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Trial record 1 of 1 for:    NCT00847613
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A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

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ClinicalTrials.gov Identifier: NCT00847613
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : January 9, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: CP-690,550
Drug: Placebo
Enrollment 800
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24. CP-690,550 10 mg tablet orally twice daily up to Month 24. Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24. Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Period Title: Overall Study
Started 321 319 81 79
Treated 321 316 81 79
Completed 0 0 0 0
Not Completed 321 319 81 79
Reason Not Completed
Ongoing at cut-off date             250             265             64             64
Death             1             1             0             0
Adverse Event             36             26             5             6
Lack of Efficacy             7             3             3             1
Study terminated by Sponsor             1             0             2             1
Lost to Follow-up             5             0             0             3
Protocol Violation             6             6             3             1
Pregnancy             1             1             0             0
Site closure             1             0             0             1
Withdrawal by Subject             8             11             2             2
Participant moved             4             1             0             0
Sponsor request             0             1             0             0
Randomized, but not treated             0             3             0             0
Other             1             1             2             0
Arm/Group Title 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
Hide Arm/Group Description CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24. CP-690,550 10 mg tablet orally twice daily up to Month 24. Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24. Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24. Total of all reporting groups
Overall Number of Baseline Participants 321 316 81 79 797
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 321 participants 316 participants 81 participants 79 participants 797 participants
53.7  (11.6) 52.0  (11.4) 53.2  (11.5) 52.1  (11.8) 52.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 321 participants 316 participants 81 participants 79 participants 797 participants
Female
269
  83.8%
273
  86.4%
65
  80.2%
72
  91.1%
679
  85.2%
Male
52
  16.2%
43
  13.6%
16
  19.8%
7
   8.9%
118
  14.8%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Hide 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). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using Non-responder Imputation (NRI) method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 309 154
Measure Type: Number
Unit of Measure: percentage of participants
51.46 61.81 25.32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg, Placebo
Comments Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 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.
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 36.48
Confidence Interval (2-Sided) 95%
27.73 to 45.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg, Placebo
Comments Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 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.
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 26.13
Confidence Interval (2-Sided) 95%
17.28 to 34.97
Estimation Comments [Not Specified]
2.Primary Outcome
Title Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6
Hide Description mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 286 295 139
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 28.66  (2.98) 34.66  (2.95) 29.53  (4.25)
Change at Month 6 0.12  (0.12) 0.06  (0.11) 0.47  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg, Placebo
Comments Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0376
Comments 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.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.79 to -0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg, Placebo
Comments Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0792
Comments 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.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.73 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 315 309 156
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.41  (0.68) 1.39  (0.66) 1.31  (0.68)
Change at Month 3 -0.3  (0.45) -0.4  (0.48) -0.1  (0.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg, Placebo
Comments Change at Month 3: Least squares mean difference and corresponding 95% confidence interval (CI) was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 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 mTSS had to be significant.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.49 to -0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg, Placebo
Comments Change at Month 3: Least squares mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments 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 mTSS had to be statistically significant.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.34 to -0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments [Not Specified]
4.Primary Outcome
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 6
Hide 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. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 257 129
Measure Type: Number
Unit of Measure: percentage of participants
7.17 15.95 1.55
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg, Placebo
Comments Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 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.
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 14.40
Confidence Interval (2-Sided) 95%
9.44 to 19.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg, Placebo
Comments Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments 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.
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 5.61
Confidence Interval (2-Sided) 95%
1.85 to 9.38
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3
Hide 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 HAQ); and CRP.
