ± 111.05  
Month 3:RA related aids used(n=27,20,14)     1.81  ± 1.36     1.50  ± 0.95     1.93  ± 1.21  
Month 3:Days of work per week(n=68,79,41)     5.00  ± 0.93     5.05  ± 1.19     4.88  ± 1.17  
Month 3:Days on sick leave(n=13,17,10)     15.00  ± 23.59     14.82  ± 23.32     19.60  ± 27.68  
Month 3:Days of part time work(n=10,11,9)     12.70  ± 20.97     19.09  ± 25.07     6.22  ± 5.70  
Month 3:Paid work, bothered by RA(n=44,44,30)     21.70  ± 26.22     19.39  ± 23.10     26.50  ± 27.03  
Month 3:Chores by housekeeper(n=26,19,23)     7.73  ± 8.43     6.32  ± 5.73     18.13  ± 25.19  
Month 3:Chores by family(n=81,82,55)     25.72  ± 31.12     27.29  ± 33.02     27.00  ± 30.37  
[1] Standard deviation was not estimable as only 1 participant was evaluable.
[2] Data was not analyzed as no participant was evaluable for this parameter.

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.
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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  74     75     24     21  
Number of Days as Assessed Using RA-HCRU at Month 6  
[units: days]
Mean ± Standard Deviation
       
Hospital length of stay(n=5,3,2,2)     13.60  ± 18.28     7.67  ± 5.86     13.50  ± 14.85     1.50  ± 0.71  
Days in nursing home(n=1,1,0,0)     24.00  ± NA [1]   15.00  ± NA [1]   NA  ± NA [2]   NA  ± NA [2]
Days devices/aids used(n=24,13,6,4)     97.17  ± 116.84     53.85  ± 52.29     101.50  ± 106.85     72.25  ± 113.10  
RA related aids used(n=25,12,6,4)     1.48  ± 1.23     1.67  ± 0.98     2.17  ± 1.83     1.75  ± 0.96  
Days of work per week(n=65,75,22,21)     4.95  ± 0.84     5.16  ± 0.99     5.09  ± 1.15     4.71  ± 1.19  
Days on sick leave(n=10,10,3,2)     21.10  ± 27.23     15.50  ± 27.71     9.00  ± 5.20     47.50  ± 60.10  
Days of part time work(n=11,6,3,2)     15.00  ± 25.46     8.50  ± 5.68     5.00  ± 3.00     4.00  ± 4.24  
Paid work, bothered by RA(n=34,32,14,12)     21.09  ± 25.89     12.72  ± 17.50     26.14  ± 29.98     15.92  ± 18.80  
Chores by housekeeper(n=25,13,8,1)     16.32  ± 24.40     20.23  ± 31.76     8.50  ± 11.78     90.00  ± NA [1]
Chores by family(n=74,64,24,13)     20.38  ± 27.42     28.09  ± 32.55     11.58  ± 18.35     27.38  ± 30.61  
[1] Standard deviation was not estimable as only 1 participant was evaluable.
[2] Data was not analyzed as no participant was evaluable for this parameter.

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, work done and work missed 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  139     131     82  
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=1,4,1)     2.00  ± NA [1]   3.75  ± 5.50     1.00  ± NA [1]
Baseline:RA related home HC services(n=2,4,1)     1.50  ± 0.71     2.25  ± 2.50     1.00  ± NA [1]
Baseline:Work done(n=71,85,43)     7.66  ± 1.87     8.60  ± 6.12     8.95  ± 5.20  
Baseline:Missed work due to RA(n=19,25,12)     3.47  ± 2.67     10.84  ± 24.54     6.17  ± 12.29  
Baseline:Chores by housekeeper(n=33,43,22)     5.64  ± 4.06     4.67  ± 2.07     5.86  ± 3.06  
Baseline:Chores by family(n=139,131,82)     3.99  ± 4.02     3.32  ± 2.89     4.85  ± 6.88  
Month 3:Home healthcare services(n=2,0,1)     2.50  ± 2.12     NA  ± NA [2]   1.00  ± NA [1]
Month 3:RA related home HC services(n=2,0,1)     0.50  ± 0.71     NA  ± NA [2]   0.00  ± NA [1]
Month 3:Work done(n=66,79,41)     8.20  ± 7.28     7.68  ± 2.37     8.85  ± 5.34  
Month 3:Missed work due to RA(n=10,9,9)     2.20  ± 1.55     3.67  ± 1.41     9.56  ± 19.04  
Month 3:Chores by housekeeper(n=27,19,23)     5.74  ± 4.70     5.21  ± 4.89     5.91  ± 4.75  
Month 3:Chores by family(n=79,82,54)     3.09  ± 1.96     3.82  ± 6.91     3.69  ± 3.82  
[1] Standard deviation was not estimable as only 1 participant was evaluable.
[2] Data was not analyzed as no participant was evaluable for this parameter.

