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Trial record 26 of 158 for:    Diseases | ( Map: Costa Rica )

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

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ClinicalTrials.gov Identifier: NCT00853385
Recruitment Status : Completed
First Posted : March 2, 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 Rheumatoid Arthritis
Interventions Drug: CP 690,550
Drug: CP-690,550
Other: Placebo
Biological: Biologic TNFi
Enrollment 717
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 Adalimumab
Hide Arm/Group Description CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Period Title: Overall Study
Started 204 201 56 52 204
Completed 150 158 47 39 162
Not Completed 54 43 9 13 42
Reason Not Completed
Death             0             0             0             0             1
Adverse Event             24             24             2             5             22
Lack of Efficacy             6             7             3             3             6
Lost to Follow-up             2             1             0             0             0
Withdrawal by Subject             4             2             0             1             1
Other             18             9             4             4             12
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 Adalimumab Total
Hide Arm/Group Description CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12. Total of all reporting groups
Overall Number of Baseline Participants 204 201 56 52 204 717
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 204 participants 201 participants 56 participants 52 participants 204 participants 717 participants
53.0  (11.9) 52.9  (11.8) 55.5  (13.7) 51.9  (13.7) 52.5  (11.7) 52.9  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants 201 participants 56 participants 52 participants 204 participants 717 participants
Female
174
  85.3%
168
  83.6%
43
  76.8%
39
  75.0%
162
  79.4%
586
  81.7%
Male
30
  14.7%
33
  16.4%
13
  23.2%
13
  25.0%
42
  20.6%
131
  18.3%
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% improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all randomized participants who received >=1 dose and had >=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 196 196 106 199
Measure Type: Number
Unit of Measure: percentage of participants
51.53 52.55 28.30 47.24
Show Statistical Analysis 1 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 CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (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. 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 24.24
Confidence Interval (2-Sided) 95%
13.18 to 35.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 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 CP-690,550 5 mg to placebo and 2-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. 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 23.22
Confidence Interval (2-Sided) 95%
12.16 to 34.29
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
Comments Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments Statistical testing was done at 5% significance level (2-sided).
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 18.93
Confidence Interval (2-Sided) 95%
7.90 to 29.96
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) 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; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 201 199 106 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=201, 199, 106, 201) 1.50  (0.64) 1.53  (0.63) 1.42  (0.68) 1.50  (0.59)
Month 3 (n=188, 185, 98, 190) -0.49  (0.59) -0.59  (0.58) -0.17  (0.56) -0.45  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg, Placebo
Comments Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
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 the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.50 to -0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg, Placebo
Comments LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.43 to -0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
Comments LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical testing was done at 5% significance level (2-sided).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.37 to -0.13
Estimation Comments [Not Specified]
3.Primary 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 6
Hide Description DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 177 176 92 178
Measure Type: Number
Unit of Measure: percentage of participants
6.21 12.50 1.09 6.74
Show Statistical Analysis 1 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 11.41
Confidence Interval (2-Sided) 95%
6.08 to 16.73
Estimation Comments [Not Specified]
Show Statistical Analysis 2 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 CP-690,550 5 mg to placebo and 2-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 0.0151
Comments Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 5.12
Confidence Interval (2-Sided) 95%
0.98 to 9.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
Comments Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments Statistical testing was done at 5% significance level (2-sided).
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 5.65
Confidence Interval (2-Sided) 95%
1.40 to 9.90
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
Hide Description ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Month 1, 3
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 196 196 106 199
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 41.24 45.92 16.04 37.88
Month 3 60.71 58.67 26.42 56.28
5.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
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 the HAQ); and CRP.
Time Frame Month 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 196 196 56 50 199
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 49.49 50.51 30.36 36.00 47.24
Month 12 49.49 49.49 33.93 34.00 49.25
6.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
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 the HAQ); and CRP.
Time Frame Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 196 196 106 199
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 14.95 16.33 4.72 12.12
Month 3 34.18 27.55 6.60 23.62
Month 6 36.73 34.69 12.26 27.64
7.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
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 the HAQ); and CRP.
Time Frame Month 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 196 196 56 50 199
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 35.71 37.24 17.86 26.00 29.15
Month 12 36.73 35.71 21.43 28.00 33.67
8.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response 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 the HAQ); and CRP.
Time Frame Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 196 196 106 199
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 2.58 4.08 0.94 3.03
Month 3 12.24 14.80 1.89 8.54
Month 6 19.90 21.94 1.89 9.05
9.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
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 the HAQ); and CRP.
Time Frame Month 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 196 196 56 50 199
Measure Type: Number
Unit of Measure: percentage of participants
Month 9 18.37 21.94 8.93 10.00 11.06
Month 12 22.96 23.47 10.71 14.00 16.58
10.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 (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 200 199 106 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=200, 199, 106, 201) 5.43  (0.89) 5.43  (0.83) 5.44  (0.88) 5.33  (0.92)
Month 1 (n=193, 196, 104, 197) 4.26  (1.09) 4.21  (1.05) 5.09  (1.15) 4.27  (1.06)
Month 3 (n=187, 184, 99, 190) 3.78  (1.21) 3.77  (1.21) 4.83  (1.25) 3.88  (1.15)
Month 6 (n=174, 180, 46, 181) 3.51  (1.27) 3.29  (1.22) 3.85  (1.14) 3.63  (1.19)
11.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 160 167 49 41 171
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 9 (n=160, 167, 49, 41, 171) 3.13  (1.11) 3.20  (1.20) 3.11  (1.11) 3.03  (1.10) 3.46  (1.21)
Month 12 (n=149, 150, 48, 37, 160) 3.05  (1.13) 3.00  (1.18) 3.12  (0.96) 3.02  (1.28) 3.18  (1.25)
12.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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 195 194 103 194
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=195, 194, 103, 194) 6.56  (0.93) 6.48  (0.89) 6.45  (0.90) 6.36  (0.93)
Month 1 (n=172, 175, 90, 176) 5.23  (1.19) 5.14  (1.26) 5.93  (1.22) 5.13  (1.21)
Month 3 (n=170, 166, 87, 167) 4.64  (1.33) 4.66  (1.39) 5.60  (1.31) 4.66  (1.28)
Month 6 (n=155, 162, 41, 158) 4.40  (1.38) 4.21  (1.38) 4.61  (1.17) 4.37  (1.30)
13.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12
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 Month 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 140 151 45 35 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 9 (n=140, 151, 45, 35, 149) 4.00  (1.21) 4.08  (1.33) 3.99  (1.25) 3.93  (1.17) 4.20  (1.39)
Month 12 (n=134, 136, 44, 32, 139) 3.85  (1.22) 3.88  (1.35) 4.00  (0.95) 3.70  (1.24) 3.95  (1.48)
14.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Hide Description DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.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 SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Month 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Health Assessment Questionnaire-Disability Index (HAQ-DI) at 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; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 194 196 106 198
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 (n=194, 196, 106, 198) 1.15  (0.66) 1.11  (0.67) 1.32  (0.69) 1.12  (0.64)
Month 3 (n=188, 185, 99, 190) 1.00  (0.72) 0.94  (0.75) 1.25  (0.67) 1.05  (0.64)
Month 6 (n=174, 181, 46, 180) 0.92  (0.72) 0.89  (0.69) 1.15  (0.71) 0.98  (0.65)
17.Secondary Outcome
Title Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
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; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame Month 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 158 167 49 41 171
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 9 (n=158, 167, 49, 41, 171) 0.86  (0.66) 0.85  (0.66) 0.89  (0.69) 0.90  (0.64) 0.97  (0.67)
Month 12 (n=149, 149, 49, 38, 159) 0.83  (0.68) 0.81  (0.71) 0.88  (0.71) 0.91  (0.72) 0.90  (0.67)
18.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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 201 199 106 201
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=201, 199, 106, 201) 59.29  (20.95) 59.01  (22.18) 55.20  (21.27) 56.46  (21.92)
Month 1 (n=194, 196, 106, 198) 39.71  (22.60) 36.77  (22.63) 49.92  (23.94) 39.27  (24.29)
Month 3 (n=188, 185, 99, 190) 32.98  (23.09) 31.27  (22.39) 48.53  (23.42) 36.27  (25.67)
Month 6 (n=174, 181, 46, 179) 30.40  (23.26) 28.36  (22.52) 35.04  (20.95) 32.78  (22.57)
19.Secondary Outcome
Title Patient Assessment of Arthritis Pain at Month 9 and 12
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Month 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 158 167 49 41 171
Mean (Standard Deviation)
Unit of Measure: mm
Month 9 (n=158, 167, 49, 41, 171) 27.04  (21.35) 27.99  (22.97) 31.31  (22.66) 24.93  (19.38) 32.70  (24.18)
Month 12 (n=150, 150, 49, 38, 160) 26.99  (21.97) 24.55  (20.68) 28.23  (17.86) 29.37  (20.57) 27.94  (22.70)
20.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 mm = very well and 100 mm = very poorly.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 201 199 106 201
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=201, 199, 106, 201) 59.86  (21.38) 56.55  (23.83) 54.46  (21.27) 57.22  (22.22)
Month 1 (n=194, 196, 105, 197) 41.85  (23.02) 36.61  (23.51) 50.70  (24.24) 39.32  (23.83)
Month 3 (n=188, 185, 99, 190) 35.56  (23.81) 31.25  (22.23) 49.84  (22.45) 36.97  (25.28)
Month 6 (n=174, 181, 46, 180) 32.79  (25.56) 29.74  (22.41) 37.76  (20.86) 33.50  (21.97)
21.Secondary Outcome
Title Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
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 mm = very well and 100 mm = very poorly.
Time Frame Month 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 158 167 49 41 171
Mean (Standard Deviation)
Unit of Measure: mm
Month 9 (n=158, 167, 49, 41, 171) 28.39  (22.31) 29.47  (21.99) 31.78  (20.75) 30.00  (20.31) 34.38  (24.93)
Month 12 (n=149, 150, 49, 37, 160) 26.86  (22.44) 27.70  (22.09) 30.78  (17.65) 29.70  (20.69) 30.33  (24.46)
22.Secondary Outcome
Title Physician Global Assessment (PGA) of Arthritis Pain 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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 199 199 106 201
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=199, 199, 106, 201) 59.92  (16.77) 59.56  (16.70) 60.28  (16.55) 58.64  (15.98)
Month 1 (n=193, 195, 106, 197) 38.90  (18.56) 36.16  (19.27) 50.73  (22.08) 38.81  (20.08)
Month 3 (n=186, 185, 99, 189) 30.28  (20.71) 29.91  (21.04) 45.12  (22.77) 32.40  (21.08)
Month 6 (n=174, 180, 46, 178) 24.97  (19.26) 24.46  (19.78) 29.76  (20.43) 27.77  (18.36)
23.Secondary Outcome
Title Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 160 167 49 41 170
Mean (Standard Deviation)
Unit of Measure: mm
Month 9 (n=160, 167, 49, 41, 170) 19.93  (16.20) 21.92  (17.87) 25.82  (20.32) 23.78  (15.54) 25.45  (19.94)
Month 12 (n=149, 150, 48, 38, 157) 18.67  (16.18) 18.87  (16.05) 19.77  (13.88) 20.68  (14.51) 20.44  (16.94)
24.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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 201 199 106 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Physical functioning (n=201,199,106,201) 32.02  (9.48) 31.06  (9.52) 32.23  (9.43) 31.74  (8.95)
Baseline: Role physical (n=201,199,106,201) 34.00  (9.11) 33.54  (9.12) 34.70  (8.01) 34.79  (8.69)
Baseline: Social functioning (n=201,199,106,201) 36.15  (10.76) 36.27  (11.59) 39.36  (11.17) 36.23  (11.52)
Baseline: Bodily pain (n=201,199,106,201) 33.42  (7.51) 33.29  (7.42) 34.53  (6.57) 33.14  (7.33)
Baseline: Mental health (n=201,199,106,201) 39.04  (11.42) 39.15  (11.19) 41.11  (10.51) 39.64  (11.19)
Baseline: Role emotional (n=201,199,106,201) 34.15  (12.49) 34.11  (12.63) 37.32  (11.97) 35.54  (12.05)
Baseline: Vitality (n=201,199,106,201) 40.62  (9.23) 40.79  (9.36) 42.67  (8.85) 39.95  (9.54)
Baseline: General health (n=201,199,106,201) 35.22  (8.95) 35.81  (8.93) 36.29  (8.38) 35.18  (7.96)
Baseline:Mental component (n=201,199,106,201) 39.82  (11.68) 40.21  (11.14) 43.29  (10.58) 40.58  (11.64)
Baseline: Physical component (n=201,199,106,201) 33.10  (7.69) 32.62  (7.78) 33.02  (6.23) 32.74  (6.83)
Month 1: Physical functioning (n=194,196,106,198) 35.29  (9.94) 35.23  (10.57) 34.00  (9.68) 35.38  (9.79)
Month 1: Role physical (n=194,196,106,198) 38.19  (9.34) 38.45  (10.01) 36.79  (9.39) 38.37  (9.06)
Month 1: Social functioning (n=194,196,106,198) 40.77  (10.53) 42.22  (10.64) 41.74  (10.72) 40.98  (10.41)
Month 1: Bodily pain (n=194,196,106,198) 40.14  (8.54) 40.73  (8.46) 36.18  (7.52) 39.58  (8.36)
Month 1: Mental health (n=194,196,106,198) 42.31  (10.30) 43.35  (11.13) 41.79  (10.91) 42.83  (10.93)
Month 1: Role emotional (n=194,196,106,198) 38.29  (12.54) 38.64  (12.05) 38.18  (11.89) 39.10  (11.55)
Month 1: Vitality (n=194,196,106,198) 45.24  (9.33) 46.99  (9.58) 43.71  (8.74) 44.44  (10.00)
Month 1: General health (n=194,196,106,198) 38.53  (9.24) 39.98  (9.16) 37.41  (8.61) 38.35  (8.43)
Month 1: Mental component (n=194,196,106,198) 43.56  (10.60) 44.92  (11.21) 44.03  (11.04) 44.05  (10.79)
Month 1: Physical component (n=194,196,106,198) 37.50  (7.99) 37.86  (8.11) 35.01  (7.36) 37.08  (7.88)
Month 3: Physical functioning (n=187,185,99,190) 38.11  (10.39) 38.49  (11.12) 34.77  (8.92) 36.56  (10.24)
Month 3: Role physical (n=188,185,99,190) 39.79  (9.55) 40.93  (10.40) 37.25  (8.88) 39.51  (8.89)
Month 3: Social functioning (n=188,185,99,190) 41.59  (11.04) 44.34  (11.00) 41.41  (10.08) 40.84  (10.92)
Month 3: Bodily pain (n=187,185,99,190) 41.08  (9.15) 43.09  (9.58) 37.05  (7.91) 40.60  (9.54)
Month 3: Mental health (n=188,185,99,190) 42.43  (11.02) 44.79  (11.25) 42.44  (10.04) 43.05  (10.45)
Month 3: Role emotional (n=188,185,99,190) 38.74  (12.56) 41.76  (12.66) 38.59  (12.42) 39.24  (11.53)
Month 3: Vitality (n=188,185,99,190) 45.63  (9.91) 48.09  (10.79) 44.06  (9.22) 45.57  (9.76)
Month 3: General health (n=188,185,99,189) 39.15  (9.52) 41.35  (8.93) 37.51  (8.08) 39.33  (9.32)
Month 3: Mental component (n=187,185,99,189) 43.31  (11.47) 46.49  (11.45) 44.20  (10.65) 43.90  (10.84)
Month 3: Physical component (n=187,185,99,189) 39.57  (8.76) 40.30  (8.94) 35.59  (7.33) 38.58  (8.36)
Month 6: Physical functioning (n=173,181,46,179) 39.31  (10.92) 38.56  (11.35) 37.00  (8.99) 37.29  (10.40)
Month 6: Role physical (n=173,181,46,179) 40.42  (10.03) 41.29  (9.73) 38.62  (7.95) 39.99  (9.14)
Month 6: Social functioning (n=173,181,46,180) 43.85  (11.17) 43.98  (11.30) 42.49  (9.92) 42.36  (10.43)
Month 6: Bodily pain (n=173,181,46,180) 42.79  (9.41) 43.63  (9.31) 39.79  (8.05) 41.59  (8.95)
Month 6: Mental health (n=173,181,46,180) 44.31  (11.29) 45.32  (11.43) 41.21  (11.70) 43.13  (11.35)
Month 6: Role emotional (n=173,181, 46,179) 40.78  (12.03) 40.68  (11.77) 39.22  (11.82) 39.54  (11.85)
Month 6: Vitality (n=173,181,46,180) 47.35  (10.37) 48.66  (10.08) 45.06  (9.36) 45.93  (9.88)
Month 6: General health (n=173,180,46,180) 40.53  (9.44) 41.95  (8.89) 39.03  (9.30) 39.91  (8.72)
Month 6: Mental component (n=173,180,46,179) 45.44  (11.19) 46.14  (11.43) 43.43  (10.60) 44.24  (11.69)
Month 6: Physical component (n=173,180,46,179) 40.45  (9.29) 40.86  (8.71) 38.44  (6.67) 39.36  (8.39)
25.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Time Frame Month 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 159 167 49 41 171
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 9: Physical functioning(n=158,167,49,41,171) 39.77  (10.29) 38.74  (11.31) 38.94  (9.81) 38.59  (10.08) 38.75  (10.23)
Month 9: Role physical (n=159,167,49,41,171) 41.66  (9.62) 40.55  (10.15) 41.77  (8.36) 39.75  (9.20) 41.12  (9.44)
Month 9: Social functioning (n=159,167,49,41,171) 43.52  (10.65) 44.42  (9.96) 44.55  (9.82) 42.76  (9.78) 42.03  (11.55)
Month 9: Bodily pain (n=159,166,49,41,171) 43.45  (9.02) 42.75  (9.50) 44.68  (8.86) 42.26  (7.77) 41.81  (9.73)
Month 9: Mental health (n=159,166,49,41,171) 44.47  (10.27) 45.42  (10.44) 44.83  (10.70) 43.70  (10.16) 43.44  (12.04)
Month 9: Role emotional (n=159,167,49,41,171) 39.98  (11.99) 40.58  (12.07) 39.84  (11.40) 41.46  (11.81) 40.07  (12.15)
Month 9: Vitality (n=159,166,49,41,171) 47.76  (9.51) 48.69  (9.68) 47.80  (8.94) 46.41  (10.03) 46.11  (10.28)
Month 9: General health (n=159,166,49,41,171) 41.15  (9.79) 41.34  (9.20) 41.39  (8.54) 40.57  (9.34) 40.12  (9.58)
Month9:Mental component (n=158,165,49,41,171) 44.79  (10.76) 46.55  (10.52) 45.31  (9.75) 45.23  (11.22) 44.08  (11.45)
Month 9: Physical component (n=158,165,49,41,171) 41.55  (8.57) 40.32  (9.44) 41.65  (8.20) 39.73  (7.73) 40.35  (8.31)
Month 12:Physical functioning(n=149,149,49,38,160) 40.16  (10.25) 40.34  (11.59) 39.24  (10.07) 40.42  (9.84) 39.21  (10.63)
Month 12: Role physical (n=150,150,49,38,160) 41.15  (9.35) 42.34  (10.32) 40.16  (8.73) 41.18  (9.30) 41.07  (9.29)
Month 12: Social functioning (n=150,150,49,38,160) 43.14  (10.46) 44.07  (10.44) 43.78  (9.97) 44.94  (9.78) 42.96  (10.92)
Month 12: Bodily pain (n=150,150,49,38,160) 43.44  (9.48) 44.02  (10.02) 43.90  (8.28) 43.18  (7.76) 42.73  (9.77)
Month 12: Mental health (n=150,149,49,38,159) 44.83  (10.02) 45.06  (10.49) 44.09  (9.20) 45.28  (10.94) 44.23  (10.93)
Month 12:Role emotional (n=150,150,49,38,159) 40.18  (11.46) 42.25  (11.68) 40.23  (10.79) 41.03  (12.67) 39.89  (11.63)
Month 12: Vitality (n=150,149,49,38,159) 47.60  (9.01) 49.12  (9.95) 47.31  (9.13) 48.17  (9.36) 46.27  (9.65)
Month 12:General health (n=150,150,49,38,160) 41.07  (9.85) 42.33  (9.05) 40.47  (9.44) 40.77  (8.31) 40.40  (9.13)
Month 12:Mental component (n=149,149,49,38,158) 45.02  (10.14) 46.29  (10.56) 45.02  (9.29) 46.12  (11.75) 44.42  (10.70)
Month 12: Physical component(n=149,149,49,38,158) 41.44  (8.81) 41.96  (9.40) 40.82  (8.01) 41.12  (6.49) 40.72  (8.84)
26.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
Hide Description FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 201 199 106 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=201, 199, 106, 201) 28.18  (10.48) 28.56  (10.84) 30.49  (10.23) 27.95  (10.07)
Month 1 (n=192, 196, 106, 198) 32.54  (9.94) 33.95  (10.54) 31.66  (10.09) 31.94  (10.48)
Month 3 (n=187, 185, 99, 190) 33.86  (10.18) 35.12  (11.07) 30.96  (10.21) 32.72  (10.27)
Month 6 (n=173, 181, 46, 180) 34.58  (10.53) 36.09  (10.07) 32.37  (8.92) 33.69  (10.58)
27.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
Hide Description FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 150 151 49 38 159
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.76  (9.53) 37.53  (10.41) 36.71  (7.81) 35.71  (9.65) 34.30  (9.83)
28.Secondary Outcome
Title Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Hide Description Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Month 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 199 198 105 200
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: SPS (n=199, 198, 105, 200) 42.13  (20.58) 40.20  (19.48) 39.14  (19.04) 40.90  (19.68)
Baseline: OSP (n=199, 198, 105, 200) 43.24  (19.91) 42.27  (19.32) 41.27  (19.47) 43.12  (19.50)
Baseline: Ade (n=200, 198, 105, 200) 42.95  (27.92) 44.04  (28.21) 47.43  (26.06) 44.25  (27.83)
Baseline: ASOB (n=200, 198, 105, 200) 19.10  (24.91) 15.96  (21.70) 18.67  (24.54) 20.00  (24.31)
Baseline: SD (n=200, 198, 105, 200) 45.46  (26.30) 44.67  (25.96) 43.95  (27.40) 46.55  (26.31)
Baseline: Qua (n=200, 198, 104, 199) 6.46  (1.36) 6.61  (1.70) 6.70  (1.51) 6.65  (1.82)
Baseline: Sno (n=198, 197, 105, 199) 36.06  (31.78) 34.62  (31.71) 30.10  (28.16) 34.77  (30.50)
Baseline: Som (n=199, 198, 105, 199) 36.52  (21.22) 35.66  (22.28) 36.70  (20.55) 33.47  (19.68)
Month 1: SPS (n=194, 195, 105, 198) 36.25  (19.19) 34.03  (18.74) 37.62  (18.83) 38.16  (20.30)
Month 1: OSP (n=194, 195, 105, 198) 36.70  (18.13) 34.81  (18.64) 38.77  (18.45) 39.18  (19.67)
Month 1: Ade (n=194, 195, 105, 198) 48.97  (27.11) 52.62  (27.62) 49.81  (25.87) 46.87  (27.30)
Month 1: ASOB (n=194, 195, 105, 198) 18.35  (22.52) 14.56  (20.13) 19.81  (23.78) 18.69  (25.26)
Month 1: SD (n=194, 195, 105, 198) 36.52  (23.48) 35.46  (24.25) 40.43  (26.13) 39.41  (25.42)
Month 1: Qua (n=193, 195, 105, 197) 6.70  (1.38) 6.97  (1.49) 6.74  (1.49) 6.89  (1.55)
Month 1: Sno (n=194, 193, 104, 196) 36.08  (32.53) 34.30  (29.56) 31.35  (27.13) 32.76  (28.19)
Month 1: Som (n=194, 195, 105, 198) 31.68  (21.26) 31.04  (22.02) 33.90  (21.80) 33.91  (19.60)
Month 3: SPS (n=186, 185, 99, 190) 35.39  (18.66) 32.86  (20.91) 37.54  (19.18) 37.21  (20.47)
Month 3: OSP (n=186, 185, 99, 190) 35.74  (18.30) 33.44  (20.23) 38.55  (18.97) 38.32  (20.05)
Month 3: Ade (n=187, 185, 99, 190) 50.59  (27.67) 53.24  (28.90) 48.99  (28.16) 49.21  (28.65)
Month 3: ASOB (n=187, 185, 99, 190) 18.18  (22.12) 14.81  (20.62) 18.59  (20.85) 18.42  (24.42)
Month 3: SD (n=186, 185, 99, 190) 35.93  (24.29) 32.86  (25.10) 38.66  (26.24) 39.95  (25.83)
Month 3: Qua (n=188, 185, 99, 190) 6.82  (1.32) 7.03  (1.45) 6.51  (1.56) 6.83  (1.47)
Month 3: Sno (n=186, 184, 99, 189) 33.66  (30.78) 34.35  (30.06) 30.10  (22.92) 34.60  (27.80)
Month 3: Som (n=187, 185, 99, 190) 29.41  (19.66) 30.74  (22.65) 36.50  (20.10) 31.05  (20.26)
Month 6: SPS (n=173, 181, 46, 179) 32.66  (18.60) 31.79  (18.64) 36.52  (19.89) 36.31  (19.25)
Month 6: OSP (n=173, 181, 46, 179) 33.28  (17.93) 32.46  (18.50) 36.87  (18.51) 36.73  (19.04)
Month 6: Ade (n=173, 181, 46, 179) 53.12  (28.85) 53.76  (27.87) 50.00  (26.83) 50.22  (27.33)
Month 6: ASOB (n=173, 181, 46, 179) 16.65  (22.00) 13.48  (20.21) 16.52  (20.79) 19.22  (22.37)
Month 6: SD (n=173, 181, 46, 179) 32.95  (23.76) 32.00  (24.30) 37.31  (24.73) 36.39  (24.20)
Month 6: Qua (n=173, 181, 45, 178) 6.86  (1.18) 7.10  (1.60) 6.71  (1.50) 6.81  (1.36)
Month 6: Sno (n=171, 180, 46, 179) 31.46  (31.43) 35.00  (29.13) 23.91  (23.33) 33.18  (27.32)
Month 6: Som (n=173, 181, 46, 179) 28.17  (17.55) 30.39  (22.37) 33.62  (17.72) 31.84  (20.38)
29.Secondary Outcome
Title Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Hide Description Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 148 150 49 37 158
Mean (Standard Deviation)
Unit of Measure: units on a scale
SPS (n=148, 150, 49, 37, 159) 34.62  (18.58) 30.64  (18.42) 34.69  (19.10) 34.68  (21.32) 35.72  (20.25)
OSP (n=148, 150, 49, 37, 158) 34.86  (17.87) 31.49  (17.90) 36.00  (17.63) 35.38  (20.40) 36.52  (19.68)
Ade (n=149, 150, 49, 37, 159) 51.21  (26.96) 57.20  (28.48) 54.29  (27.84) 50.00  (30.18) 49.81  (27.20)
ASOB (n=149, 150, 49, 37, 159) 16.78  (19.74) 14.13  (20.67) 21.22  (22.14) 18.38  (18.49) 17.48  (21.79)
SD (n=149, 150, 49, 37, 159) 34.82  (23.95) 32.32  (22.41) 37.12  (23.55) 34.86  (23.94) 37.36  (25.19)
Qua (n=148, 150, 49, 37, 158) 6.78  (1.19) 7.03  (1.47) 6.86  (1.34) 6.84  (1.34) 6.72  (1.31)
Sno (n=148, 150, 48, 37, 159) 33.78  (29.95) 30.53  (27.29) 27.50  (22.83) 32.43  (26.81) 34.47  (30.01)
Som (n=148, 150, 49, 37, 158) 29.41  (18.95) 27.07  (19.36) 32.38  (17.53) 29.37  (22.25) 30.00  (21.21)
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 201 199 106 201
Measure Type: Number
Unit of Measure: participants
Baseline (n=201, 199, 106, 201) 94 94 49 88
Month 1 (n=194, 196, 106, 198) 93 107 55 95
Month 3 (n=188, 185, 99, 190) 100 110 37 93
Month 6 (n=174, 181, 94, 182) 100 100 46 93
31.Secondary Outcome
Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 150 151 49 38 160
Measure Type: Number
Unit of Measure: participants
80 84 28 19 75
32.Secondary Outcome
Title Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 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 1, 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 200 199 106 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=200, 199, 106, 201) 0.43  (0.32) 0.43  (0.32) 0.50  (0.28) 0.45  (0.29)
Month 1 (n=192, 195, 106, 198) 0.61  (0.23) 0.60  (0.25) 0.56  (0.25) 0.58  (0.27)
Month 3 (n=187, 184, 99, 189) 0.62  (0.28) 0.64  (0.28) 0.55  (0.27) 0.61  (0.26)
Month 6 (n=172, 180, 46, 178) 0.66  (0.26) 0.65  (0.25) 0.58  (0.28) 0.64  (0.24)
33.Secondary Outcome
Title Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12
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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 147 151 49 38 159
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.69  (0.22) 0.69  (0.22) 0.68  (0.20) 0.66  (0.19) 0.66  (0.27)
34.Secondary Outcome
Title Work Limitations Questionnaire (WLQ) Score at 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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Time Frame Month 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 85 81 42 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: TMS (n=79, 77, 40, 76) 41.46  (23.42) 42.09  (28.98) 37.65  (23.69) 46.43  (25.94)
Baseline: PDS (n=85, 76, 40, 77) 49.99  (23.16) 52.14  (24.22) 53.24  (23.62) 44.51  (21.15)
Baseline: MIDS (n=82, 79, 41, 77) 26.80  (22.80) 27.30  (22.32) 24.85  (28.33) 28.45  (23.77)
Baseline: ODS (n=80, 74, 40, 77) 36.34  (26.55) 37.29  (28.16) 29.28  (26.41) 36.82  (22.71)
Baseline: WLI (n=85, 81, 42, 81) 9.76  (5.34) 9.85  (5.67) 8.83  (5.90) 9.92  (5.01)
Month 3: TMS (n=74, 68, 40, 70) 31.31  (25.50) 21.97  (25.52) 34.26  (26.40) 35.73  (28.50)
Month 3: PDS (n=77, 72, 39, 76) 53.03  (26.21) 47.04  (33.97) 55.57  (27.38) 54.38  (28.15)
Month 3: MIDS (n=78, 72, 41, 73) 21.45  (22.03) 15.14  (20.53) 23.20  (26.04) 22.64  (21.97)
Month 3: ODS (n=75, 70, 39, 76) 26.64  (23.61) 19.31  (23.89) 27.44  (25.18) 26.57  (22.50)
Month 3: WLI (n=80, 74, 41, 78) 7.89  (5.12) 5.92  (5.17) 8.39  (5.73) 8.23  (5.47)
Month 6: PDS (n=66, 65, 15, 71) 55.62  (30.05) 53.57  (36.13) 55.03  (29.84) 52.17  (28.69)
Month 6: TMS (n=68, 65, 16, 67) 29.87  (26.81) 21.30  (27.67) 24.53  (24.19) 29.70  (25.24)
Month 6: MIDS (n=70, 68, 16, 71) 17.50  (21.18) 12.87  (22.77) 18.26  (23.15) 22.61  (22.38)
Month 6: ODS (n=67, 67, 16, 69) 23.18  (25.53) 16.44  (23.79) 19.69  (20.77) 25.82  (22.93)
Month 6: WLI (n= 70, 69, 16, 73) 7.32  (5.47) 5.69  (5.54) 6.89  (4.90) 7.84  (5.04)
35.Secondary Outcome
Title Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 57 55 21 14 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
TMS (n=55, 53, 20, 14, 57) 25.59  (25.10) 20.77  (28.68) 32.69  (29.07) 28.75  (28.26) 26.57  (26.68)
PDS (n=55, 52, 18, 14, 58) 54.35  (32.96) 55.69  (38.22) 51.81  (32.57) 59.02  (36.59) 50.41  (33.98)
MIDS (n=55, 51, 21, 14, 58) 14.72  (19.96) 13.96  (23.76) 21.46  (27.11) 19.44  (24.29) 17.99  (20.10)
ODS (n=57, 50, 19, 14, 58) 20.51  (23.13) 17.35  (27.77) 27.11  (27.29) 25.36  (29.64) 21.55  (22.63)
WLI (n=57, 55, 21, 14, 60) 6.61  (5.07) 5.78  (5.59) 7.75  (6.53) 8.06  (6.01) 6.85  (5.21)
36.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: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Time Frame Baseline, Month 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 201 199 106 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Seen any doctor (n=201, 199, 106, 201) 1.16  (0.37) 1.13  (0.34) 1.15  (0.36) 1.15  (0.36)
Baseline: Treated in ER (n=201, 199, 106, 201) 1.95  (0.23) 1.93  (0.26) 1.93  (0.25) 1.94  (0.25)
Baseline: Admitted overnight stay (n=11,14,6,12) 0.45  (0.82) 0.21  (0.43) 0.17  (0.41) 0.08  (0.29)
Baseline: Hospitalization (n=201, 199, 106, 201) 1.94  (0.24) 1.97  (0.17) 1.93  (0.25) 1.95  (0.23)
Baseline: Outpatient surgeries (n=200,199,106,201) 1.96  (0.20) 1.97  (0.17) 1.98  (0.14) 1.97  (0.18)
Baseline: Diagnostic tests (n=200,199,106,200) 1.81  (0.39) 1.83  (0.37) 1.82  (0.39) 1.82  (0.39)
Baseline: In nursing home (n=201, 199, 106, 201) 1.99  (0.12) 2.00  (0.00) 2.00  (0.00) 1.98  (0.14)
Baseline: Home HC services (n=201, 198, 106, 201) 1.99  (0.10) 1.99  (0.10) 1.99  (0.10) 1.99  (0.12)
Baseline:Required aids/devices (n=201,199,106,201) 1.92  (0.28) 1.86  (0.35) 1.92  (0.28) 1.91  (0.29)
Baseline: Seen NM practitioner (n=201,199,106,201) 1.99  (0.12) 1.97  (0.17) 1.98  (0.14) 1.97  (0.17)
Baseline: Currently employed (n=201,199,106,201) 1.64  (0.48) 1.65  (0.48) 1.64  (0.48) 1.65  (0.48)
Baseline: Feel well enough to work (n=73,83,39,81) 1.90  (0.30) 1.89  (0.31) 1.82  (0.39) 1.80  (0.40)
Baseline: Retired (n=80,88,45,89) 1.41  (0.50) 1.41  (0.49) 1.40  (0.50) 1.39  (0.49)
Baseline: Lost job/retired early(n=66,82,39,81) 1.50  (0.50) 1.70  (0.46) 1.74  (0.44) 1.57  (0.50)
Baseline: Unable to work due to RA (n=76,84,40,78) 1.36  (0.48) 1.37  (0.49) 1.45  (0.50) 1.37  (0.49)
Baseline: Work disabled due to RA (n=66,82,40,79) 1.56  (0.50) 1.70  (0.46) 1.70  (0.46) 1.65  (0.48)
Baseline: Sick leave due to RA (n=167,166,92,167) 1.85  (0.36) 1.86  (0.35) 1.84  (0.37) 1.83  (0.38)
Baseline: Part time work (n=169,166,92,167) 1.92  (0.27) 1.92  (0.27) 1.93  (0.25) 1.94  (0.24)
Baseline: Performed paid work(n=169,166,91,167) 1.69  (0.46) 1.70  (0.46) 1.66  (0.48) 1.67  (0.47)
Baseline: Unable to do chores (n=201,199,105,198) 1.41  (0.49) 1.46  (0.50) 1.53  (0.50) 1.41  (0.49)
Baseline: Chores by housekeeper(n=201,199,106,201) 1.89  (0.32) 1.90  (0.29) 1.93  (0.25) 1.91  (0.29)
Baseline: Chores by family (n=200,199,106,201) 1.50  (0.50) 1.48  (0.50) 1.62  (0.49) 1.51  (0.50)
Month 3: Seen any doctor (n=186,185,99,190) 1.27  (0.45) 1.28  (0.45) 1.22  (0.42) 1.29  (0.45)
Month 3: Treated in ER (n=186,185,99,190) 1.96  (0.20) 1.96  (0.19) 1.96  (0.20) 1.95  (0.22)
Month 3: Admitted overnight stay (n=8,8,4,9) 0.25  (0.46) 0.88  (0.99) 0.00  (0.00) 0.22  (0.44)
Month 3: Hospitalization (n=185,185,99,190) 1.98  (0.15) 1.97  (0.16) 1.99  (0.10) 1.98  (0.12)
Month 3: Outpatient surgeries (n=185,185,99,190) 1.98  (0.13) 1.98  (0.15) 1.96  (0.20) 1.97  (0.18)
Month 3: Diagnostic tests (n=184,185,99,190) 1.90  (0.30) 1.87  (0.34) 1.91  (0.29) 1.89  (0.31)
Month 3: In nursing home (n=185,185,99,190) 1.99  (0.07) 2.00  (0.00) 2.00  (0.00) 1.99  (0.10)
Month 3: Home HC services (n=184,185,99,190) 1.99  (0.07) 2.00  (0.00) 2.00  (0.00) 2.00  (0.00)
Month 3: Required aids/devices (n=185,185,99,190) 1.94  (0.25) 1.91  (0.29) 1.92  (0.27) 1.92  (0.28)
Month 3: Seen NM practitioner (n=185,185,99,190) 1.97  (0.16) 2.00  (0.00) 1.98  (0.14) 1.98  (0.12)
Month 3: Currently employed (n=185,185,99,190) 1.62  (0.49) 1.64  (0.48) 1.63  (0.49) 1.64  (0.48)
Month 3: Feel well enough to work (n=74,79,41,80) 1.70  (0.46) 1.73  (0.44) 1.93  (0.26) 1.74  (0.44)
Month 3: Retired (n=80,86,47,86) 1.39  (0.49) 1.34  (0.48) 1.38  (0.49) 1.38  (0.49)
Month 3: Lost job/retired early(n=73,78,40,79) 1.55  (0.50) 1.59  (0.50) 1.75  (0.44) 1.65  (0.48)
Month 3: Unable to work due to RA (n=76,83,44,77) 1.42  (0.50) 1.46  (0.50) 1.45  (0.50) 1.58  (0.50)
Month 3: Work disabled due to RA (n=71,82,41,73) 1.63  (0.49) 1.68  (0.47) 1.61  (0.49) 1.74  (0.44)
Month 3: Sick leave due to RA (n=153,146,85,157) 1.93  (0.26) 1.94  (0.24) 1.81  (0.39) 1.90  (0.29)
Month 3: Part time work (n=153,145,85,155) 1.95  (0.21) 1.97  (0.16) 1.94  (0.24) 1.94  (0.25)
Month 3: Performed paid work(n=153,145,85,157) 1.73  (0.45) 1.81  (0.39) 1.68  (0.47) 1.70  (0.46)
Month 3: Unable to do chores(n=182,182,99,189) 1.62  (0.49) 1.71  (0.46) 1.59  (0.50) 1.66  (0.47)
Month 3: Chores by housekeeper (n=184,183,99,190) 1.91  (0.29) 1.94  (0.24) 1.93  (0.26) 1.94  (0.24)
Month 3: Chores by family (n=183,183,99,190) 1.67  (0.47) 1.74  (0.44) 1.66  (0.48) 1.68  (0.47)
Month 6: Seen any doctor (n=173,180,45,179) 1.25  (0.43) 1.28  (0.45) 1.27  (0.45) 1.31  (0.46)
Month 6: Treated in ER (n=173,180,46,179) 1.93  (0.25) 1.97  (0.18) 1.91  (0.28) 1.98  (0.15)
Month 6: Admitted overnight stay (n=12,6,4,3) 0.58  (0.67) 0.17  (0.41) 0.00  (0.00) 0.00  (0.00)
Month 6: Hospitalization (n=172,180,46,179) 1.95  (0.22) 1.97  (0.16) 1.96  (0.21) 1.99  (0.07)
Month 6: Outpatient surgeries (n=173,180,46,178) 1.98  (0.15) 1.96  (0.19) 1.98  (0.15) 1.99  (0.11)
Month 6: Diagnostic tests (n=173,180,46,178) 1.87  (0.33) 1.86  (0.35) 1.89  (0.31) 1.89  (0.31)
Month 6: In nursing home (n=173,180,46,178) 1.99  (0.11) 2.00  (0.00) 2.00  (0.00) 2.00  (0.00)
Month 6: Home HC services (n=173,180,46,177) 1.99  (0.11) 1.99  (0.11) 2.00  (0.00) 2.00  (0.00)
Month 6: Required aids/devices (n=173,180,46,178) 1.91  (0.28) 1.91  (0.29) 1.87  (0.34) 1.92  (0.27)
Month 6: Seen NM practitioner (n=173,180,45,178) 2.00  (0.00) 1.98  (0.13) 2.00  (0.00) 1.99  (0.07)
Month 6: Currently employed (n=173,180,46,179) 1.62  (0.49) 1.66  (0.48) 1.63  (0.49) 1.63  (0.48)
Month 6: Feel well enough to work (72,81,23,76) 1.75  (0.44) 1.77  (0.43) 1.83  (0.39) 1.71  (0.46)
Month 6: Retired (n=77,87,22,82) 1.32  (0.47) 1.30  (0.46) 1.32  (0.48) 1.35  (0.48)
Month 6: Lost job/retired early (n=70,82,22,72) 1.57  (0.50) 1.66  (0.48) 1.68  (0.48) 1.67  (0.47)
Month 6: Unable to work due to RA (n=73,83,23,74) 1.51  (0.50) 1.54  (0.50) 1.48  (0.51) 1.57  (0.50)
Month 6: Work disabled due to RA (n=67,80,22,72) 1.72  (0.45) 1.70  (0.46) 1.73  (0.46) 1.72  (0.45)
Month 6: Sick leave due to RA (n=138,134,38,144) 1.93  (0.25) 1.93  (0.25) 1.92  (0.27) 1.94  (0.24)
Month 6: Part time work (n=135,134,37,142) 1.94  (0.24) 1.96  (0.21) 1.97  (0.16) 1.95  (0.22)
Month 6: Performed paid work (n=136,136,38,142) 1.75  (0.43) 1.80  (0.40) 1.74  (0.45) 1.76  (0.43)
Month 6: Unable to do chores(n=171,178,45,175) 1.70  (0.46) 1.74  (0.44) 1.62  (0.49) 1.67  (0.47)
Month 6: Chores by housekeeper (n=172,180,45,180) 1.92  (0.27) 1.94  (0.23) 1.93  (0.25) 1.96  (0.19)
Month 6: Chores by family (n=172,180,46,180) 1.72  (0.45) 1.74  (0.44) 1.67  (0.47) 1.71  (0.45)
37.Secondary Outcome
Title Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Hide Description RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 148 151 49 38 160
Mean (Standard Deviation)
Unit of Measure: units on a scale
Seen any doctor (n=148,151,49,38,160) 1.31  (0.46) 1.27  (0.45) 1.24  (0.43) 1.24  (0.43) 1.23  (0.42)
Treated in ER (n=149,151,49,38,160) 1.98  (0.14) 1.97  (0.18) 2.00  (0.00) 1.97  (0.16) 1.96  (0.19)
Admitted overnight stay (n=3,5,0,1,6) 0.33  (0.58) 0.20  (0.45) NA [1]   (NA) 0.00 [2]   (NA) 0.17  (0.41)
Hospitalization (n=148,151,49,38,160) 1.98  (0.14) 1.97  (0.18) 1.98  (0.14) 1.97  (0.16) 1.98  (0.14)
Outpatient surgeries (n=148,151,49,38,160) 1.97  (0.18) 1.99  (0.11) 2.00  (0.00) 1.95  (0.23) 1.97  (0.17)
Diagnostic tests (n=149,151,49,38,159) 1.94  (0.24) 1.87  (0.33) 1.88  (0.33) 1.84  (0.37) 1.86  (0.35)
In nursing home (n=149,151,49,38,159) 1.99  (0.12) 2.00  (0.00) 2.00  (0.00) 2.00  (0.00) 1.99  (0.08)
Home HC services (n=148,151,49,38,159) 2.00  (0.00) 2.00  (0.00) 2.00  (0.00) 2.00  (0.00) 1.99  (0.08)
Required aids/devices (n=148,151,49,38,160) 1.93  (0.26) 1.92  (0.27) 1.94  (0.24) 1.92  (0.27) 1.91  (0.29)
Seen NM practitioner(n=149,151,49,38,160) 1.98  (0.14) 1.97  (0.16) 1.98  (0.14) 1.95  (0.23) 2.00  (0.00)
Currently employed (n=148,151,49,38,160) 1.59  (0.49) 1.68  (0.47) 1.61  (0.49) 1.61  (0.50) 1.64  (0.48)
Feel well enough to work (n=61,79,19,19,76) 1.72  (0.45) 1.75  (0.44) 1.84  (0.37) 1.84  (0.37) 1.68  (0.47)
Retired (n=64,84,21,19,80) 1.25  (0.44) 1.31  (0.47) 1.19  (0.40) 1.53  (0.51) 1.35  (0.48)
Lost job/retired early (n=58,75,19,18,75) 1.53  (0.50) 1.72  (0.45) 1.68  (0.48) 1.78  (0.43) 1.67  (0.47)
Unable to work due to RA (n=59,77,19,19,77) 1.56  (0.50) 1.61  (0.49) 1.58  (0.51) 1.58  (0.51) 1.57  (0.50)
Work disabled due to RA (n=58,76,19,18,75) 1.64  (0.48) 1.75  (0.44) 1.79  (0.42) 1.67  (0.49) 1.67  (0.47)
Sick leave due to RA (n=118,112,37,30,124) 1.96  (0.20) 1.96  (0.19) 1.95  (0.23) 2.00  (0.00) 1.97  (0.18)
Part time work (n=117,112,37,30,123) 1.95  (0.22) 1.99  (0.09) 2.00  (0.00) 2.00  (0.00) 1.99  (0.09)
Performed paid work (n=118,114,37,31,123) 1.83  (0.38) 1.82  (0.39) 1.78  (0.42) 1.71  (0.46) 1.82  (0.38)
Unable to do chores (n=146,150,47,38,154) 1.81  (0.40) 1.75  (0.44) 1.79  (0.41) 1.84  (0.37) 1.73  (0.45)
Chores by housekeeper (n=148,151,49,38,160) 1.94  (0.24) 1.97  (0.16) 1.96  (0.20) 1.95  (0.23) 1.93  (0.25)
Chores by family (n=145,151,49,38,160) 1.76  (0.43) 1.80  (0.40) 1.84  (0.37) 1.71  (0.46) 1.71  (0.45)
[1]
Data not available as no participant was evaluable for the treatment arm at the given time point.
[2]
Standard deviation was not estimable since only 1 participant was evaluable.
38.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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 168 174 90 172
Mean (Standard Deviation)
Unit of Measure: events
Baseline: Doctor visits (n=168,174,90,172) 4.26  (3.51) 4.06  (3.57) 4.50  (5.32) 3.87  (3.74)
Baseline: NM practitioners visits (n=3,6,2,6) 1.33  (0.58) 3.00  (1.79) 4.50  (4.95) 10.00  (10.51)
Baseline: Hospital ER visits (n=12,14,7,12) 1.08  (0.51) 1.93  (1.59) 1.57  (0.79) 1.58  (1.73)
Baseline: Number visits hospitalized(n=11,5,7,11) 2.82  (5.71) 1.00  (0.00) 1.00  (0.00) 1.27  (0.90)
Baseline:Number of outpatient surgeries(n=8,6,2,7) 1.13  (0.35) 1.33  (0.82) 1.00  (0.00) 2.57  (4.16)
Baseline:Non-study diagnostic tests(n=37,33,19,36) 1.73  (1.04) 1.79  (1.17) 1.21  (0.54) 1.64  (1.10)
Baseline:RA related doctor visit(n=169,175,91,172) 1.33  (1.03) 1.17  (0.70) 1.26  (0.81) 1.19  (0.73)
Baseline: RA related ER visit (n=11,14,6,12) 0.64  (0.81) 0.64  (0.74) 0.17  (0.41) 0.25  (0.45)
Baseline: RA diagnostic tests (n=38,33,19,37) 0.50  (0.76) 0.55  (0.62) 0.47  (0.61) 0.84  (0.73)
Baseline: RA related hospitalization (n=11,6,7,11) 0.91  (0.83) 0.67  (0.52) 0.57  (0.79) 0.82  (0.60)
Baseline: RA related outpatient surgery(n=7,6,3,7) 0.43  (0.79) 0.33  (0.82) 0.33  (0.58) 0.43  (0.79)
Baseline: RA related NM visit (n=3,6,2,6) 0.67  (0.58) 0.50  (0.84) 1.00  (0.00) 1.00  (0.63)
Month 3: Doctor visits (n=136,138,78,136) 3.62  (4.25) 2.86  (2.99) 3.27  (3.93) 3.05  (2.87)
Month 3: NM practitioners visits (n=5,0,2,2) 2.40  (0.89) NA [1]   (NA) 17.00  (21.21) 7.50  (9.19)
Month 3: Hospital ER visits (n=8,8,4,10) 1.38  (0.74) 1.00  (0.00) 1.75  (1.50) 1.90  (1.10)
Month 3: Number visits hospitalized (n=4,6,1,3) 1.50  (1.00) 1.00  (0.00) 1.00 [2]   (NA) 1.00  (0.00)
Month 3: Number of outpatient surgeries(n=3,4,4,6) 1.67  (0.58) 1.00  (0.00) 1.00  (0.00) 1.33  (0.52)
Month 3: Non-study diagnostic tests (n=18,23,9,20) 1.72  (1.41) 1.52  (0.79) 1.56  (0.88) 1.45  (0.83)
Month 3: RA related doctor visit(n=136,138,78,136) 0.91  (0.75) 0.92  (0.67) 0.90  (0.71) 0.93  (0.65)
Month 3: RA related ER visit (n=8,8,4,9) 0.25  (0.46) 0.50  (0.76) 0.00  (0.00) 0.00  (0.00)
Month 3: RA-diagnostic tests (n=19,24,9,21) 0.11  (0.32) 0.21  (0.51) 0.11  (0.33) 0.24  (0.44)
Month 3: RA related hospitalization (n=4,6,1,3) 0.00  (0.00) 0.17  (0.41) 0.00 [3]   (NA) 0.67  (1.15)
Month 3: RA related outpatient surgery (n=3,4,4,6) 0.00  (0.00) 0.25  (0.50) 0.25  (0.50) 0.00  (0.00)
Month 3: RA related NM visit (n=5,0,2,2) 0.60  (0.89) NA [1]   (NA) 1.50  (0.71) 0.50  (0.71)
Month 6: Doctor visits (n=132,131,33,128) 3.30  (4.17) 2.86  (4.23) 2.52  (1.91) 2.73  (2.96)
Month 6: NM practitioners visits (n=1,3,0,1) 1.00 [2]   (NA) 2.67  (2.89) NA [1]   (NA) 14.00 [2]   (NA)
Month 6: Hospital ER visits (n=12,6,4,4) 1.08  (0.29) 1.17  (0.41) 1.00  (0.00) 1.75  (0.96)
Month 6: Number visits hospitalized (n=9,5,2,1) 1.00  (0.00) 1.00  (0.00) 1.00  (0.00) 1.00 [2]   (NA)
Month 6: Number of outpatient surgeries(n=4,7,1,2) 1.25  (0.50) 1.14  (0.38) 1.00 [2]   (NA) 1.50  (0.71)
Month 6: Non-study diagnostic tests (n=21,25,5,19) 2.33  (3.89) 1.96  (1.31) 1.80  (0.45) 1.53  (0.61)
Month 6: RA related doctor visit(n=132,131,33,129) 0.81  (0.63) 0.96  (0.74) 0.88  (0.86) 1.00  (0.56)
Month 6: RA related ER visit (n=12,6,4,3) 0.25  (0.62) 0.67  (0.82) 0.00  (0.00) 0.00  (0.00)
Month 6: RA-diagnostic tests (n=21,25,5,19) 0.18  (0.50) 0.16  (0.37) 0.20  (0.45) 0.11  (0.32)
Month 6: RA related hospitalization (n=9,5,2,1) 0.22  (0.67) 0.40  (0.89) 0.00  (0.00) 0.00 [3]   (NA)
Month 6: RA related outpatient surgery (n=4,7,1,2) 0.00  (0.00) 0.43  (0.79) 0.00 [3]   (NA) 1.00  (1.41)
Month 6: RA related NM visit (n=1,3,0,1) 0.00 [3]   (NA) 0.67  (1.15) NA [1]   (NA) 0.00 [4]   (NA)
[1]
Data not available as no participant was evaluable for the treatment arm at the given time point.
[2]
Standard deviation was not estimable since only 1 participant was evaluable.
[3]
Standard deviation was not estimable since only 1 participant were evaluable.
[4]
Standard deviation was not estimable as only 1 participant was evaluable.
39.Secondary Outcome
Title Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 104 111 37 30 125
Mean (Standard Deviation)
Unit of Measure: events
Doctor visit (n=102,111,37,30,125) 2.73  (2.78) 2.80  (2.46) 3.92  (5.97) 3.50  (3.34) 2.94  (3.93)
NM practitioners visits (n=3,4,1,2,0) 10.67  (11.72) 9.75  (10.97) 192.00 [1]   (NA) 10.50  (6.36) NA [2]   (NA)
Hospital ER visits (n=3,5,0,1,6) 1.00  (0.00) 2.40  (1.34) NA [2]   (NA) 3.00 [1]   (NA) 1.00  (0.00)
Number of visits hospitalized (n=3,5,1,1,3) 1.00  (0.00) 1.00  (0.00) 1.00 [1]   (NA) 1.00 [1]   (NA) 1.00  (0.00)
Number of outpatient surgeries (n=5,2,0,2,5) 1.40  (0.89) 1.50  (0.71) NA [2]   (NA) 1.00  (0.00) 2.20  (2.17)
Non-study diagnostic tests (n=8,19,6,6,22) 1.13  (0.35) 1.95  (1.31) 3.17  (2.64) 1.33  (0.82) 1.64  (0.90)
RA related doctor visit (n=104,111,37,30,125) 0.82  (0.59) 0.93  (0.57) 0.89  (0.52) 0.87  (0.68) 0.84  (0.80)
RA related ER visits (n=3,5,0,1,6) 0.33  (0.58) 0.00  (0.00) NA [2]   (NA) 0.00 [1]   (NA) 0.17  (0.41)
RA-diagnostic tests (n=9,19,6,6,22) 0.11  (0.33) 0.21  (0.42) 0.17  (0.41) 0.00  (0.00) 0.05  (0.21)
RA related hospitalization (n=3,5,1,1,3) 0.00  (0.00) 0.00  (0.00) 0.00 [3]   (NA) 0.00 [3]   (NA) 0.67  (0.58)
RA related outpatient surgery (n=5,2,0,2,5) 0.00  (0.00) 0.00  (0.00) NA [2]   (NA) 0.00  (0.00) 0.00  (0.00)
RA related NM visits (n=3,4,1,2,0) 0.00  (0.00) 0.50  (1.00) 0.00 [4]   (NA) 0.00  (0.00) NA [2]   (NA)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
Data not available as no participant was evaluable for the treatment arm at the given time point.
[3]
Standard deviation was not estimable since only 1 participant were evaluable.
[4]
Standard deviation was not estimable as only 1 participant was evaluable.
40.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 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 101 102 39 97
Mean (Standard Deviation)
Unit of Measure: days
Baseline: Hospital length of stay (n=11,6,7,11) 13.64  (12.91) 10.83  (9.89) 13.43  (9.78) 12.82  (10.93)
Baseline: Days in nursing home (n=3,0,0,4) 19.33  (17.56) NA [1]   (NA) NA [1]   (NA) 14.25  (9.95)
Baseline: Days devices/aids used (n=17,28,8,16) 133.88  (111.17) 67.32  (61.88) 172.75  (94.28) 66.13  (65.33)
Baseline: Days of work per week (n=71,69,38,70) 4.94  (1.18) 4.80  (1.05) 4.95  (0.98) 5.01  (1.04)
Baseline: Chores by housekeeper (n=23,19,6,18) 15.57  (25.73) 14.95  (27.24) 38.83  (41.44) 6.94  (6.86)
Baseline: Chores by family (n=101,102,39,97) 24.06  (29.27) 26.57  (31.02) 26.95  (32.87) 29.80  (32.91)
Baseline: Days on sick leave (n=24,24,15,29) 19.58  (27.78) 16.33  (27.21) 29.60  (34.88) 16.31  (26.05)
Baseline: Days of part time work (n=13,13,6,10) 13.31  (18.94) 25.31  (61.19) 5.33  (3.44) 18.50  (26.88)
Baseline: Paid work, bothered by RA(n=51,47,31,53) 29.10  (27.47) 29.45  (31.37) 28.74  (28.76) 42.74  (31.81)
Baseline: RA related devices/aids (n=17,28,9,17) 1.76  (1.15) 1.39  (0.69) 2.33  (1.66) 1.65  (1.06)
Month 3: Hospital length of stay (n=4,6,1,3) 6.25  (4.03) 10.00  (10.75) 2.00 [2]   (NA) 10.33  (8.14)
Month 3: Days in nursing home (n=0,0,0,2) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 17.50  (4.95)
Month 3: Days devices/aids used (n=11,17,6,15) 117.91  (112.91) 60.41  (88.79) 163.83  (153.63) 91.80  (95.18)
Month 3: Days of work per week (n=70,66,38,68) 4.83  (0.95) 4.68  (1.18) 4.95  (0.80) 4.75  (1.25)
Month 3: Chores by housekeeper (n=17,11,7,12) 12.59  (23.15) 6.00  (8.63) 8.00  (12.54) 10.50  (16.08)
Month 3: Chores by family (n=60,47,34,58) 24.10  (32.38) 18.32  (24.03) 24.97  (31.72) 25.41  (30.46)
Month 3: Days on sick leave (n=11,9,17,15) 24.27  (33.73) 18.44  (29.37) 27.12  (31.42) 5.13  (4.60)
Month 3: Days of part time work (n=7,4,6,10) 13.29  (13.76) 25.50  (27.77) 5.50  (3.27) 14.90  (27.04)
Month 3: Paid work, bothered by RA (n=39,28,28,44) 16.08  (21.77) 26.57  (32.41) 19.93  (20.79) 33.61  (30.31)
Month 3: RA related devices/aids (n=12,17,8,16) 1.75  (1.22) 1.12  (1.36) 2.38  (1.60) 1.81  (0.98)
Month 6: Hospital length of stay (n=9,5,2,1) 10.00  (8.20) 12.80  (16.71) 8.50  (2.12) 6.00 [2]   (NA)
Month 6: Days in nursing home (n=2,0,0,0) 27.00  (18.38) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
Month 6: Days devices/aids used (n=14,16,5,14) 102.29  (115.01) 126.25  (134.08) 80.20  (73.45) 94.21  (76.92)
Month 6: Days of work per week (n=65,61,17,66) 4.94  (0.85) 4.70  (1.09) 5.35  (0.93) 4.95  (0.92)
Month 6: Chores by housekeeper (n=11,10,3,7) 7.73  (8.25) 15.80  (22.73) 44.00  (42.57) 7.29  (3.82)
Month 6: Chores by family (n=46,46,15,50) 13.59  (16.95) 29.09  (35.16) 35.53  (39.39) 22.64  (29.51)
Month 6: Days on sick leave (n=7,9,3,9) 29.57  (41.48) 12.44  (14.60) 3.00  (2.00) 8.67  (13.13)
Month 6: Days of part time work (n=7,6,1,7) 7.57  (6.80) 24.67  (33.07) 4.00 [2]   (NA) 9.29  (8.67)
Month 6: Paid work, bothered by RA (n=31,25,10,33) 14.71  (18.47) 20.40  (25.93) 11.00  (9.13) 24.55  (26.88)
Month 6: RA related devices/aids (n=15,16,6,14) 2.00  (1.73) 1.56  (1.46) 2.17  (1.83) 2.07  (1.27)
[1]
Data not available as no participant was evaluable for the treatment arm at the given time point.
[2]
Standard deviation was not estimable since only 1 participant was evaluable.
41.Secondary Outcome
Title Number of Days as Assessed Using RA-HCRU at Month 12
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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 60 49 19 15 58
Mean (Standard Deviation)
Unit of Measure: days
Hospital length of stay (n=3,5,1,1,3) 8.00  (6.93) 5.60  (2.70) 15.00 [1]   (NA) 1.00 [1]   (NA) 15.33  (4.51)
Days in nursing home (n=2,0,0,0,1) 24.50  (4.95) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) 10.00 [1]   (NA)
Days devices/aids used (n=11,12,3,2,15) 144.55  (258.85) 51.75  (41.51) 163.67  (173.70) 321.50  (327.39) 79.33  (74.00)
Days of work per week (n=60,49,19,15,58) 4.83  (1.04) 5.04  (0.93) 5.16  (0.90) 4.93  (0.70) 4.95  (1.07)
Chores by housekeeper (n=9,4,1,2,10) 4.44  (3.40) 7.75  (5.06) 90.00 [1]   (NA) 24.00  (16.97) 4.90  (3.78)
Chores by family (n=35,30,8,10,45) 22.06  (27.84) 13.13  (12.28) 51.88  (40.91) 28.40  (33.88) 23.49  (28.68)
Days on sick leave (n=5,3,2,0,4) 10.40  (11.41) 36.00  (45.97) 50.00  (56.57) NA [2]   (NA) 18.25  (14.06)
Days of part time work (n=6,1,0,0,1) 11.33  (12.55) 33.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA) 30.00 [1]   (NA)
Paid work, bothered by RA (n=20,20,7,9,22) 24.10  (30.75) 20.40  (27.90) 11.43  (8.60) 12.33  (12.32) 22.86  (24.20)
RA related devices/aids used (n=11,12,3,3,15) 2.18  (2.79) 0.75  (0.62) 2.33  (1.53) 3.00  (2.65) 1.53  (0.74)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
Data not available as no participant was evaluable for the treatment arm at the given time point.
42.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, hours affected per day and average number of hours missed work per day were reported.
Time Frame Baseline, Month 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 101 102 39 95
Mean (Standard Deviation)
Unit of Measure: hours per day
Baseline: Home HC services (n=2,2,1,2) 3.00  (2.83) 1.50  (0.71) 2.00 [1]   (NA) 1.00  (0.00)
Baseline: Work done (n=72,69,38,70) 7.76  (2.40) 7.54  (2.25) 7.79  (1.76) 8.16  (2.85)
Baseline: Chores by housekeeper (n=22,19,7,18) 5.23  (4.60) 5.53  (5.36) 8.00  (7.55) 3.89  (2.37)
Baseline: Chores by family (n=101,102,39,95) 4.24  (4.75) 3.31  (2.76) 4.21  (4.71) 2.82  (1.79)
Baseline: Missed work due to RA (n=13,13,6,10) 6.38  (7.22) 5.00  (5.85) 4.00  (1.26) 4.00  (4.11)
Baseline: RA related home HC services (n=2,2,1,3) 0.50  (0.71) 1.00  (0.00) 1.00 [1]   (NA) 0.33  (0.58)
Month 3: Home HC services (n=1,0,0,0) 1.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Month 3: Work done (n=70,66,38,68) 8.06  (3.59) 7.53  (1.92) 8.53  (5.62) 8.38  (4.89)
Month 3: Chores by housekeeper (n=17,11,7,12) 4.00  (2.12) 5.73  (2.61) 5.00  (2.00) 4.17  (1.99)
Month 3: Chores by family (n=59,46,34,59) 3.46  (3.67) 3.28  (2.60) 3.41  (2.72) 3.68  (3.72)
Month 3: Missed work due to RA (n=7,4,6,9) 4.57  (5.03) 20.75  (39.51) 5.50  (5.01) 3.56  (1.59)
Month 3: RA related home HC services (n=1,0,0,0) 1.00 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Month 6: Home HC services (n=2,2,0,0) 2.50  (2.12) 16.00  (5.66) NA [2]   (NA) NA [2]   (NA)
Month 6: Work done (n=65,61,17,66) 8.35  (4.46) 7.72  (2.24) 9.71  (7.59) 8.00  (4.27)
Month 6: Chores by housekeeper (n=11,10,3,7) 3.36  (2.58) 5.40  (2.50) 5.33  (1.53) 6.29  (7.95)
Month 6: Chores by family (n=47,45,13,51) 3.30  (2.69) 2.91  (2.00) 3.69  (2.32) 3.33  (3.55)
Month 6: Missed work due to RA (n=7,6,1,7) 4.57  (5.19) 3.17  (2.32) 5.00 [1]   (NA) 3.29  (1.70)
Month 6: RA related home HC services (n=2,2,0,0) 1.00  (1.41) 0.50  (0.71) NA [2]   (NA) NA [2]   (NA)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
Data not available as no participant was evaluable for the treatment arm at the given time point.
43.Secondary Outcome
Title Number of Hours Per Day as Assessed RA-HCRU at Month 12
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, hours affected per day and average number of hours missed work per day were reported.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 60 49 19 15 58
Mean (Standard Deviation)
Unit of Measure: hours per day
Home HC services (n=0,0,0,0,1) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 1.00 [2]   (NA)
Work done (n=60,49,19,15,58) 7.52  (2.27) 7.82  (1.60) 9.53  (7.65) 7.73  (2.40) 7.93  (3.12)
Chores by housekeeper (n=8,4,1,2,10) 4.63  (3.16) 4.75  (0.96) 3.00 [2]   (NA) 6.00  (1.41) 4.10  (2.08)
Chores by family (n=34,30,8,10,44) 2.65  (1.95) 4.00  (4.11) 2.88  (2.17) 2.70  (2.26) 2.55  (1.81)
Missed work due to RA (n=6,1,0,0,1) 2.00  (1.67) 4.00 [2]   (NA) NA [1]   (NA) NA [1]   (NA) 4.00 [2]   (NA)
RA related home HC services (n=0,0,0,0,1) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 1.00 [2]   (NA)
[1]
Data not available as no participant was evaluable for the treatment arm at the given time point.
[2]
Standard deviation was not estimable since only 1 participant was evaluable.
44.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 10-point scale, where higher score indicated lower work performance.
Time Frame Baseline, Month 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 5 mg CP-690,550 10 mg Placebo Adalimumab
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Overall Number of Participants Analyzed 139 141 83 142
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=139,141,83,142) 4.16  (3.05) 4.16  (3.33) 4.08  (3.32) 4.19  (3.09)
Month 3 (n=137,129,76,139) 2.68  (2.75) 2.81  (2.89) 3.38  (2.84) 3.09  (2.81)
Month 6 (n=125,125,35,127) 2.31  (2.51) 2.39  (2.84) 2.17  (2.64) 2.66  (2.54)
45.Secondary Outcome
Title Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Hide Description Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
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 Adalimumab