Time Frame Month 1, 3
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 309 154
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 41.42 52.10 16.34
Month 3 56.31 66.34 27.27
6.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24
Hide 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 HAQ); and CRP.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 309 79 75
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 47.90 62.46 32.91 29.33
Month 12 48.54 56.96 30.38 33.33
7.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 309 154
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 16.83 18.45 1.31
Month 3 28.80 36.25 7.79
Month 6 32.36 43.69 8.44
8.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24
Hide 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 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 309 79 75
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 32.69 44.01 22.78 20.00
Month 12 32.69 41.10 21.52 16.00
9.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 309 154
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 3.88 3.56 0.00
Month 3 10.68 17.15 2.60
Month 6 14.56 22.33 1.30
10.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24
Hide 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 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 309 79 75
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 18.45 28.48 8.86 12.00
Month 12 18.77 27.51 10.13 12.00
11.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Hide 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 Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 156
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=316,309,156) 5.22  (0.88) 5.20  (0.87) 5.16  (0.87)
Month 1 (n=309,308,152) 4.04  (1.14) 3.84  (1.09) 4.73  (1.10)
Month 3 (n=294,299,145) 3.62  (1.13) 3.29  (1.14) 4.54  (1.18)
Month 6 (n=283,285,62) 3.33  (1.12) 2.96  (1.09) 3.79  (1.06)
12.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24
Hide 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 indicated low disease activity, >3.2 to 5.1 indicated moderate to high disease activity and <2.6 = remission.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 278 69 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 9 3.11  (1.17) 2.88  (1.20) 2.99  (1.11) 3.03  (1.06)
Month 12 3.07  (1.23) 2.75  (1.14) 3.05  (1.18) 2.91  (1.05)
13.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Hide Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 306 154
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=316,306,154) 6.34  (0.97) 6.25  (0.99) 6.27  (1.01)
Month 1 (n=258,250,127) 5.12  (1.32) 4.84  (1.28) 5.83  (1.17)
Month 3 (n=249,248,122) 4.58  (1.29) 4.19  (1.34) 5.57  (1.23)
Month 6 (n=239,236,49) 4.34  (1.24) 3.90  (1.31) 4.81  (1.21)
14.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24
Hide Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 227 229 56 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 9 4.12  (1.26) 3.84  (1.35) 4.04  (1.33) 3.87  (1.30)
Month 12 4.09  (1.31) 3.79  (1.34) 4.20  (1.41) 3.84  (1.35)
15.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Hide Description DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Hide Description DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Modified Total Sharp Scores (mTSS) at Baseline
Hide Description mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 286 295 139
Mean (Standard Deviation)
Unit of Measure: units on a scale
31.1  (47.71) 37.3  (54.10) 32.6  (41.80)
18.Secondary Outcome
Title Modified Total Sharp Scores (mTSS) at Month 12 and 24
Hide Description mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame Month 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for Month 24 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 286 295 71 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
31.4  (47.88) 37.3  (54.03) 36.1  (43.59) 30.9  (41.18)
19.Secondary Outcome
Title Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; 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 where 0=least difficulty and 3=extreme difficulty.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 315 309 156
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=315,309,156) 1.41  (0.68) 1.39  (0.66) 1.31  (0.68)
Month 1 (n=309,308,153) 1.16  (0.67) 1.02  (0.65) 1.25  (0.67)
Month 3 (n=295,300,146) 1.00  (0.65) 0.84  (0.65) 1.19  (0.69)
Month 6 (n=283,285,62) 0.94  (0.62) 0.79  (0.64) 1.09  (0.62)
20.Secondary Outcome
Title Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; 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 where 0=least difficulty and 3=extreme difficulty.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 278 69 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 9 0.91  (0.65) 0.75  (0.64) 0.95  (0.66) 0.74  (0.67)
Month 12 0.90  (0.65) 0.76  (0.68) 0.84  (0.66) 0.74  (0.68)
21.Secondary Outcome
Title Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 156
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=316,309,156) 58.39  (23.08) 57.62  (24.10) 55.01  (23.87)
Month 1 (n=309,308,153) 41.61  (24.08) 33.91  (22.30) 49.22  (24.51)
Month 3 (n=295,300,146) 34.47  (23.49) 29.23  (21.95) 46.96  (24.02)
Month 6 (n=283,285,62) 32.79  (22.90) 29.05  (22.71) 36.76  (22.14)
22.Secondary Outcome
Title Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 278 69 63
Mean (Standard Deviation)
Unit of Measure: mm
Month 9 31.59  (23.13) 27.14  (23.10) 31.74  (23.26) 27.54  (23.12)
Month 12 30.54  (23.00) 27.45  (24.56) 27.99  (23.55) 29.41  (26.22)
23.Secondary Outcome
Title Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6
Hide Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 308 156
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=316,308,156) 58.06  (23.62) 56.45  (22.96) 54.11  (22.87)
Month 1 (n=309,308,153) 41.26  (23.69) 34.95  (21.43) 48.30  (24.47)
Month 3 (n=295,300,146) 35.07  (22.68) 29.11  (20.54) 46.96  (24.09)
Month 6 (n=283,285,62) 33.48  (22.39) 29.03  (22.68) 38.87  (23.17)
24.Secondary Outcome
Title Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24
Hide Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 278 69 63
Mean (Standard Deviation)
Unit of Measure: mm
Month 9 31.19  (22.10) 28.05  (22.46) 31.46  (23.22) 27.41  (23.22)
Month 12 31.77  (22.55) 29.12  (24.06) 29.60  (23.15) 28.11  (24.09)
25.Secondary Outcome
Title Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6
Hide Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 156
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=316,309,156) 59.44  (15.87) 58.42  (17.08) 55.90  (17.37)
Month 1 (n=309,308,152) 37.97  (18.58) 35.19  (19.29) 45.50  (19.57)
Month 3 (n=294,300,146) 30.12  (18.61) 24.47  (17.51) 43.29  (22.25)
Month 6 (n=283,284,61) 25.47  (18.62) 20.44  (15.75) 26.61  (17.73)
26.Secondary Outcome
Title Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24
Hide Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 264 278 69 62
Mean (Standard Deviation)
Unit of Measure: mm
Month 9 21.68  (16.14) 18.90  (15.89) 19.92  (17.59) 19.29  (15.53)
Month 12 20.40  (15.71) 17.97  (15.08) 20.42  (16.63) 18.79  (15.42)
27.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 315 309 156
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline:physical functioning(n=315,309,156) 32.16  (9.98) 32.61  (9.86) 33.50  (10.70)
Baseline:role physical(n=315,309,156) 34.61  (9.40) 35.41  (9.73) 36.69  (10.54)
Baseline:social functioning(n=315,309,156) 37.16  (11.05) 39.17  (11.42) 39.37  (11.54)
Baseline:bodily pain(n=315,309,156) 34.01  (7.52) 34.64  (7.89) 35.57  (8.05)
Baseline:mental health(n=315,309,156) 39.94  (11.30) 40.45  (11.15) 42.03  (11.28)
Baseline:role emotional(n=315,309,156) 35.64  (12.67) 36.25  (13.37) 37.43  (13.82)
Baseline:vitality(n=315,309,156) 40.62  (9.90) 42.53  (9.67) 42.97  (9.95)
Baseline:general health(n=315,309,156) 35.16  (9.07) 36.03  (8.79) 36.82  (8.11)
Baseline:mental component(n=315,309,156) 41.01  (11.54) 42.24  (11.52) 43.21  (11.90)
Baseline:physical component(n=315,309,156) 33.05  (7.94) 33.75  (7.77) 34.51  (8.03)
Month 1:physical functioning(n=308,308,153) 34.61  (9.96) 36.72  (10.01) 35.27  (10.48)
Month 1:role physical(n=307,308,153) 39.21  (10.04) 41.02  (9.81) 38.30  (10.24)
Month 1:social functioning(n=308,308,153) 41.70  (10.44) 43.54  (10.06) 41.01  (11.57)
Month 1:bodily pain(n=308,308,153) 39.75  (8.08) 42.02  (8.41) 37.31  (8.93)
Month 1:mental health(n=308,308,153) 43.70  (11.76) 44.88  (10.82) 42.70  (11.98)
Month 1:role emotional(n=307,308,153) 39.06  (12.34) 41.13  (12.03) 38.53  (12.47)
Month 1:vitality(n=308,308,153) 45.33  (10.33) 46.84  (9.77) 43.82  (10.40)
Month 1:general health(n=308,308,153) 38.49  (9.28) 39.91  (9.00) 37.70  (8.85)
Month 1:mental component(n=307,308,153) 44.90  (11.74) 46.28  (10.70) 43.86  (11.90)
Month 1:physical component(n=307,308,153) 36.99  (8.24) 38.96  (8.07) 36.25  (8.24)
Month 3:physical functioning(n=295,300,146) 36.40  (10.51) 39.34  (10.66) 35.39  (10.66)
Month 3:role physical(n=295,300,146) 39.83  (10.11) 42.82  (9.98) 38.37  (10.65)
Month 3:social functioning(n=295,300,146) 42.73  (10.60) 44.50  (10.27) 40.86  (11.23)
Month 3:bodily pain(n=295,300,146) 41.30  (9.23) 44.43  (9.02) 38.17  (9.16)
Month 3:mental health(n=295,300,146) 43.84  (11.82) 45.52  (10.50) 42.80  (11.47)
Month 3:role emotional(n=295,300,146) 39.52  (12.64) 43.12  (11.97) 38.20  (13.46)
Month 3:vitality(n=295,300,146) 46.72  (10.31) 48.60  (9.52) 44.24  (10.15)
Month 3:general health(n=294,300,146) 39.76  (9.31) 41.20  (8.84) 38.24  (8.79)
Month 3:mental component(n=294,300,146) 45.22  (11.69) 47.05  (10.27) 43.70  (11.68)
Month 3:physical component(n=294,300,146) 38.65  (8.62) 41.30  (8.49) 36.79  (8.39)
Month 6:physical functioning(n=283,284,62) 37.33  (10.51) 39.76  (10.71) 37.60  (8.70)
Month 6:role physical(n=282,284,62) 41.46  (10.16) 43.37  (9.62) 41.38  (8.78)
Month 6:social functioning(n=283,285,62) 42.99  (10.58) 44.87  (10.53) 42.79  (9.48)
Month 6:bodily pain(n=283,285,62) 41.90  (8.81) 44.18  (9.37) 40.70  (8.06)
Month 6:mental health(n=283,285,62) 44.46  (11.86) 45.60  (11.34) 43.37  (8.46)
Month 6:role emotional(n=282,284,62) 40.58  (12.54) 42.71  (11.69) 41.88  (10.80)
Month 6:vitality(n=283,285,62) 46.58  (10.11) 48.52  (9.42) 46.31  (9.14)
Month 6:general health(n=283,285,62) 40.40  (9.14) 41.78  (9.24) 39.90  (7.03)
Month 6:mental component(n=282,284,62) 45.39  (11.86) 46.82  (10.85) 45.42  (9.35)
Month 6:physical component(n=282,284,62) 39.69  (8.39) 41.78  (8.56) 39.21  (6.99)
28.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24
Hide 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 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 264 278 69 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 9:physical functioning 37.94  (10.38) 40.66  (10.70) 38.31  (10.62) 41.29  (11.80)
Month 9:role physical 41.41  (10.30) 43.96  (9.86) 41.48  (9.87) 44.96  (10.21)
Month 9:social functioning 44.16  (10.13) 45.20  (10.67) 43.70  (10.10) 45.90  (11.40)
Month 9:bodily pain 42.24  (8.90) 44.17  (9.45) 43.88  (8.56) 47.17  (9.99)
Month 9:mental health 45.02  (11.18) 45.05  (11.75) 44.52  (11.29) 48.35  (11.68)
Month 9:role emotional 41.66  (12.56) 43.01  (11.72) 41.85  (11.43) 45.28  (11.54)
Month 9:vitality 47.50  (10.28) 47.94  (9.81) 46.23  (10.02) 50.10  (9.83)
Month 9:general health 40.61  (9.16) 42.02  (9.57) 40.79  (8.64) 43.98  (9.96)
Month 9:mental component 46.53  (11.50) 46.38  (11.16) 45.70  (11.01) 49.07  (10.98)
Month 9:physical component 39.79  (8.38) 42.49  (8.75) 40.52  (8.47) 43.44  (10.11)
Month 12:physical functioning 38.42  (10.83) 40.01  (11.03) 39.43  (10.51) 42.27  (11.02)
Month 12:role physical 41.37  (10.19) 43.59  (9.93) 42.31  (10.62) 45.15  (10.12)
Month 12:social functioning 43.48  (10.56) 45.18  (10.54) 44.28  (10.48) 47.18  (10.29)
Month 12:bodily pain 42.83  (8.85) 44.18  (9.59) 43.60  (8.21) 45.78  (9.89)
Month 12:mental health 44.73  (10.78) 45.07  (11.22) 44.66  (12.07) 46.81  (11.48)
Month 12:role emotional 41.09  (12.73) 42.80  (11.44) 41.27  (12.59) 44.38  (12.34)
Month 12:vitality 47.54  (10.15) 48.12  (9.96) 47.08  (11.04) 49.20  (10.33)
Month 12:general health 40.35  (9.31) 41.65  (9.38) 40.48  (9.38) 43.83  (9.53)
Month 12:mental component 45.82  (11.23) 46.49  (10.61) 45.55  (12.12) 47.95  (10.79)
Month 12:physical component 40.23  (8.61) 42.02  (8.82) 41.22  (8.29) 43.92  (9.20)
29.Secondary Outcome
Title Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Hide Description Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes 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(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 314 309 156
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline:overall sleep problem(n=314,309,156) 40.19  (20.12) 39.70  (19.48) 37.30  (18.32)
Baseline:sleep problem summary(n=314,309,156) 38.65  (20.70) 38.47  (19.62) 36.39  (18.50)
Baseline:somnolence(n=314,309,156) 36.75  (22.74) 34.63  (22.05) 33.72  (21.13)
Baseline:snoring(n=312,309,156) 34.36  (32.74) 29.71  (31.28) 29.36  (27.02)
Baseline:quantity(n=315,308,155) 6.46  (1.44) 6.42  (1.41) 6.46  (1.39)
Baseline:sleep disturbance(n=314,309,156) 41.04  (27.04) 40.60  (26.64) 36.49  (26.76)
Baseline:awaken short of breath(n=314,309,156) 17.90  (25.82) 15.15  (23.60) 14.74  (21.80)
Baseline:adequacy(n=314,309,156) 46.66  (28.23) 45.83  (27.37) 46.92  (26.14)
Month 1:overall sleep problem(n=307,307,151) 34.74  (20.68) 33.90  (18.55) 35.80  (19.12)
Month 1:sleep problem summary(n=307,307,151) 33.55  (20.86) 33.33  (18.97) 35.36  (19.46)
Month 1:somnolence(n=307,307,151) 32.18  (21.27) 30.38  (20.22) 32.80  (23.78)
Month 1:snoring(n=308,306,151) 31.36  (31.13) 30.20  (31.25) 29.80  (28.92)
Month 1:quantity(n=307,306,153) 6.60  (1.51) 6.69  (1.31) 6.38  (1.46)
Month 1:sleep disturbance(n=308,307,151) 34.04  (27.26) 33.07  (24.86) 33.73  (26.06)
Month 1:awaken short of breath(n=308,307,151) 15.26  (24.95) 11.60  (19.70) 14.97  (23.80)
Month 1:adequacy(n=308,307,151) 51.23  (28.31) 49.61  (27.28) 47.48  (26.79)
Month 3:overall sleep problem(n=295,300,146) 34.67  (20.37) 34.10  (19.56) 35.45  (18.16)
Month 3:sleep problem summary(n=295,300,146) 33.49  (20.90) 33.30  (19.97) 35.16  (19.04)
Month 3:somnolence(n=295,300,146) 31.86  (21.52) 28.64  (20.43) 32.65  (22.57)
Month 3:snoring(n=295,299,146) 33.49  (31.36) 28.90  (29.81) 30.27  (30.01)
Month 3:quantity(n=295,300,146) 6.69  (1.51) 6.67  (1.34) 6.59  (1.43)
Month 3:sleep disturbance(n=295,300,146) 34.43  (26.15) 34.32  (26.81) 33.15  (25.49)
Month 3:awaken short of breath(n=295,300,146) 16.61  (24.68) 14.13  (21.52) 15.75  (22.56)
Month 3:adequacy(n=295,300,146) 52.88  (29.21) 50.93  (27.31) 48.84  (25.74)
Month 6:overall sleep problem(n=282,285,62) 33.10  (19.14) 32.67  (18.56) 32.40  (13.97)
Month 6:sleep problem summary(n=282,285,62) 32.67  (20.38) 32.07  (18.84) 31.56  (15.05)
Month 6:somnolence(n=283,285,62) 30.60  (21.25) 28.16  (20.17) 27.74  (18.31)
Month 6:snoring(n=283,285,62) 31.87  (29.85) 31.51  (30.29) 29.03  (29.12)
Month 6:quantity(n=283,285,62) 6.66  (1.46) 6.66  (1.41) 6.65  (1.32)
Month 6:sleep disturbance(n=282,285,62) 31.76  (23.72) 32.10  (24.14) 31.61  (21.56)
Month 6:awaken short of breath(n=283,285,62) 15.90  (25.21) 13.47  (21.19) 13.23  (20.47)
Month 6:adequacy(n=283,285,62) 53.14  (27.54) 52.32  (26.99) 51.77  (26.64)
30.Secondary Outcome
Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Hide Description MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 315 309 156
Measure Type: Number
Unit of Measure: participants
Baseline (n=315,309,156) 140 132 70
Month 1 (n=309,309,153) 144 156 67
Month 3 (n=295,300,146) 140 150 71
Month 6 (n=283,285,139) 132 140 64
31.Secondary Outcome
Title Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24
Hide Description Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes 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(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
Time Frame Month 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 248 264 67 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 12:overall sleep problem 32.50  (18.21) 32.68  (19.05) 30.92  (17.24) 28.34  (17.87)
Month 12:sleep problem summary 31.69  (18.69) 31.97  (19.21) 31.69  (18.18) 28.73  (17.96)
Month 12:somnolence 30.53  (20.71) 29.75  (21.78) 28.96  (20.81) 25.40  (18.62)
Month 12:snoring 31.77  (30.75) 30.91  (31.14) 31.64  (30.18) 25.71  (25.25)
Month 12:quantity 6.73  (1.20) 6.67  (1.26) 6.73  (1.46) 6.71  (1.52)
Month 12:sleep disturbance 30.72  (23.45) 31.43  (24.09) 29.35  (23.07) 24.01  (24.02)
Month 12:awaken short of breath 14.19  (22.23) 13.48  (20.86) 15.82  (20.16) 13.33  (22.14)
Month 12:adequacy 53.35  (27.11) 52.16  (26.33) 55.37  (25.66) 53.02  (28.77)
32.Secondary Outcome
Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24
Hide Description MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time Frame Month 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 251 265 67 63
Measure Type: Number
Unit of Measure: participants
131 134 36 28
33.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 315 307 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=315,307,155) 28.59  (10.62) 29.49  (10.62) 31.07  (11.06)
Month 1 (n=309,306,150) 33.13  (10.47) 34.31  (10.19) 31.52  (10.63)
Month 3 (n=295,300,146) 34.19  (10.29) 36.14  (9.53) 31.51  (11.10)
Month 6 (n=283,284,61) 34.36  (9.95) 36.47  (9.76) 33.69  (9.06)
34.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24
Hide 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 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 250 265 67 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.06  (10.00) 35.88  (10.04) 35.58  (10.65) 37.29  (9.98)
35.Secondary Outcome
Title Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6
Hide 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, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 313 309 153
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=313,309,153) 0.43  (0.31) 0.47  (0.31) 0.47  (0.30)
Month 3 (n=261,262,125) 0.60  (0.27) 0.67  (0.22) 0.52  (0.30)
Month 6 (n=283,285,62) 0.62  (0.25) 0.69  (0.23) 0.59  (0.24)
36.Secondary Outcome
Title Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame Month 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 251 265 67 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.64  (0.25) 0.69  (0.26) 0.63  (0.30) 0.74  (0.22)
37.Secondary Outcome
Title Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
Hide 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, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 155 157 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline:time management(n=147,146,81) 49.74  (25.59) 41.93  (26.90) 44.02  (28.39)
Baseline:physical demands(n=149,152,86) 50.17  (24.18) 50.11  (24.19) 49.96  (26.67)
Baseline:mental demands(n=151,151,86) 33.91  (25.41) 29.28  (24.47) 33.13  (27.93)
Baseline:output demands(n=149,147,83) 38.81  (26.66) 36.85  (25.95) 40.57  (29.38)
Baseline:work loss index(n=155,157,87) 11.13  (5.71) 9.98  (5.66) 10.99  (6.78)
Month 3:time management(n=107,116,52) 45.18  (31.06) 35.87  (33.78) 41.11  (27.36)
Month 3:physical demands(n=106,124,55) 47.11  (29.37) 44.06  (32.26) 46.02  (25.36)
Month 3:mental demands(n=111,124,55 27.92  (27.18) 23.52  (27.09) 34.24  (27.87)
Month 3:output demands(n=108,119,54) 32.71  (27.67) 25.48  (28.69) 39.23  (28.44)
Month 3:work loss index(n=111,127,55) 9.77  (6.29) 7.86  (6.44) 10.89  (6.40)
Month 6:time management(n=97,116,19) 37.90  (30.57) 34.33  (33.47) 40.53  (32.70)
Month 6:physical demands(n=104,116,19) 48.00  (29.47) 43.01  (34.57) 43.90  (31.26)
Month 6:mental demands(n=103,117,18) 25.30  (29.75) 21.95  (28.40) 32.43  (30.69)
Month 6:output demands(n=101,117,18) 29.43  (29.61) 24.26  (29.30) 35.56  (26.78)
Month 6:work loss index(n=105,123,19) 8.78  (6.75) 7.47  (6.57) 10.05  (6.54)
38.Secondary Outcome
Title Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24
Hide 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 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 94 118 23 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 12:time management(n=92,108,22,32) 35.82  (31.75) 31.30  (31.68) 43.69  (32.76) 37.58  (36.88)
Month 12:physical demands(n=91,110,22,33) 45.64  (33.67) 46.16  (33.53) 47.01  (32.96) 41.10  (35.89)
Month 12:mental demands(n=93,115,23,33) 21.24  (25.05) 20.42  (25.99) 39.29  (35.39) 27.70  (33.57)
Month 12:output demands(n=93,107,23,31) 23.71  (26.59) 21.18  (26.52) 37.12  (34.59) 33.67  (34.78)
Month 12:work loss index(n=94,118,23,33) 7.78  (5.94) 6.88  (5.98) 11.33  (7.64) 9.24  (7.91)
39.Secondary Outcome
Title Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Hide 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 or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time Frame Baseline, Month 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 315 306 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Seen any doctor (n=315, 305, 154) 1.14  (0.34) 1.15  (0.36) 1.16  (0.36)
Baseline:Treated in emergency room(n=315,306,155) 1.93  (0.26) 1.96  (0.19) 1.94  (0.23)
Baseline:Admitted for overnight stay (n=22,12,9) 0.27  (0.63) 0.25  (0.45) 0.00  (0.00)
Baseline:Hospitalization(n=315,306,155) 1.94  (0.23) 1.94  (0.24) 1.97  (0.18)
Baseline:Outpatient surgery(n=315,305,155) 1.97  (0.16) 1.96  (0.20) 1.97  (0.18)
Baseline:Non-study diagnostic test(n=315,306,155) 1.82  (0.39) 1.83  (0.37) 1.85  (0.36)
Baseline:In nursing home(n=315,306,155) 1.99  (0.10) 1.99  (0.10) 1.99  (0.11)
Baseline:Home healthcare services(n=315,306,154) 1.97  (0.16) 1.99  (0.10) 1.98  (0.14)
Baseline:Required aids/devices(n=315,306,155) 1.87  (0.34) 1.91  (0.29) 1.90  (0.30)
Baseline:Non-medical practitioner(n=315,306,155) 1.97  (0.18) 1.94  (0.23) 1.95  (0.21)
Baseline:Currently employed(n=314,306,155) 1.65  (0.48) 1.60  (0.49) 1.62  (0.49)
Baseline:Feel well enough to work(n=182,166,89) 1.87  (0.33) 1.86  (0.35) 1.82  (0.39)
Baseline:Unable to work due to RA(n=185,169,88) 1.37  (0.48) 1.37  (0.48) 1.32  (0.47)
Baseline:Lost job/retired early(n=184,169,86) 1.61  (0.49) 1.61  (0.49) 1.67  (0.47)
Baseline:Work disabled due to RA(n=186,168,88) 1.52  (0.50) 1.61  (0.49) 1.52  (0.50)
Baseline:Retired(n=193,171,92) 1.51  (0.50) 1.51  (0.50) 1.52  (0.50)
Baseline:Sick leave due to RA(n=236,236,123) 1.83  (0.38) 1.81  (0.39) 1.76  (0.43)
Baseline:Performed part time work(n=235,236,121) 1.87  (0.34) 1.87  (0.33) 1.90  (0.30)
Baseline:Performed paid work(n=235,235,122) 1.60  (0.49) 1.62  (0.49) 1.61  (0.49)
Baseline:Unable to do chores(n=312,302,152) 1.38  (0.48) 1.43  (0.50) 1.43  (0.50)
Baseline:Chores by housekeeper(n=315,305,155) 1.83  (0.37) 1.85  (0.36) 1.90  (0.30)
Baseline:Chores by family/friends(n=315,305,155) 1.49  (0.50) 1.50  (0.50) 1.53  (0.50)
Month 3:Seen any doctor(n=259,260,121) 1.31  (0.46) 1.31  (0.46) 1.28  (0.45)
Month 3:Treated in emergency room(n=259,260,121) 1.95  (0.23) 1.95  (0.22) 1.97  (0.18)
Month 3:Admitted for overnight stay (n=14,12,4) 0.64  (0.84) 0.08  (0.29) 0.00  (0.00)
Month 3:Hospitalization(n=259,260,121) 1.97  (0.18) 1.98  (0.12) 1.99  (0.09)
Month 3:Outpatient surgery(n=259,260,121) 1.97  (0.17) 1.98  (0.12) 1.99  (0.09)
Month 3:Non-study diagnostic test(n=259,260,121) 1.86  (0.35) 1.83  (0.37) 1.88  (0.32)
Month 3:In nursing home(n=259,260,121) 2.00  (0.00) 2.00  (0.06) 2.00  (0.00)
Month 3:Home healthcare services(n=257,260,121) 1.98  (0.14) 2.00  (0.06) 2.00  (0.00)
Month 3:Required aids/devices(n=259,260,121) 1.91  (0.29) 1.91  (0.29) 1.89  (0.31)
Month 3:Non-medical practitioner(n=259,260,121) 1.98  (0.14) 1.97  (0.17) 1.98  (0.16)
Month 3:Currently employed(n=259,260,121) 1.63  (0.48) 1.57  (0.50) 1.60  (0.49)
Month 3:Feel well enough to work(n=147,140,68) 1.78  (0.41) 1.73  (0.45) 1.82  (0.38)
Month 3:Unable to work due to RA(n=148,139,67) 1.44  (0.50) 1.50  (0.50) 1.39  (0.49)
Month 3:Lost job/retired early(n=148,139,67) 1.64  (0.48) 1.63  (0.49) 1.57  (0.50)
Month 3:Work disabled due to RA(n=150,140,68) 1.53  (0.50) 1.64  (0.48) 1.57  (0.50)
Month 3:Retired(n=150,142,70) 1.51  (0.50) 1.42  (0.50) 1.63  (0.49)
Month 3:Sick leave due to RA(n=175,200,89) 1.89  (0.31) 1.93  (0.26) 1.82  (0.39)
Month 3:Performed part time work(n=176,196,89) 1.91  (0.29) 1.94  (0.24) 1.87  (0.34)
Month 3:Performed paid work(n=174,197,88) 1.70  (0.46) 1.76  (0.43) 1.69  (0.46)
Month 3:Unable to do chores(n=257,256,121) 1.60  (0.49) 1.70  (0.46) 1.52  (0.50)
Month 3:Chores by housekeeper(n=257,259,121) 1.90  (0.30) 1.92  (0.27) 1.90  (0.30)
Month 3:Chores by family/friends(n=257,259,121) 1.67  (0.47) 1.73  (0.44) 1.53  (0.50)
Month 6:Seen any doctor(n=282,285,61) 1.21  (0.41) 1.21  (0.41) 1.31  (0.47)
Month 6:Treated in emergency room(n=283,285,61) 1.94  (0.23) 1.96  (0.20) 1.93  (0.25)
Month 6:Admitted for overnight stay (n=17,12,4) 0.12  (0.33) 0.00  (0.00) 1.00  (0.15)
Month 6:Hospitalization(n=283,285,61) 1.99  (0.10) 1.99  (0.10) 1.93  (0.25)
Month 6:Outpatient surgery(n=283,285,61) 1.96  (0.20) 1.99  (0.10) 1.95  (0.22)
Month 6:Non-study diagnostic test(n=282,284,61) 1.79  (0.41) 1.85  (0.36) 1.82  (0.39)
Month 6:In nursing home(n=283,285,61) 1.99  (0.10) 2.00  (0.00) 2.00  (0.00)
Month 6:Home healthcare services(n=282,284,61) 1.98  (0.13) 1.99  (0.08) 1.98  (0.13)
Month 6:Required aids/devices(n=283,285,61) 1.90  (0.30) 1.94  (0.24) 1.97  (0.18)
Month 6:Non-medical practitioner(n=283,285,61) 1.98  (0.14) 1.97  (0.17) 1.97  (0.18)
Month 6:Currently employed(n=283,285,61) 1.65  (0.48) 1.59  (0.49) 1.70  (0.46)
Month 6:Feel well enough to work(n=176,154,38) 1.77  (0.42) 1.73  (0.44) 1.79  (0.41)
Month 6:Unable to work due to RA(n=177,155,40) 1.47  (0.50) 1.55  (0.50) 1.43  (0.50)
Month 6:Lost job/retired early(n=173,158,38) 1.69  (0.46) 1.63  (0.49) 1.79  (0.41)
Month 6:Work disabled due to RA(n=174,154,38) 1.52  (0.50) 1.66  (0.48) 1.66  (0.48)
Month 6:Retired(n=178,157,41) 1.49  (0.50) 1.48  (0.50) 1.61  (0.49)
Month 6:Sick leave due to RA(n=195,216,37) 1.92  (0.27) 1.95  (0.22) 1.89  (0.31)
Month 6:Performed part time work(n=193,215,37) 1.96  (0.20) 1.94  (0.23) 1.92  (0.28)
Month 6:Performed paid work(n=193,216,37) 1.76  (0.43) 1.76  (0.43) 1.65  (0.48)
Month 6:Unable to do chores(n=281,284,61) 1.63  (0.48) 1.80  (0.40) 1.64  (0.48)
Month 6:Chores by housekeeper(n=281,285,61) 1.89  (0.31) 1.92  (0.28) 1.90  (0.30)
Month 6:Chores by family/friends(n=281,285,61) 1.70  (0.46) 1.76  (0.42) 1.75  (0.43)
40.Secondary Outcome
Title Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24
Hide 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 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 250 265 67 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 12:Seen any doctor(n=250,265,67,63) 1.21  (0.41) 1.18  (0.39) 1.16  (0.37) 1.17  (0.38)
Month 12:Treated in ER(n=250,265,67,63) 1.93  (0.26) 1.96  (0.20) 1.94  (0.24) 1.95  (0.21)
Month 12:Admitted for overnight stay(n=18,11,4,3) 0.17  (0.38) 0.18  (0.40) 0.25  (0.50) 0.33  (0.58)
Month 12:Hospitalization(n=250,265,67,63) 1.97  (0.18) 1.98  (0.12) 1.97  (0.17) 1.98  (0.13)
Month 12:Outpatient surgery(n=250,265,67,63) 1.95  (0.22) 1.98  (0.12) 1.99  (0.12) 1.98  (0.13)
Month 12:Diagnostic test(n=250,265,67,63) 1.79  (0.41) 1.81  (0.39) 1.87  (0.34) 1.86  (0.35)
Month 12:In nursing home(n=250,265,67,63) 1.99  (0.09) 2.00  (0.00) 2.00  (0.00) 2.00  (0.00)
Month 12:Home healthcare services(n=249,264,67,63) 1.99  (0.09) 2.00  (0.06) 2.00  (0.00) 2.00  (0.00)
Month 12:Required aids/devices(n=250,265,67,63) 1.90  (0.31) 1.94  (0.23) 1.94  (0.24) 1.98  (0.13)
Month 12:Non-medical practitioner(n=250,265,67,63) 1.98  (0.13) 1.98  (0.15) 1.94  (0.24) 1.98  (0.13)
Month 12:Currently employed(n=250,265,67,63) 1.62  (0.49) 1.57  (0.50) 1.66  (0.48) 1.51  (0.50)
Month 12:Feel well enough to work(n=151,141,41,29) 1.73  (0.45) 1.65  (0.48) 1.80  (0.40) 1.62  (0.49)
Month 12:Unable to work due to RA(n=150,141,41,29) 1.50  (0.50) 1.53  (0.50) 1.49  (0.51) 1.66  (0.48)
Month 12:Lost job/retired early(n=151,143,41,29) 1.73  (0.45) 1.69  (0.47) 1.68  (0.47) 1.83  (0.38)
Month 12:Work disabled due to RA(n=151,143,42,30) 1.60  (0.49) 1.66  (0.47) 1.57  (0.50) 1.77  (0.43)
Month 12:Retired(n=154,140,42,30) 1.51  (0.50) 1.44  (0.50) 1.52  (0.51) 1.57  (0.50)
Month 12:Sick leave due to RA(n=168,200,46,48) 1.93  (0.25) 1.93  (0.26) 1.98  (0.15) 1.90  (0.31)
Month 12:Performed part time work(n=167,199,46,48) 1.99  (0.11) 1.96  (0.18) 2.00  (0.00) 1.94  (0.24)
Month 12:Performed paid work(n=168,200,46,48) 1.77  (0.42) 1.81  (0.39) 1.78  (0.42) 1.75  (0.44)
Month 12:Unable to do chores(n=246,265,67,63) 1.65  (0.48) 1.78  (0.42) 1.82  (0.39) 1.75  (0.44)
Month 12:Chores by housekeeper(n=249,264,67,63) 1.92  (0.27) 1.93  (0.25) 1.94  (0.24) 2.00  (0.00)
Month 12:Chores by family/friends(n=249,264,67,63) 1.75  (0.44) 1.79  (0.41) 1.76  (0.43) 1.79  (0.41)
41.Secondary Outcome
Title Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Hide Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame Baseline, Month 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 273 262 132
Mean (Standard Deviation)
Unit of Measure: events
Baseline:Doctor visit(n=273,262,132) 3.78  (4.24) 4.00  (5.07) 4.80  (5.61)
Baseline:RA related doctor visit(n=271,262,131) 1.16  (0.70) 1.20  (0.80) 1.25  (0.67)
Baseline:Hospital ER visit(n=19,11,9) 1.42  (0.77) 1.73  (1.27) 1.22  (0.67)
Baseline:RA related ER visit(n=23,12,9) 0.74  (0.81) 0.83  (1.34) 0.56  (0.73)
Baseline:Hospitalization(n=18,18,5) 1.17  (0.51) 1.17  (0.38) 1.00  (0.00)
Baseline:RA related hospitalization(n=18,19,5) 1.11  (0.58) 1.32  (1.34) 1.40  (0.55)
Baseline:Outpatient surgery(n=8,13,5) 1.13  (0.35) 1.85  (2.76) 1.00  (0.00)
Baseline:RA related outpatient surgery(n=8,14,5) 0.38  (0.52) 0.43  (0.85) 0.40  (0.55)
Baseline:Non-study diagnostic test(n=56,51,22) 1.80  (1.18) 1.67  (1.16) 1.73  (1.12)
Baseline:RA related diagnostic test(n=57,53,23) 0.74  (1.09) 0.77  (1.19) 0.83  (1.15)
Baseline:Non-medical practitioner visit(n=10,17,7) 12.50  (12.29) 10.88  (13.09) 12.57  (13.23)
Baseline:RA related non-medical visit(n=11,18,7) 1.00  (0.77) 1.00  (0.84) 1.57  (1.27)
Month 3:Doctor visit(n=181,181,89) 2.85  (1.79) 3.08  (2.76) 3.27  (3.73)
Month 3:RA related doctor visit(n=181,180,89) 0.92  (0.63) 0.79  (0.54) 0.87  (0.61)
Month 3:Hospital ER visit(n=14,11,4) 1.29  (0.61) 1.45  (0.93) 1.00  (0.00)
Month 3:RA related ER visit(n=14,13,4) 0.29  (0.73) 0.15  (0.55) 0.00  (0.00)
Month 3:Hospitalization(n=9,4,1) 1.00  (0.00) 1.25  (0.50) 2.00 [1]   (NA)
Month 3:RA related hospitalization(n=9,4,1) 0.11  (0.33) 0.00  (0.00) 0.00 [1]   (NA)
Month 3:Outpatient surgery(n=8,5,1) 1.25  (0.46) 1.20  (0.45) 1.00 [1]   (NA)
Month 3:RA related outpatient surgery(n=8,5,1) 0.00  (0.00) 0.00  (0.00) 0.00 [1]   (NA)
Month 3:Non-study diagnostic test(n=32,43,13) 1.41  (0.71) 1.56  (1.35) 1.46  (0.97)
Month 3:RA related diagnostic test(n=37,44,14) 0.14  (0.35) 0.07  (0.25) 0.14  (0.36)
Month 3:Non-medical practitioner visit(n=4,8,3) 7.50  (11.03) 3.63  (1.51) 22.33  (11.24)
Month 3:RA related non-medical visit(n=4,8,3) 0.50  (1.00) 0.38  (0.52) 0.67  (0.58)
Month 6:Doctor visit(n=226,225,43) 3.00  (2.89) 2.72  (2.28) 4.51  (6.05)
Month 6:RA related doctor visit(n=225,224,43) 0.87  (0.56) 0.86  (0.56) 0.91  (0.61)
Month 6:Hospital ER visit(n=15,12,4) 1.27  (0.59) 1.33  (0.49) 2.25  (2.50)
Month 6:RA related ER visit(n=16,12,4) 0.25  (0.58) 0.33  (0.78) 0.50  (1.00)
Month 6:Hospitalization(n=3,3,4) 1.00  (0.00) 1.00  (0.00) 1.25  (0.50)
Month 6:RA related hospitalization(n=3,3,4) 0.33  (0.58) 0.33  (0.58) 0.50  (1.00)
Month 6:Outpatient surgery(n=12,2,3) 1.33  (0.89) 1.00  (0.00) 1.00  (0.00)
Month 6:RA related outpatient surgery(n=12,3,3) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
Month 6:Non-study diagnostic test(n=58,41,11) 1.78  (1.83) 1.73  (1.40) 2.00  (1.00)
Month 6:RA related diagnostic test(n=60,44,11) 0.25  (0.68) 0.25  (0.69) 0.09  (0.30)
Month 6:Non-medical practitioner visit(n=6,8,2) 15.00  (17.34) 6.13  (4.55) 25.00  (7.07)
Month 6:RA related non-medical visit(n=6,8,3) 1.50  (1.52) 0.25  (0.46) 1.67  (0.58)
[1]
Standard deviation was not estimable as only 1 participant was evaluable.
42.Secondary Outcome
Title Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24
Hide Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame Month 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 197 221 56 52
Mean (Standard Deviation)
Unit of Measure: events
Month 12:Doctor visit(n=197,221,56,52) 2.70  (2.74) 2.43  (2.26) 3.27  (4.02) 2.81  (3.91)
Month 12:RA related doctor visit (n=197,220,56,52) 0.92  (0.52) 0.89  (0.43) 0.93  (0.60) 0.88  (0.47)
Month 12:Hospital ER visit(n=18,11,4,3) 1.61  (1.58) 1.00  (0.00) 1.25  (0.50) 1.00  (0.00)
Month 12:RA related ER visit(n=18,11,4,3) 0.11  (0.32) 0.09  (0.30) 0.25  (0.50) 0.00  (0.00)
Month 12:Hospitalization(n=8,4,2,1) 1.00  (0.00) 1.00  (0.00) 1.50  (0.71) 1.00  (0.00)
Month 12:RA related hospitalization(n=8,4,2,1) 0.50  (0.76) 0.50  (0.58) 0.00  (0.00) 0.00 [1]   (NA)
Month 12:Outpatient surgery(n=13,4,1,1) 2.31  (2.39) 1.00  (0.00) 1.00 [1]   (NA) 2.00 [1]   (NA)
Month 12:RA related outpatient surgery(n=13,4,1,1) 0.46  (0.66) 0.25  (0.50) 2.00 [1]   (NA) 0.00 [1]   (NA)
Month 12:Non-study diagnostic test(n=50,47,9,8) 1.98  (1.49) 1.55  (1.14) 2.00  (1.00) 1.88  (0.83)
Month 12:RA related diagnostic test(n=52,50,9,9) 0.27  (0.56) 0.24  (0.48) 0.22  (0.67) 0.11  (0.33)
Month 12:Non-medical practitioner visit(n=4,6,4,1) 12.00  (5.86) 9.83  (15.03) 10.00  (7.12) 9.00 [1]   (NA)
Month 12:RA related non-medical visit(n=4,6,4,1) 1.25  (0.96) 0.17  (0.41) 0.75  (0.96) 0.00 [1]   (NA)
[1]
Standard deviation was not estimable as only 1 participant was evaluable.
43.Secondary Outcome
Title Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 158 152 73
Mean (Standard Deviation)
Unit of Measure: days
Baseline:Hospital length of stay(n=18,18,5) 10.94  (9.12) 20.22  (19.70) 22.20  (15.37)
Baseline:Days in nursing home(n=3,3,2) 14.33  (12.10) 17.67  (3.51) 15.50  (7.78)
Baseline:Days aids/devices used(n=41,25,14) 109.63  (108.88) 74.08  (66.11) 102.21  (75.87)
Baseline:RA related aids used(n=42,29,14) 1.93  (1.24) 1.59  (1.02) 1.64  (0.50)
Baseline:Days of work per week(n=109,121,59) 5.01  (1.14) 5.14  (0.92) 4.93  (1.39)
Baseline:Days on sick leave due to RA(n=41,44,29) 13.17  (21.61) 16.84  (27.67) 15.45  (25.69)
Baseline:Days of part time work(n=30,29,12) 9.07  (12.62) 12.07  (16.50) 26.92  (32.20)
Baseline:Paid work, bothered by RA(n=92,88,48) 29.13  (30.81) 31.59  (30.12) 31.90  (31.61)
Baseline:Chores by housekeeper(n=50,44,15) 19.06  (23.91) 20.89  (33.69) 17.87  (18.71)
Baseline:Chores by family(n=158,152,73) 36.28  (34.40) 30.39  (34.00) 37.11  (34.99)
Month 3:Hospital length of stay(n=9,4,1) 5.67  (4.95) 16.25  (26.51) 32.00 [1]   (NA)
Month 3:Days in nursing home(n=0,1,0) NA [2]   (NA) 28.00 [1]   (NA) NA [2]   (NA)
Month 3:Days aids/devices used(n=23,22,13) 107.22  (102.77) 69.36  (60.36) 85.00  (57.64)
Month 3:RA related aids used(n=23,24,14) 1.78  (1.04) 1.21  (0.51) 1.21  (0.70)
Month 3:Days of work per week(n=97,113,48) 5.03  (1.03) 5.25  (0.92) 4.88  (1.21)
Month 3:Days on sick leave due to RA(n=19,15,16) 12.16  (20.51) 8.20  (19.95) 11.13  (21.56)
Month 3:Days of part time work(n=16,12,12) 9.44  (11.51) 9.42  (13.17) 15.67  (26.60)
Month 3:Paid work, bothered by RA(n=52,48,27) 20.60  (27.99) 17.42  (21.52) 34.59  (33.28)
Month 3:Chores by housekeeper(n=25,21,12) 17.00  (20.88) 6.05  (33.69) 21.75  (18.71)
Month 3:Chores by family(n=84,70,57) 31.37  (34.32) 21.46  (29.48) 27.53  (33.51)
Month 6:Hospital length of stay(n=3,3,4) 12.67  (9.07) 8.33  (6.66) 9.25  (2.50)
Month 6:Days in nursing home(n=3,0,0) 24.00  (3.61) NA [2]   (NA) NA [2]   (NA)
Month 6:Days aids/devices used(n=27,17,2) 93.44  (104.39) 87.12  (61.54) 110.00  (98.99)
Month 6:RA related aids used(n=28,18,2) 1.36  (1.06) 1.56  (1.20) 2.00  (0.00)
Month 6:Days of work per week(n=98,117,18) 5.02  (1.16) 5.29  (0.78) 4.94  (1.00)
Month 6:Days on sick leave due to RA(n=15,11,4) 14.93  (24.05) 14.18  (25.86) 24.25  (43.84)
Month 6:Days of part time work(n=8,12,3) 11.88  (14.99) 11.33  (11.44) 4.33  (1.15)
Month 6:Paid work, bothered by RA(n=46,52,13) 18.87  (25.75) 18.67  (19.85) 12.85  (15.66)
Month 6:Chores by housekeeper(n=30,24,6) 15.90  (22.43) 18.08  (26.29) 44.00  (40.99)
Month 6:Chores by family(n=85,66,15) 29.41  (33.22) 29.65  (33.02) 34.87  (40.65)
[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.
44.Secondary Outcome
Title Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24
Hide Description RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame Month 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 94 114 23 31
Mean (Standard Deviation)
Unit of Measure: days
Month 12:Hospital length of stay(n=8,4,2,1) 10.13  (6.58) 7.00  (5.35) 2.50  (2.12) 3.00 [1]   (NA)
Month 12:Days in nursing home(n=2,0,0,0) 11.50  (2.12) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Month 12:Days aids/devices used(n=25,14,4,1) 85.68  (95.83) 138.21  (110.42) 100.50  (57.63) 180.00 [1]   (NA)
Month 12:RA related aids used(n=26,16,4,1) 1.62  (1.06) 1.94  (1.69) 1.00  (0.82) 2.00 [1]   (NA)
Month 12:Days of work per week(n=94,114,23,31) 5.01  (1.15) 5.20  (0.75) 4.65  (1.15) 4.87  (1.26)
Month 12:Days on sick leave due to RA(n=11,15,1,5) 32.27  (39.24) 5.13  (4.42) 1.00 [1]   (NA) 5.60  (4.51)
Month 12:Days of part time work(n=3,7,0,3) 16.33  (17.90) 15.57  (21.19) NA [2]   (NA) 31.67  (51.39)
Month 12:Paid work, bothered by RA(n=38,38,10,12) 20.89  (24.78) 18.58  (24.28) 23.80  (28.35) 28.17  (35.51)
Month 12:Chores by housekeeper(n=18,18,4,0) 14.06  (20.23) 10.11  (11.20) 24.50  (43.68) NA [2]   (NA)
Month 12:Chores by family(n=62,56,16,13) 30.15  (33.03) 23.77  (31.80) 38.38  (39.32) 16.77  (24.59)
[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.
45.Secondary Outcome
Title Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 158 152 71
Mean (Standard Deviation)
Unit of Measure: hours per day
Baseline:Home healthcare services(n=6,2,3) 1.50  (0.84) 3.00  (1.41) 1.33  (0.58)
Baseline:RA related home HC services(n=8,4,3) 1.00  (0.76) 1.50  (1.00) 0.67  (1.15)
Baseline:Work done(n=108,121,59) 8.01  (4.05) 8.22  (4.41) 8.12  (5.25)
Baseline:Missed work due to RA(n=30,30,12) 7.03  (9.98) 5.33  (4.47) 4.33  (6.29)
Baseline:Chores by housekeeper(n=51,44,14) 4.27  (2.19) 4.98  (2.76) 4.21  (2.22)
Baseline:Chores by family(n=158,152,71) 3.95  (4.33) 3.66  (3.87) 3.49  (4.16)
Month 3:Home healthcare services(n=5,1,0) 1.20  (0.45) 4.00 [1]   (NA) NA [2]   (NA)
Month 3:RA related home HC services(n=5,1,0) 0.80  (0.84) 3.00 [1]   (NA) NA [2]   (NA)
Month 3:Work done(n=97,113,48) 7.71  (4.83) 8.25  (3.60) 7.42  (2.47)
Month 3:Missed work due to RA(n=16,12,12) 9.94  (16.85) 3.17  (2.92) 5.42  (6.16)
Month 3:Chores by housekeeper(n=25,21,12) 4.84  (4.59) 4.48  (2.18) 4.83  (2.62)
Month 3:Chores by family(n=83,70,56) 4.31  (9.29) 3.64  (4.73) 4.04  (4.45)
Month 6:Home healthcare services(n=5,2,1) 2.20  (2.17) 3.00  (2.83) 1.00 [1]   (NA)
Month 6:RA related home HC services(n=5,2,1) 1.20  (0.84) 1.50  (2.12) 0.00 [1]   (NA)
Month 6:Work done(n=98,117,18) 8.15  (4.15) 7.90  (1.85) 7.56  (3.05)
Month 6:Missed work due to RA(n=8,12,3) 2.38  (1.60) 2.50  (1.62) 1.00  (1.73)
Month 6:Chores by housekeeper(n=30,23,6) 4.97  (3.00) 4.87  (2.32) 2.67  (1.21)
Month 6:Chores by family(n=83,67,15) 3.13  (2.39) 3.25  (4.09) 2.93  (1.79)
[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.
46.Secondary Outcome
Title Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24
Hide 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 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 95 114 23 31
Mean (Standard Deviation)
Unit of Measure: hours per day
Month 12:Home healthcare services(n=2,1,0,0) 20.50  (27.58) 4.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA)
Month 12:RA related home HC services(n=2,1,0,0) 0.50  (0.71) 3.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA)
Month 12:Work done(n=95,114,23,31) 7.78  (3.81) 7.92  (1.88) 7.48  (2.02) 8.03  (2.09)
Month 12:Missed work due to RA(n=3,7,0,3) 1.33  (1.15) 8.71  (12.42) NA [2]   (NA) 2.67  (1.53)
Month 12:Chores by housekeeper(n=17,17,4,0) 4.47  (2.27) 4.53  (1.70) 5.25  (3.40) NA [2]   (NA)
Month 12:Chores by family(n=62,56,16,13) 3.31  (2.36) 3.20  (2.16) 3.75  (2.38) 2.31  (0.95)
[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.
47.Secondary Outcome
Title Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 204 202 104
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=204,202,104) 5.29  (3.09) 4.88  (3.03) 4.68  (3.03)
Month 3 (n=151,176,81) 3.81  (3.11) 3.11  (2.67) 4.40  (2.87)
Month 6 (n=160,185,29) 3.73  (3.18) 2.99  (2.94) 3.41  (2.85)
48.Secondary Outcome
Title Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24
Hide 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 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 144 163 39 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.19  (3.13) 2.66  (2.80) 2.51  (2.54) 2.66  (2.72)
49.Other Pre-specified Outcome
Title Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response
Hide 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 HAQ); and CRP. Participants with sustained ACR20 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time Frame Baseline through Month 12, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 79 75
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 16.8 13.9 21.5 16.9
3 consecutive visits 13.0 14.2 27.8 28.6
4 consecutive visits 16.5 16.2 11.4 10.4
5 consecutive visits 18.7 33.7 7.6 3.9
50.Other Pre-specified Outcome
Title Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response
Hide Description ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time Frame Baseline through Month 12, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 79 77
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 12.0 16.5 21.5 19.5
3 consecutive visits 7.9 11.3 13.9 13.0
4 consecutive visits 8.2 12.3 0.0 2.6
5 consecutive visits 7.3 9.4 1.3 0.0
51.Other Pre-specified Outcome
Title Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response
Hide 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. Participants with sustained ACR70 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time Frame Baseline through Month 12, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 79 77
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 6.6 10.4 8.9 18.2
3 consecutive visits 4.1 6.8 5.1 2.6
4 consecutive visits 2.8 7.1 0.0 0.0
5 consecutive visits 1.3 2.3 0.0 0.0
52.Other Pre-specified Outcome
Title Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6
Hide 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. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time Frame Baseline through Month 12, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 79 75
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 13.0 12.6 19.0 18.2
3 consecutive visits 7.9 11.7 5.1 7.8
4 consecutive visits 5.7 13.3 3.8 0.0
5 consecutive visits 2.2 3.2 1.3 0.0
53.Other Pre-specified Outcome
Title Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6
Hide 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. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time Frame Baseline through Month 12, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 79 77
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 4.4 5.5 3.8 7.8
3 consecutive visits 1.0 3.6 1.3 1.3
4 consecutive visits 1.9 3.2 0.0 0.0
5 consecutive visits 0.0 1.0 0.0 0.0
54.Other Pre-specified Outcome
Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6
Hide Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =<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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 257 129
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 6.98 10.40 3.15
Month 3 13.96 25.29 3.88
Month 6 14.34 28.40 3.10
55.Other Pre-specified Outcome
Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24
Hide Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 257 65 64
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 18.87 33.46 10.77 12.50
Month 12 21.13 28.79 9.23 17.19
56.Other Pre-specified Outcome
Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6
Hide Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =<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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 257 129
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 1.55 2.80 0.00
Month 3 5.28 11.28 1.55
Month 6 7.17 15.95 1.55
57.Other Pre-specified Outcome
Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24
Hide Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 265 257 65 64
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 10.57 14.01 4.62 3.13
Month 12 9.81 14.40 3.08 7.81
58.Other Pre-specified Outcome
Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 308 154
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 23.62 31.49 6.58
Month 3 35.28 44.48 11.69
Month 6 37.86 50.97 10.39
59.Other Pre-specified Outcome
Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24
Hide Description DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 308 79 75
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 38.51 52.27 25.32 24.00
Month 12 40.13 51.95 24.05 24.00
60.Other Pre-specified Outcome
Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6
Hide 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 308 154
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 11.33 9.09 1.97
Month 3 20.39 26.95 5.19
Month 6 22.98 36.36 5.19
61.Other Pre-specified Outcome
Title Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24
Hide Description DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Month 9, 12, 15, 18, 21, 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo, Then CP-690,550 5 mg Placebo, Then CP-690,550 10 mg
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 309 308 79 75
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 26.86 38.31 22.78 14.67
Month 12 28.80 39.61 17.72 18.67
62.Other Pre-specified Outcome
Title Association Between Genomic and Metabonomic Variation
Hide Description [Not Specified]
Time Frame Month 24
Outcome Measure Data Not Reported
63.Other Pre-specified Outcome
Title Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6
Hide Description BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
CP-690,550 10 mg tablet orally twice daily up to Month 24.
Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
Overall Number of Participants Analyzed 316 309 156
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury (mmHg)