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 Days as Assessed Using RA-HCRU at Month 6   [ Time Frame: Month 6 ]

Measure Type Secondary
Measure Title Number of Hours Per 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 hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  74     75     24     21  
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6  
[units: hours per day]
Mean ± Standard Deviation
       
Home healthcare services(n=3,1,1,1)     4.00  ± 1.00     1.00  ± NA [1]   0.00  ± NA [1]   1.00  ± NA [1]
RA related home healthcare services(3,1,2,1)     1.00  ± 1.00     1.00  ± NA [1]   0.00  ± 0.00     0.00  ± NA [1]
Work done(n=65,75,22,21)     8.38  ± 5.53     8.43  ± 4.16     7.23  ± 2.11     8.29  ± 1.79  
Missed work due to RA(n=11,7,3,2)     2.73  ± 2.53     2.57  ± 1.72     2.67  ± 2.31     1.50  ± 2.12  
Chores by housekeeper(n=24,14,8,1)     5.13  ± 2.49     10.57  ± 22.97     5.00  ± 2.45     8.00  ± NA [1]
Chores by family(n=74,64,24,13)     3.11  ± 2.18     2.86  ± 1.80     3.29  ± 2.84     4.69  ± 6.46  
[1] Standard deviation was not estimable as only 1 participant was evaluable.

No statistical analysis provided for Number of Hours Per Days as Assessed Using 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 a 0 to 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  148     174     79  
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=146, 174, 79)     5.59  ± 3.17     5.61  ± 6.42     5.41  ± 2.94  
Month 3 (n=138, 148, 75)     3.39  ± 2.85     3.43  ± 2.88     4.57  ± 2.94  

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 a 0 to 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: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  130     138     34     34  
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
  3.22  ± 2.85     3.18  ± 3.00     3.21  ± 2.80     3.94  ± 3.22  

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 (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  124     122     67  
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline:Time management(n=118, 119, 62)     50.84  ± 26.52     48.98  ± 27.17     48.74  ± 26.44  
Baseline:Physical demands(n=117, 119, 66)     51.84  ± 22.44     49.24  ± 27.51     51.21  ± 25.33  
Baseline:Mental demands(n=119,120,66)     31.04  ± 24.05     36.14  ± 28.41     38.69  ± 27.76  
Baseline:Output demands(n=114, 116, 63)     39.70  ± 24.76     44.85  ± 30.23     45.30  ± 28.11  
Baseline:Work loss index(n=124, 122, 67)     10.82  ± 5.21     11.95  ± 6.20     12.16  ± 5.92  
Month 3:Time management(n=94, 89, 45)     37.65  ± 29.03     34.63  ± 29.91     41.32  ± 23.28  
Month 3:Physical demands(n=98, 90, 46)     51.89  ± 29.32     46.48  ± 30.17     46.71  ± 24.78  
Month 3:Mental demands(n=100, 93, 47)     24.64  ± 27.02     24.62  ± 29.12     28.54  ± 26.40  
Month 3:Output demands(n=96, 90, 45)     27.03  ± 24.44     28.31  ± 29.37     33.41  ± 23.28  
Month 3:Work loss index(n=102, 98, 49)     8.48  ± 5.60     8.05  ± 6.63     9.29  ± 5.66  

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 (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, 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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given parameter for each group respectively.

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 Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

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]
  85     85     26     27  
Work Limitations Questionnaire (WLQ) Score at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Time management (n=80, 81, 25, 23)     36.27  ± 29.22     30.42  ± 28.39     34.40  ± 25.59     39.86  ± 30.64  
Physical demands (n=85, 81, 26, 25)     45.37  ± 29.86     45.17  ± 34.14     57.16  ± 27.63     50.33  ± 31.74  
Mental demands (n= 81, 82, 25, 26)     22.66  ± 25.71     21.61  ± 29.09     25.84  ± 24.54     29.77  ± 29.64  
Output demands (n= 80, 81, 26, 23)     25.04  ± 24.29     26.30  ± 29.40     28.65  ± 23.90     35.05  ± 29.32  
Work loss index (n= 85, 85, 26, 27)     7.85  ± 5.64     7.60  ± 6.49     9.07  ± 5.22     9.23  ± 6.26  

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



44.  Other Pre-specified:   Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain   [ Time Frame: 2 weeks ]

Measure Type Other Pre-specified
Measure Title Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Measure Description Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Time Frame 2 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  59     61     31  
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain  
[units: days]
  3     3     3  

No statistical analysis provided for Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain



45.  Other Pre-specified:   Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis   [ Time Frame: 2 weeks ]

Measure Type Other Pre-specified
Measure Title Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
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 Visual Analog Scale where 0 = very well and 100 = very poorly.
Time Frame 2 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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 Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  59     61     31  
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis  
[units: days]
  3     3     3  

No statistical analysis provided for Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis




  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00814307     History of Changes
Other Study ID Numbers: A3921045
Study First Received: December 22, 2008
Results First Received: December 5, 2012
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration