We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00550446
Recruitment Status : Completed
First Posted : October 29, 2007
Results First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: Adalimumab
Drug: CP-690-550
Drug: CP-690,550
Drug: Placebo
Enrollment 386
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Placebo CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg to CP-690,550 5 mg (R) Adalimumab to CP-690,550 5 mg (R) Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24. Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Period Title: Up To Week 12
Started 54 52 50 61 57 53 59 0 0 0 0
Treated 54 51 49 61 57 53 59 0 0 0 0
Completed 44 47 46 58 54 45 46 0 0 0 0
Not Completed 10 5 4 3 3 8 13 0 0 0 0
Reason Not Completed
Adverse Event             2             2             0             0             2             2             1             0             0             0             0
Lack of Efficacy             3             1             0             1             0             3             3             0             0             0             0
Lost to Follow-up             0             1             0             0             1             1             2             0             0             0             0
Withdrawal by Subject             2             0             3             2             0             1             3             0             0             0             0
Other             3             0             0             0             0             1             4             0             0             0             0
Randomized not treated             0             1             1             0             0             0             0             0             0             0             0
Period Title: Post Week 12
Started 27 30 46 58 54 1 21 17 17 44 25
Completed 24 28 43 55 52 0 19 16 15 37 24
Not Completed 3 2 3 3 2 1 2 1 2 7 1
Reason Not Completed
Adverse Event             2             1             1             1             1             1             0             0             0             4             0
Lack of Efficacy             0             0             1             0             0             0             0             1             1             2             1
Lost to Follow-up             0             0             1             1             0             0             1             0             0             0             0
Withdrawal by Subject             0             0             0             0             1             0             0             0             0             0             0
Other             1             1             0             1             0             0             1             0             1             1             0
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Placebo Total
Hide Arm/Group Description CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24. Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 54 51 49 61 57 53 59 384
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 51 participants 49 participants 61 participants 57 participants 53 participants 59 participants 384 participants
55.1  (13.3) 53.4  (12.2) 53.7  (13.5) 52.4  (10.9) 53.2  (13.0) 53.5  (11.9) 52.5  (13.7) 53.3  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 51 participants 49 participants 61 participants 57 participants 53 participants 59 participants 384 participants
Female
46
  85.2%
44
  86.3%
43
  87.8%
53
  86.9%
50
  87.7%
45
  84.9%
52
  88.1%
333
  86.7%
Male
8
  14.8%
7
  13.7%
6
  12.2%
8
  13.1%
7
  12.3%
8
  15.1%
7
  11.9%
51
  13.3%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
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).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. The analysis used Baseline Observation Carried Forward (BOCF) imputation for missing values.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Placebo
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Overall Number of Participants Analyzed 54 51 49 61 57 53 59
Measure Type: Number
Unit of Measure: percentage of participants
31.48 45.10 61.22 72.13 71.93 39.62 23.73
2.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
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 Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 44 59 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=54,0,51,0,49,61,57,53,0,59,0) 16.67 NA [1]  31.37 NA [1]  32.65 50.82 38.60 26.42 NA [1]  15.25 NA [1] 
Week 4 (n=54,0,51,0,49,61,57,53,0,59,0) 22.22 NA [1]  37.25 NA [1]  40.82 52.46 63.16 28.30 NA [1]  27.12 NA [1] 
Week 6 (n=54,0,51,0,49,61,57,53,0,59,0) 38.89 NA [1]  47.06 NA [1]  63.27 63.93 66.67 30.19 NA [1]  25.42 NA [1] 
Week 8 (n=54,0,51,0,49,61,57,53,0,59,0) 37.04 NA [1]  47.06 NA [1]  63.27 65.57 71.93 35.85 NA [1]  27.12 NA [1] 
Week 10 (n=54,0,51,0,49,61,57,53,0,59,0) 35.19 NA [1]  37.25 NA [1]  57.14 75.41 75.44 35.85 NA [1]  23.73 NA [1] 
Week 16 (n=37,17,34,17,49,61,57,9,44,34,25) 51.4 0.0 58.8 0.0 67.3 70.5 71.9 0.0 0.0 35.3 0.0
Week 20 (n=37,17,34,17,49,61,57,9,44,34,25) 45.9 0.0 64.7 0.0 69.4 73.8 71.9 0.0 0.0 32.4 0.0
Week 24 (n=37,17,34,17,49,61,57,9,44,34,25) 35.1 0.0 58.8 0.0 57.1 73.8 68.4 0.0 0.0 47.1 0.0
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response
Hide Description ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 44 59 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=54,0,51,0,49,61,57,53,0,59,0) 1.85 NA [1]  7.84 NA [1]  8.16 18.03 17.54 7.55 NA [1]  1.69 NA [1] 
Week 4 (n=54,0,51,0,49,61,57,53,0,59,0) 9.26 NA [1]  13.73 NA [1]  10.20 31.15 40.35 9.43 NA [1]  5.08 NA [1] 
Week 6 (n=54,0,51,0,49,61,57,53,0,59,0) 14.81 NA [1]  15.69 NA [1]  14.29 36.07 42.11 16.98 NA [1]  6.78 NA [1] 
Week 8 (n=54,0,51,0,49,61,57,53,0,59,0) 12.96 NA [1]  21.57 NA [1]  24.49 29.51 49.12 16.98 NA [1]  8.47 NA [1] 
Week 10 (n=54,0,51,0,49,61,57,53,0,59,0) 12.96 NA [1]  17.65 NA [1]  34.69 50.82 43.86 15.09 NA [1]  6.78 NA [1] 
Week 12 (n=54,0,51,0,49,61,57,53,0,59,0) 11.11 NA [1]  25.49 NA [1]  38.78 45.90 50.88 20.75 NA [1]  10.17 NA [1] 
Week 16 (n=37,17,34,17,49,61,57,9,44,34,25) 18.9 0.0 38.2 0.0 34.7 42.6 56.1 0.0 0.0 20.6 0.0
Week 20 (n=37,17,34,17,49,61,57,9,44,34,25) 18.9 0.0 44.1 0.0 32.7 42.6 59.6 0.0 0.0 17.6 0.0
Week 24 (n=37,17,34,17,49,61,57,9,44,34,25) 10.8 0.0 44.1 0.0 36.7 45.9 54.4 0.0 0.0 17.6 0.0
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 15 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 44 59 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=54,0,51,0,49,61,57,53,0,59,0) 1.85 NA [1]  1.96 NA [1]  2.04 3.28 7.02 1.89 NA [1]  0.00 NA [1] 
Week 4 (n=54,0,51,0,49,61,57,53,0,59,0) 0.00 NA [1]  5.88 NA [1]  2.04 11.48 8.77 5.66 NA [1]  1.69 NA [1] 
Week 6 (n=54,0,51,0,49,61,57,53,0,59,0) 3.70 NA [1]  1.96 NA [1]  4.08 19.67 17.54 5.66 NA [1]  1.69 NA [1] 
Week 8 (n=54,0,51,0,49,61,57,53,0,59,0) 9.26 NA [1]  3.92 NA [1]  8.16 18.03 24.56 5.66 NA [1]  1.69 NA [1] 
Week 10 (n=54,0,51,0,49,61,57,53,0,59,0) 3.70 NA [1]  7.84 NA [1]  16.33 26.23 21.05 3.77 NA [1]  1.69 NA [1] 
Week 12 (n=54,0,51,0,49,61,57,53,0,59,0) 5.56 NA [1]  11.76 NA [1]  14.29 24.59 26.32 3.77 NA [1]  3.39 NA [1] 
Week 16 (n=37,17,34,17,49,61,57,9,44,34,25) 10.8 0.0 26.5 0.0 20.4 29.5 33.3 0.0 0.0 0.0 0.0
Week 20 (n=37,17,34,17,49,61,57,9,44,34,25) 10.8 0.0 17.6 0.0 18.4 31.1 31.6 0.0 0.0 8.8 0.0
Week 24 (n=37,17,34,17,49,61,57,9,44,34,25) 8.1 0.0 23.5 0.0 22.4 37.7 33.3 0.0 0.0 11.8 0.0
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
5.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Hide Description ACR90 response: >= 90% improvement in TJC or SJC and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 44 59 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=54,0,51,0,49,61,57,53,0,59,0) 1.85 NA [1]  0.00 NA [1]  0.00 1.64 0.00 0.00 NA [1]  0.00 NA [1] 
Week 4 (n=54,0,51,0,49,61,57,53,0,59,0) 0.00 NA [1]  0.00 NA [1]  2.04 3.28 1.75 0.00 NA [1]  0.00 NA [1] 
Week 6 (n=54,0,51,0,49,61,57,53,0,59,0) 0.00 NA [1]  0.00 NA [1]  2.04 6.56 1.75 0.00 NA [1]  0.00 NA [1] 
Week 8 (n=54,0,51,0,49,61,57,53,0,59,0) 1.85 NA [1]  0.00 NA [1]  2.04 9.84 1.75 0.00 NA [1]  0.00 NA [1] 
Week 10 (n=54,0,51,0,49,61,57,53,0,59,0) 1.85 NA [1]  1.96 NA [1]  4.08 9.84 10.53 1.89 NA [1]  0.00 NA [1] 
Week 12 (n=54,0,51,0,49,61,57,53,0,59,0) 1.85 NA [1]  1.96 NA [1]  4.08 11.48 7.02 0.00 NA [1]  0.00 NA [1] 
Week 16 (n=37,17,34,17,49,61,57,9,44,34,25) 2.7 0.0 5.9 0.0 8.2 13.1 8.8 0.0 0.0 0.0 0.0
Week 20 (n=37,17,34,17,49,61,57,9,44,34,25) 2.7 0.0 2.9 0.0 6.1 11.5 10.5 0.0 0.0 0.0 0.0
Week 24 (n=37,17,34,17,49,61,57,9,44,34,25) 2.7 0.0 5.9 0.0 6.1 14.8 12.3 0.0 0.0 0.0 0.0
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
6.Secondary Outcome
Title Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
Hide Description ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.
Time Frame Baseline up to Week 2, 4, 6, 8, 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. Missing values were imputed using Last Observation Carried Forward (LOCF).
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Placebo
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Overall Number of Participants Analyzed 54 50 49 61 56 53 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -99.17  (430.60) -21.41  (348.60) 36.11  (254.60) 117.91  (236.40) 16.24  (507.70) -82.12  (436.48) -97.56  (362.62)
Week 4 -328.58  (1190.65) -31.17  (1068.34) 165.07  (685.88) 421.90  (700.43) 184.76  (1317.14) -211.66  (1178.51) -268.25  (906.61)
Week 6 -488.95  (2121.82) -7.91  (1840.80) 416.04  (1117.60) 839.12  (1219.16) 584.69  (1864.04) -280.67  (1925.43) -430.41  (1471.10)
Week 8 -545.16  (3121.09) 30.98  (2675.04) 761.40  (1552.54) 1311.99  (1736.67) 1077.41  (2543.43) -331.79  (2727.74) -531.80  (2095.50)
Week 10 -588.77  (4109.74) 81.85  (3510.17) 1163.37  (1985.69) 1857.57  (2203.00) 1539.51  (3768.28) -337.47  (3478.31) -642.56  (2805.90)
Week 12 -675.05  (5160.91) 145.08  (4380.78) 1579.56  (2447.05) 2443.62  (2701.93) 2053.03  (4745.53) -242.83  (4111.62) -803.67  (3548.72)
7.Secondary Outcome
Title Tender Joint Count (TJC)
Hide Description Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 5 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 44 59 25
Mean (Standard Deviation)
Unit of Measure: tender joints
Baseline (n=54,0,51,0,49,61,57,53,0,59,0) 27.02  (15.39) NA [1]   (NA) 24.55  (11.31) NA [1]   (NA) 27.14  (14.62) 25.70  (13.92) 25.88  (13.37) 24.11  (13.86) NA [1]   (NA) 25.92  (12.92) NA [1]   (NA)
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0) 21.98  (14.45) NA [1]   (NA) 16.94  (10.75) NA [1]   (NA) 18.79  (12.42) 15.33  (12.74) 17.42  (14.33) 19.40  (14.76) NA [1]   (NA) 20.00  (11.82) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0) 20.54  (17.43) NA [1]   (NA) 13.83  (11.80) NA [1]   (NA) 17.43  (13.01) 12.84  (12.55) 13.16  (14.95) 16.78  (14.79) NA [1]   (NA) 18.94  (13.30) NA [1]   (NA)
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0) 15.13  (13.52) NA [1]   (NA) 12.67  (12.06) NA [1]   (NA) 14.33  (11.06) 10.95  (11.95) 11.27  (14.89) 15.73  (13.94) NA [1]   (NA) 17.77  (14.45) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) 16.30  (14.14) NA [1]   (NA) 13.40  (12.74) NA [1]   (NA) 13.68  (12.57) 10.00  (11.81) 9.15  (12.18) 14.87  (13.11) NA [1]   (NA) 15.93  (12.33) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) 17.15  (17.32) NA [1]   (NA) 12.65  (11.89) NA [1]   (NA) 11.87  (11.17) 7.68  (10.94) 9.23  (12.88) 14.47  (15.20) NA [1]   (NA) 17.22  (14.38) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) 18.32  (16.77) NA [1]   (NA) 12.33  (12.88) NA [1]   (NA) 11.52  (12.35) 8.09  (12.02) 8.44  (11.26) 14.74  (14.73) NA [1]   (NA) 15.50  (13.14) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25) 7.44  (8.38) 19.47  (14.06) 6.27  (6.49) 19.41  (12.25) 10.85  (11.11) 7.57  (11.08) 7.22  (11.34) NA [2]   (NA) 8.70  (9.47) 8.30  (9.07) 12.40  (12.24)
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25) 10.41  (10.69) 16.19  (9.72) 6.76  (8.25) 18.25  (15.65) 11.80  (12.82) 6.66  (10.62) 6.79  (9.69) NA [2]   (NA) 8.95  (10.56) 8.16  (8.74) 12.60  (13.28)
Week 24 (n=24,16,29,15,43,55,52,0,39,20,24) 11.92  (13.64) 21.31  (14.81) 6.59  (10.58) 16.60  (13.49) 10.47  (11.50) 6.25  (10.12) 7.27  (11.35) NA [2]   (NA) 10.44  (9.97) 8.75  (8.59) 10.54  (13.09)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
8.Secondary Outcome
Title Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET
Hide Description Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 48 60 57 53 44 57 25
Mean (Standard Deviation)
Unit of Measure: tender joints
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0) -5.04  (12.12) NA [1]   (NA) -7.61  (9.31) NA [1]   (NA) -8.23  (12.61) -10.28  (12.57) -8.46  (12.87) -4.72  (10.97) NA [1]   (NA) -6.19  (11.84) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0) -6.56  (14.49) NA [1]   (NA) -10.43  (10.53) NA [1]   (NA) -10.33  (10.76) -13.00  (12.73) -12.85  (14.91) -7.67  (11.40) NA [1]   (NA) -7.23  (11.39) NA [1]   (NA)
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0) -11.96  (15.35) NA [1]   (NA) -11.38  (11.02) NA [1]   (NA) -13.40  (13.50) -14.49  (13.52) -14.38  (14.86) -8.83  (13.02) NA [1]   (NA) -8.69  (13.86) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) -11.83  (13.56) NA [1]   (NA) -10.65  (11.06) NA [1]   (NA) -13.70  (13.86) -15.61  (13.82) -15.57  (13.80) -8.57  (12.44) NA [1]   (NA) -9.67  (11.63) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) -11.07  (16.23) NA [1]   (NA) -11.65  (10.87) NA [1]   (NA) -15.93  (13.92) -17.51  (14.08) -15.77  (12.77) -9.89  (12.54) NA [1]   (NA) -8.72  (13.22) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) -9.57  (15.80) NA [1]   (NA) -11.04  (11.42) NA [1]   (NA) -16.24  (13.32) -16.74  (14.23) -16.28  (12.25) -9.30  (11.96) NA [1]   (NA) -10.43  (14.72) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25) -19.11  (13.88) -10.53  (12.43) -15.03  (9.88) -8.47  (12.51) -16.91  (13.06) -17.48  (13.24) -17.50  (13.29) NA [2]   (NA) -15.09  (12.35) -19.55  (13.02) -12.40  (10.17)
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25) -16.15  (16.26) -13.38  (11.59) -15.28  (11.11) -10.00  (13.23) -15.98  (13.20) -17.53  (12.86) -17.57  (13.62) NA [2]   (NA) -15.18  (11.25) -18.16  (13.00) -12.20  (12.02)
Week 24 (n=24,16,29,15,43,55,52,0,39,20,24) -12.63  (14.37) -8.25  (13.75) -15.45  (13.03) -10.47  (13.60) -17.58  (15.22) -18.42  (13.64) -17.02  (14.14) NA [2]   (NA) -13.10  (12.94) -19.10  (14.88) -14.21  (12.25)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
9.Secondary Outcome
Title Swollen Joint Counts (SJC)
Hide Description Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 44 59 25
Mean (Standard Deviation)
Unit of Measure: swollen joints
Baseline (n=54,0,51,0,49,61,57,53,0,59,0) 16.70  (8.89) NA [1]   (NA) 15.90  (8.50) NA [1]   (NA) 17.35  (10.26) 16.33  (8.28) 16.93  (9.03) 14.91  (8.12) NA [1]   (NA) 16.90  (9.77) NA [1]   (NA)
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0) 11.87  (7.69) NA [1]   (NA) 12.82  (10.23) NA [1]   (NA) 12.27  (8.90) 10.55  (9.13) 11.25  (8.91) 11.58  (9.96) NA [1]   (NA) 13.25  (8.95) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0) 12.78  (13.24) NA [1]   (NA) 10.98  (10.67) NA [1]   (NA) 10.43  (9.15) 8.50  (7.60) 7.55  (8.89) 10.08  (8.75) NA [1]   (NA) 13.11  (9.10) NA [1]   (NA)
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0) 9.58  (9.11) NA [1]   (NA) 10.08  (9.55) NA [1]   (NA) 8.29  (5.77) 7.03  (7.24) 6.55  (8.02) 9.27  (9.52) NA [1]   (NA) 13.44  (11.47) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) 11.11  (11.67) NA [1]   (NA) 9.88  (10.87) NA [1]   (NA) 8.15  (7.46) 7.02  (8.63) 5.91  (7.65) 8.89  (10.84) NA [1]   (NA) 11.37  (9.64) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) 10.63  (10.89) NA [1]   (NA) 9.35  (9.52) NA [1]   (NA) 6.93  (7.11) 5.39  (7.47) 5.68  (7.96) 9.11  (11.81) NA [1]   (NA) 12.76  (11.21) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) 11.39  (11.23) NA [1]   (NA) 9.26  (10.74) NA [1]   (NA) 7.33  (7.15) 5.58  (7.84) 5.11  (7.15) 7.41  (7.83) NA [1]   (NA) 11.85  (9.64) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25) 6.44  (7.29) 10.82  (7.63) 4.50  (5.48) 14.88  (13.15) 5.96  (6.54) 5.34  (7.91) 4.46  (7.64) NA [2]   (NA) 4.56  (5.59) 5.90  (6.02) 9.76  (8.53)
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25) 7.89  (7.95) 10.31  (8.55) 5.03  (7.59) 14.38  (13.99) 6.71  (6.96) 4.60  (7.82) 4.36  (7.17) NA [2]   (NA) 5.52  (7.68) 5.21  (4.50) 7.92  (6.95)
Week 24 (n=24,16,29,15,43,55,52,0,39,20,24) 8.92  (11.01) 10.94  (9.04) 4.86  (7.81) 13.27  (13.01) 5.88  (6.38) 4.44  (7.78) 4.10  (6.83) NA [2]   (NA) 5.67  (7.46) 5.95  (6.26) 6.04  (6.40)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
10.Secondary Outcome
Title Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24
Hide Description Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling = 1. A negative value in change from baseline indicated an improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Initially CP-690,550 3 mg tablet administered orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10. After Week 12, participants were reassigned CP-690,550 5 mg tablet administered orally twice daily.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 10 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 48 60 57 53 44 57 25
Mean (Standard Deviation)
Unit of Measure: swollen joints
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0) -4.83  (7.04) NA [1]   (NA) -3.08  (8.86) NA [1]   (NA) -4.85  (9.65) -5.67  (6.94) -5.68  (9.98) -3.32  (9.25) NA [1]   (NA) -3.74  (8.33) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0) -4.08  (10.31) NA [1]   (NA) -4.66  (9.88) NA [1]   (NA) -6.63  (9.01) -8.02  (7.03) -9.55  (11.00) -4.57  (8.52) NA [1]   (NA) -4.06  (8.76) NA [1]   (NA)
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0) -7.88  (9.28) NA [1]   (NA) -5.54  (9.76) NA [1]   (NA) -8.69  (9.13) -9.36  (7.60) -10.51  (10.61) -5.75  (8.32) NA [1]   (NA) -3.87  (10.53) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) -6.36  (10.05) NA [1]   (NA) -5.75  (9.94) NA [1]   (NA) -8.70  (9.60) -9.19  (7.70) -10.85  (10.60) -6.17  (8.50) NA [1]   (NA) -5.33  (9.12) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) -6.70  (8.60) NA [1]   (NA) -6.33  (9.40) NA [1]   (NA) -9.89  (9.78) -11.11  (7.99) -11.28  (10.79) -6.00  (9.66) NA [1]   (NA) -3.50  (11.31) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) -6.07  (9.67) NA [1]   (NA) -5.85  (10.70) NA [1]   (NA) -9.74  (10.28) -10.91  (8.48) -11.65  (10.26) -7.83  (7.52) NA [1]   (NA) -4.41  (9.89) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25) -11.00  (8.75) -6.65  (9.84) -9.97  (6.98) -1.24  (13.15) -11.11  (9.87) -11.27  (8.86) -12.30  (10.98) NA [2]   (NA) -10.86  (8.03) -10.25  (6.77) -7.00  (11.08)
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25) -9.56  (9.21) -6.06  (9.70) -9.90  (9.32) -2.19  (14.28) -10.40  (10.40) -11.17  (7.92) -12.68  (10.65) NA [2]   (NA) -9.91  (7.50) -11.47  (7.46) -8.84  (9.92)
Week 24 (n=24,16,29,15,43,55,52,0,39,20,24) -8.58  (8.98) -5.44  (9.33) -10.07  (9.70) -1.60  (14.34) -11.60  (11.55) -11.75  (7.82) -13.10  (10.44) NA [2]   (NA) -9.46  (9.37) -10.20  (7.78) -11.00  (11.16)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
11.Secondary Outcome
Title Patient Assessment of Arthritis Pain
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 44 59 25
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=54,0,51,0,49,61,56,53,0,59,0) 59.74  (23.56) NA [1]   (NA) 61.25  (23.93) NA [1]   (NA) 64.14  (23.55) 62.92  (18.74) 63.46  (25.26) 64.36  (21.46) NA [1]   (NA) 60.29  (23.23) NA [1]   (NA)
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0) 53.76  (24.49) NA [1]   (NA) 45.25  (24.19) NA [1]   (NA) 47.10  (24.48) 43.90  (23.43) 41.28  (28.06) 48.00  (25.09) NA [1]   (NA) 55.26  (26.70) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0) 51.72  (24.91) NA [1]   (NA) 41.91  (23.80) NA [1]   (NA) 43.65  (22.56) 33.28  (22.37) 32.69  (23.77) 46.78  (23.85) NA [1]   (NA) 50.89  (23.50) NA [1]   (NA)
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0) 47.31  (24.21) NA [1]   (NA) 42.75  (22.17) NA [1]   (NA) 39.24  (22.73) 33.68  (22.52) 30.24  (25.46) 46.27  (28.16) NA [1]   (NA) 49.63  (24.08) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) 47.28  (25.46) NA [1]   (NA) 41.21  (22.19) NA [1]   (NA) 33.91  (23.56) 33.05  (22.34) 26.74  (26.01) 43.17  (25.22) NA [1]   (NA) 47.26  (23.25) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) 45.70  (26.30) NA [1]   (NA) 43.24  (23.23) NA [1]   (NA) 34.67  (24.34) 28.11  (21.80) 23.38  (22.03) 48.73  (27.32) NA [1]   (NA) 44.96  (24.72) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) 47.25  (25.81) NA [1]   (NA) 42.30  (26.89) NA [1]   (NA) 32.70  (25.23) 28.14  (22.79) 27.26  (25.88) 42.87  (25.76) NA [1]   (NA) 43.93  (24.16) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25) 35.00  (26.63) 49.29  (29.81) 34.97  (29.16) 47.88  (25.87) 31.39  (23.72) 29.05  (26.23) 24.24  (23.60) NA [2]   (NA) 30.16  (21.52) 37.55  (22.42) 28.16  (22.28)
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25) 39.67  (27.28) 43.38  (24.69) 34.66  (29.75) 38.81  (25.45) 33.13  (24.57) 27.43  (23.98) 23.21  (22.60) NA [2]   (NA) 31.68  (22.68) 36.95  (25.80) 31.64  (20.22)
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24) 44.13  (24.32) 44.00  (28.63) 30.62  (28.36) 31.87  (20.47) 31.81  (27.72) 22.85  (22.04) 25.31  (22.28) NA [2]   (NA) 34.33  (24.87) 31.35  (22.51) 29.83  (18.37)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
12.Secondary Outcome
Title Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 48 60 56 53 44 57 25
Mean (Standard Deviation)
Unit of Measure: mm
Week 2 (n=54,0,51,0,48,60,56,53,0,57,0) -5.98  (25.77) NA [1]   (NA) -16.00  (17.89) NA [1]   (NA) -16.33  (20.70) -19.33  (22.50) -23.11  (29.72) -16.36  (23.18) NA [1]   (NA) -5.14  (25.64) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,54,49,0,53,0) -6.78  (30.17) NA [1]   (NA) -19.04  (19.15) NA [1]   (NA) -20.28  (21.33) -28.60  (24.09) -32.41  (29.39) -16.96  (28.05) NA [1]   (NA) -7.89  (23.27) NA [1]   (NA)
Week 6 (n=48,0,48,0,45,59,54,48,0,52,0) -11.42  (28.68) NA [1]   (NA) -17.23  (23.04) NA [1]   (NA) -25.04  (22.63) -28.80  (22.13) -33.50  (29.39) -18.35  (26.77) NA [1]   (NA) -9.08  (22.68) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) -11.68  (29.48) NA [1]   (NA) -18.77  (20.45) NA [1]   (NA) -30.02  (25.59) -29.07  (23.84) -35.83  (30.52) -20.83  (27.49) NA [1]   (NA) -10.28  (23.46) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) -13.98  (27.46) NA [1]   (NA) -17.39  (22.24) NA [1]   (NA) -29.30  (26.46) -34.77  (25.60) -38.94  (29.33) -16.80  (26.12) NA [1]   (NA) -12.63  (21.45) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) -11.61  (31.51) NA [1]   (NA) -16.04  (22.11) NA [1]   (NA) -31.24  (24.72) -34.47  (25.63) -35.31  (31.92) -23.15  (27.70) NA [1]   (NA) -13.65  (24.40) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25) -19.00  (33.30) -17.29  (29.71) -18.73  (25.91) -21.00  (22.29) -32.54  (23.55) -33.77  (27.27) -38.33  (30.31) NA [2]   (NA) -36.37  (22.95) -16.05  (24.30) -33.40  (25.97)
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25) -14.33  (28.92) -22.19  (29.73) -19.66  (25.00) -29.50  (25.80) -31.67  (20.98) -34.66  (23.72) -39.55  (31.04) NA [2]   (NA) -35.09  (27.62) -15.58  (25.51) -29.92  (23.24)
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24) -9.83  (29.65) -21.56  (35.86) -23.69  (24.12) -36.00  (18.57) -32.84  (25.37) -39.69  (22.62) -37.83  (28.84) NA [2]   (NA) -31.48  (28.90) -22.25  (25.21) -31.63  (24.22)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
13.Secondary Outcome
Title Patient Global Assessment (PtGA) of Arthritis Pain
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, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 44 59 25
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=54,0,51,0,49,61,57,53,0,59,0) 60.74  (24.83) NA [1]   (NA) 59.76  (22.75) NA [1]   (NA) 67.55  (22.44) 62.41  (19.94) 62.77  (27.24) 62.15  (21.87) NA [1]   (NA) 61.41  (21.32) NA [1]   (NA)
Week 2 (n=53,0,51,0,48,60,57,53,0,57,0) 54.36  (23.84) NA [1]   (NA) 48.49  (24.49) NA [1]   (NA) 50.58  (24.55) 41.82  (24.09) 42.02  (25.77) 48.00  (24.15) NA [1]   (NA) 58.93  (25.12) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0) 52.96  (23.69) NA [1]   (NA) 44.68  (23.55) NA [1]   (NA) 44.54  (23.10) 34.86  (23.15) 34.73  (25.05) 46.24  (23.10) NA [1]   (NA) 51.40  (23.47) NA [1]   (NA)
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0) 47.08  (23.11) NA [1]   (NA) 41.52  (21.65) NA [1]   (NA) 39.07  (22.47) 33.63  (22.01) 31.09  (25.20) 43.46  (25.41) NA [1]   (NA) 49.71  (22.73) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) 46.57  (27.58) NA [1]   (NA) 43.02  (23.13) NA [1]   (NA) 34.81  (23.95) 33.42  (23.39) 28.07  (26.86) 43.85  (23.60) NA [1]   (NA) 46.74  (23.66) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) 45.80  (27.90) NA [1]   (NA) 43.57  (24.39) NA [1]   (NA) 35.04  (24.26) 29.09  (21.52) 22.72  (23.36) 46.11  (25.71) NA [1]   (NA) 47.24  (24.12) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) 45.39  (26.12) NA [1]   (NA) 40.78  (26.08) NA [1]   (NA) 33.52  (24.26) 29.02  (23.09) 26.39  (26.55) 44.04  (25.24) NA [1]   (NA) 44.85  (23.59) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25) 36.07  (25.88) 52.00  (28.93) 35.03  (29.52) 44.24  (25.78) 30.37  (23.58) 30.71  (25.69) 24.72  (23.11) NA [2]   (NA) 31.33  (18.80) 38.65  (22.37) 32.48  (20.69)
Week 20 (n=27,16,29,16,45,53,52,0,44,19,25) 39.74  (27.72) 47.19  (24.36) 35.41  (29.13) 41.44  (24.86) 33.91  (24.90) 28.06  (23.26) 23.90  (22.38) NA [2]   (NA) 30.95  (21.47) 35.84  (26.21) 36.20  (21.44)
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24) 43.08  (23.92) 45.69  (26.15) 33.07  (27.90) 33.20  (19.77) 33.77  (28.44) 24.85  (22.29) 26.58  (23.04) NA [2]   (NA) 34.45  (23.60) 32.05  (22.63) 28.13  (17.42)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
14.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
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, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 53 17 51 17 48 60 57 53 44 57 25
Mean (Standard Deviation)
Unit of Measure: mm
Week 2 (n=53,0,51,0,48,60,57,53,0,57,0) -5.72  (22.55) NA [1]   (NA) -11.27  (18.57) NA [1]   (NA) -16.33  (26.14) -21.48  (25.18) -20.75  (28.26) -14.15  (25.21) NA [1]   (NA) -2.84  (26.71) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0) -6.62  (28.20) NA [1]   (NA) -15.51  (22.14) NA [1]   (NA) -23.15  (24.65) -26.52  (25.06) -28.29  (28.34) -15.35  (25.66) NA [1]   (NA) -9.64  (22.16) NA [1]   (NA)
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0) -13.58  (29.19) NA [1]   (NA) -17.77  (25.31) NA [1]   (NA) -28.89  (24.62) -28.39  (25.53) -31.49  (29.39) -18.69  (24.71) NA [1]   (NA) -11.27  (18.60) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) -13.79  (27.05) NA [1]   (NA) -16.27  (21.81) NA [1]   (NA) -32.91  (28.68) -28.18  (26.81) -34.11  (29.33) -18.23  (29.39) NA [1]   (NA) -13.24  (19.77) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) -14.70  (26.43) NA [1]   (NA) -16.21  (21.93) NA [1]   (NA) -32.93  (28.11) -33.21  (27.96) -39.25  (28.87) -17.42  (26.53) NA [1]   (NA) -12.93  (22.30) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) -15.05  (29.31) NA [1]   (NA) -16.96  (22.92) NA [1]   (NA) -34.17  (25.62) -33.09  (28.82) -35.80  (30.90) -19.80  (29.70) NA [1]   (NA) -15.33  (22.06) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25) -19.81  (29.62) -15.65  (29.98) -20.60  (24.26) -19.35  (22.34) -37.33  (25.23) -31.50  (28.85) -37.46  (29.80) NA [2]   (NA) -33.19  (25.10) -16.75  (24.67) -32.44  (22.40)
Week 20 (n=27,16,29,16,45,53,52,0,44,19,25) -16.15  (30.54) -19.69  (31.12) -20.38  (23.79) -21.00  (17.74) -34.73  (24.52) -32.87  (24.10) -37.65  (32.14) NA [2]   (NA) -33.64  (28.30) -18.74  (20.40) -28.72  (22.80)
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24) -12.96  (26.46) -21.19  (33.96) -22.72  (25.10) -27.93  (15.08) -34.72  (26.19) -37.31  (25.58) -36.10  (29.30) NA [2]   (NA) -29.33  (34.25) -23.35  (16.74) -36.75  (21.95)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
15.Secondary Outcome
Title Physician Global Assessment (PGA) of Arthritis
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, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 48 60 57 53 44 57 25
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=54,0,50,0,48,60,57,53,0,59,0) 62.13  (16.69) NA [1]   (NA) 62.10  (18.37) NA [1]   (NA) 65.85  (14.36) 61.05  (15.78) 67.19  (17.93) 62.77  (15.18) NA [1]   (NA) 63.02  (18.74) NA [1]   (NA)
Week 2 (n=54,0,51,0,46,60,57,53,0,57,0) 52.30  (21.90) NA [1]   (NA) 47.88  (20.86) NA [1]   (NA) 50.37  (21.90) 39.85  (18.69) 44.98  (21.61) 47.58  (20.95) NA [1]   (NA) 55.19  (19.98) NA [1]   (NA)
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0) 47.30  (20.40) NA [1]   (NA) 41.23  (20.80) NA [1]   (NA) 43.3  (19.49) 34.55  (20.68) 31.89  (20.38) 44.02  (20.06) NA [1]   (NA) 50.15  (20.92) NA [1]   (NA)
Week 6 (n=48,0,47,0,45,59,55,48,0,52,0) 39.75  (21.73) NA [1]   (NA) 34.98  (21.30) NA [1]   (NA) 39.40  (20.40) 31.22  (19.51) 28.56  (21.47) 39.83  (22.75) NA [1]   (NA) 46.12  (24.57) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0) 40.06  (22.39) NA [1]   (NA) 36.54  (23.22) NA [1]   (NA) 31.79  (19.94) 29.56  (18.60) 25.20  (21.85) 38.34  (21.38) NA [1]   (NA) 43.91  (20.78) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) 41.65  (23.12) NA [1]   (NA) 38.78  (24.18) NA [1]   (NA) 33.70  (20.03) 24.72  (18.83) 23.68  (18.76) 40.69  (25.21) NA [1]   (NA) 44.83  (21.34) NA [1]   (NA)
Week 12 (n=43,0,46,0,46,57,54,46,0,46,0) 41.72  (23.11) NA [1]   (NA) 36.65  (23.47) NA [1]   (NA) 29.80  (19.13) 25.37  (20.01) 24.20  (18.74) 38.22  (23.33) NA [1]   (NA) 44.76  (24.90) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,56,53,0,43,20,25) 29.93  (19.58) 48.59  (20.92) 26.97  (23.53) 44.59  (21.99) 29.74  (20.31) 24.39  (19.14) 21.09  (19.71) NA [2]   (NA) 25.74  (15.96) 28.70  (22.76) 34.00  (20.65)
Week 20 (n=27,16,29,16,45,52,53,0,44,19,25) 32.59  (20.17) 45.69  (15.98) 23.86  (20.45) 41.25  (23.77) 27.04  (17.16) 19.35  (14.10) 19.42  (17.92) NA [2]   (NA) 26.36  (17.76) 29.95  (21.31) 32.40  (19.24)
Week 24 (n=24,15,28,15,43,55,51,0,40,20,24) 35.21  (23.91) 41.20  (19.27) 22.50  (23.37) 32.00  (19.13) 30.26  (20.91) 20.13  (16.50) 19.06  (16.73) NA [2]   (NA) 27.05  (17.55) 24.05  (17.75) 29.42  (21.01)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
16.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
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, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 50 17 46 59 57 53 44 57 25
Mean (Standard Deviation)
Unit of Measure: mm
Week 2 (n=54,0,50,0,46,59,57,53,0,57,0) -9.83  (18.32) NA [1]   (NA) -14.24  (19.94) NA [1]   (NA) -14.93  (22.19) -21.14  (20.74) -22.21  (26.01) -15.19  (19.07) NA [1]   (NA) -8.00  (21.96) NA [1]   (NA)
Week 4 (n=50,0,46,0,45,57,55,49,0,53,0) -14.24  (18.08) NA [1]   (NA) -21.93  (22.49) NA [1]   (NA) -22.24  (21.63) -26.61  (23.51) -36.24  (26.36) -18.65  (23.07) NA [1]   (NA) -12.47  (25.24) NA [1]   (NA)
Week 6 (n=48,0,47,0,44,58,55,48,0,52,0) -22.10  (22.45) NA [1]   (NA) -26.70  (23.32) NA [1]   (NA) -26.36  (21.04) -30.48  (22.57) -38.24  (27.62) -23.44  (21.38) NA [1]   (NA) -17.38  (27.00) NA [1]   (NA)
Week 8 (n=47,0,47,0,46,56,54,47,0,46,0) -21.72  (21.14) NA [1]   (NA) -25.53  (24.00) NA [1]   (NA) -33.48  (22.13) -31.88  (21.14) -41.04  (26.88) -24.45  (21.70) NA [1]   (NA) -20.22  (25.40) NA [1]   (NA)
Week 10 (n=46,0,48,0,45,56,53,45,0,46,0) -20.04  (22.75) NA [1]   (NA) -23.31  (24.67) NA [1]   (NA) -32.20  (23.25) -36.93  (23.90) -42.70  (25.85) -23.31  (24.37) NA [1]   (NA) -19.41  (24.91) NA [1]   (NA)
Week 12 (n=43,0,46,0,45,56,54,46,0,46,0) -19.33  (20.91) NA [1]   (NA) -24.57  (23.98) NA [1]   (NA) -35.84  (20.73) -36.50  (22.13) -42.04  (24.60) -25.74  (23.17) NA [1]   (NA) -19.48  (27.84) NA [1]   (NA)
Week 16 (n=27,17,29,17,45,55,53,0,43,20,25) -28.11  (19.93) -18.59  (24.63) -31.24  (31.83) -23.59  (17.14) -35.60  (22.92) -37.87  (21.09) -44.66  (26.28) NA [2]   (NA) -37.28  (19.72) -35.15  (25.29) -29.96  (23.75)
Week 20 (n=27,16,28,16,44,51,53,0,44,19,25) -25.44  (17.89) -20.38  (20.91) -33.29  (28.80) -25.19  (18.46) -38.55  (21.77) -41.49  (18.87) -47.11  (23.87) NA [2]   (NA) -36.86  (20.07) -32.89  (19.37) -31.56  (24.08)
Week 24 (n=24,15,27,15,42,54,51,0,40,20,24) -24.38  (13.92) -24.87  (25.37) -34.78  (32.39) -33.73  (17.12) -35.55  (24.81) -41.59  (18.94) -47.12  (23.42) NA [2]   (NA) -35.83  (22.06) -39.80  (24.35) -35.13  (23.70)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
17.Secondary Outcome
Title C-Reactive Protein (CRP)
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 61 57 53 43 59 25
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline (n=54,0,51,0,49,61,57,53,0,59,0) 21.39  (22.17) NA [1]   (NA) 16.22  (19.53) NA [1]   (NA) 24.51  (30.39) 16.66  (16.85) 21.70  (33.01) 20.09  (23.47) NA [1]   (NA) 23.53  (27.07) NA [1]   (NA)
Week 2 (n=53,0,51,0,48,60,57,52,0,56,0) 16.09  (17.96) NA [1]   (NA) 11.63  (16.13) NA [1]   (NA) 9.33  (17.71) 4.37  (5.98) 6.18  (9.45) 9.54  (13.93) NA [1]   (NA) 31.14  (36.74) NA [1]   (NA)
Week 4 (n=50,0,48,0,45,57,53,49,0,53,0) 16.81  (19.66) NA [1]   (NA) 9.33  (13.20) NA [1]   (NA) 7.32  (10.20) 3.15  (5.93) 5.04  (7.15) 13.74  (19.51) NA [1]   (NA) 26.69  (35.34) NA [1]   (NA)
Week 6 (n=47,0,48,0,45,58,55,48,0,52,0) 15.47  (16.19) NA [1]   (NA) 8.76  (12.52) NA [1]   (NA) 7.73  (9.80) 4.00  (7.25) 4.43  (6.21) 15.47  (21.75) NA [1]   (NA) 27.13  (33.02) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,56,53,47,0,45,0) 21.80  (33.09) NA [1]   (NA) 12.61  (26.98) NA [1]   (NA) 7.22  (11.35) 3.52  (5.82) 4.50  (7.80) 13.60  (18.86) NA [1]   (NA) 27.06  (33.94) NA [1]   (NA)
Week 10 (n=46,0,48,0,46,57,52,45,0,46,0) 15.89  (21.85) NA [1]   (NA) 8.20  (12.04) NA [1]   (NA) 7.49  (10.77) 2.34  (1.90) 3.14  (4.45) 14.31  (18.37) NA [1]   (NA) 29.87  (36.82) NA [1]   (NA)
Week 12 (n=43,0,46,0,45,54,52,45,0,45,0) 16.89  (21.34) NA [1]   (NA) 9.23  (12.64) NA [1]   (NA) 8.13  (12.01) 3.12  (3.48) 3.62  (3.88) 14.53  (20.30) NA [1]   (NA) 37.00  (52.65) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,55,51,0,43,20,25) 11.64  (15.98) 9.86  (18.85) 7.64  (11.06) 9.21  (12.03) 8.03  (16.57) 4.65  (7.38) 4.50  (7.05) NA [2]   (NA) 5.73  (7.66) 21.98  (28.43) 6.04  (7.33)
Week 20 (n=26,16,29,16,45,53,52,0,43,18,25) 8.90  (7.91) 4.02  (3.32) 7.32  (8.75) 7.20  (12.14) 4.72  (4.57) 2.85  (3.81) 5.34  (9.65) NA [2]   (NA) 6.82  (9.21) 17.89  (15.34) 4.65  (5.85)
Week 24 (n=24,16,28,15,41,55,52,0,40,20,24) 12.41  (13.51) 10.51  (18.33) 10.02  (15.12) 5.74  (6.42) 6.31  (7.79) 5.65  (10.51) 2.51  (2.50) NA [2]   (NA) 6.01  (9.02) 18.35  (17.49) 5.39  (8.57)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
18.Secondary Outcome
Title Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 53 17 51 17 48 60 57 52 43 56 25
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 2 (n=53,0,51,0,48,60,57,52,0,56,0) -5.59  (12.00) NA [1]   (NA) -4.59  (11.53) NA [1]   (NA) -15.32  (25.84) -11.77  (16.87) -15.53  (28.18) -10.82  (17.70) NA [1]   (NA) 7.63  (20.15) NA [1]   (NA)
Week 4 (n=50,0,48,0,45,57,53,49,0,53,0) -5.35  (15.23) NA [1]   (NA) -6.84  (13.87) NA [1]   (NA) -16.47  (27.76) -13.88  (15.71) -16.29  (32.42) -6.73  (19.31) NA [1]   (NA) 3.68  (30.09) NA [1]   (NA)
Week 6 (n=47,0,48,0,45,58,55,48,0,52,0) -7.04  (17.82) NA [1]   (NA) -7.46  (15.68) NA [1]   (NA) -18.20  (25.77) -13.09  (18.13) -17.78  (31.72) -5.64  (21.52) NA [1]   (NA) 4.13  (24.29) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,56,53,47,0,45,0) -0.88  (34.23) NA [1]   (NA) -3.61  (29.34) NA [1]   (NA) -17.68  (26.27) -12.70  (16.84) -18.12  (33.97) -7.65  (22.81) NA [1]   (NA) 1.68  (25.86) NA [1]   (NA)
Week 10 (n=46,0,48,0,46,57,52,45,0,46,0) -7.41  (17.95) NA [1]   (NA) -7.97  (16.96) NA [1]   (NA) -17.80  (30.17) -14.46  (17.28) -19.68  (33.41) -7.02  (21.73) NA [1]   (NA) 6.60  (26.07) NA [1]   (NA)
Week 12 (n=43,0,46,0,45,54,52,45,0,45,0) -5.62  (19.89) NA [1]   (NA) -6.79  (18.44) NA [1]   (NA) -15.67  (27.63) -13.28  (16.77) -17.12  (29.92) -7.29  (23.48) NA [1]   (NA) 13.27  (45.76) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,55,51,0,43,20,25) -5.08  (21.05) -21.54  (34.58) -4.63  (17.15) -12.89  (23.41) -15.57  (28.20) -12.54  (19.07) -18.41  (33.75) NA [2]   (NA) -16.19  (25.25) -0.54  (19.76) -18.29  (27.14)
Week 20 (n=26,16,29,16,45,53,52,0,43,18,25) -8.39  (13.06) -25.36  (28.34) -5.33  (17.10) -14.73  (25.04) -19.21  (28.52) -14.08  (17.85) -17.67  (35.23) NA [2]   (NA) -15.09  (25.59) -6.87  (17.01) -19.68  (30.10)
Week 24 (n=24,16,28,15,41,55,52,0,40,20,24) -4.19  (14.90) -18.87  (31.77) -2.25  (20.44) -17.13  (26.10) -19.43  (29.21) -10.50  (19.53) -20.43  (33.71) NA [2]   (NA) -16.00  (25.94) -4.18  (21.73) -19.77  (30.92)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
19.Secondary Outcome
Title Health Assessment Questionnaire-Disability Index (HAQ-DI)
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 49 60 57 53 44 58 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=54,0,51,0,49,60,57,53,0,58,0) 1.57  (0.69) NA [1]   (NA) 1.53  (0.63) NA [1]   (NA) 1.40  (0.73) 1.49  (0.74) 1.62  (0.70) 1.44  (0.64) NA [1]   (NA) 1.54  (0.68) NA [1]   (NA)
Week 2 (n=54,0,51,0,48,60,57,53,0,56,0) 1.45  (0.66) NA [1]   (NA) 1.28  (0.63) NA [1]   (NA) 1.22  (0.73) 1.22  (0.68) 1.26  (0.66) 1.23  (0.68) NA [1]   (NA) 1.49  (0.67) NA [1]   (NA)
Week 4 (n=50,0,46,0,45,57,55,49,0,53,0) 1.45  (0.65) NA [1]   (NA) 1.23  (0.69) NA [1]   (NA) 1.14  (0.67) 1.04  (0.74) 1.08  (0.68) 1.31  (0.77) NA [1]   (NA) 1.38  (0.72) NA [1]   (NA)
Week 6 (n=48,0,48,0,44,59,54,48,0,52,0) 1.30  (0.63) NA [1]   (NA) 1.24  (0.65) NA [1]   (NA) 1.14  (0.71) 1.00  (0.72) 0.93  (0.71) 1.19  (0.83) NA [1]   (NA) 1.31  (0.70) NA [1]   (NA)
Week 8 (n=47,0,48,0,46,57,54,47,0,46,0) 1.29  (0.72) NA [1]   (NA) 1.12  (0.70) NA [1]   (NA) 0.99  (0.65) 0.97  (0.75) 0.86  (0.68) 1.12  (0.75) NA [1]   (NA) 1.24  (0.70) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0) 1.25  (0.77) NA [1]   (NA) 1.20  (0.70) NA [1]   (NA) 0.94  (0.75) 0.86  (0.68) 0.81  (0.71) 1.18  (0.73) NA [1]   (NA) 1.24  (0.68) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0) 1.28  (0.72) NA [1]   (NA) 1.09  (0.72) NA [1]   (NA) 0.94  (0.73) 0.81  (0.68) 0.78  (0.66) 1.13  (0.74) NA [1]   (NA) 1.24  (0.76) NA [1]   (NA)
Week 16 (n=27,17,29,17,46,56,54,0,43,20,25) 1.02  (0.72) 1.34  (0.81) 1.04  (0.79) 1.31  (0.72) 0.91  (0.74) 0.85  (0.72) 0.73  (0.63) NA [2]   (NA) 0.95  (0.67) 1.28  (0.66) 0.86  (0.82)
Week 20 (n=27,16,29,15,45,53,52,0,44,19,25) 1.05  (0.71) 1.20  (0.65) 1.00  (0.78) 1.04  (0.67) 0.96  (0.76) 0.80  (0.75) 0.71  (0.65) NA [2]   (NA) 0.95  (0.71) 1.30  (0.69) 0.82  (0.78)
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24) 1.02  (0.65) 1.29  (0.66) 0.96  (0.83) 1.00  (0.74) 0.95  (0.81) 0.81  (0.73) 0.79  (0.67) NA [2]   (NA) 0.93  (0.65) 1.20  (0.81) 0.69  (0.75)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
20.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 48 59 57 53 44 56 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 (n=54,0,51,0,48,59,57,53,0,56,0) -0.13  (0.41) NA [1]   (NA) -0.25  (0.44) NA [1]   (NA) -0.16  (0.47) -0.27  (0.37) -0.36  (0.63) -0.21  (0.44) NA [1]   (NA) -0.04  (0.40) NA [1]   (NA)
Week 4 (n=50,0,46,0,45,56,55,49,0,52,0) -0.14  (0.62) NA [1]   (NA) -0.30  (0.53) NA [1]   (NA) -0.26  (0.51) -0.44  (0.60) -0.55  (0.61) -0.14  (0.68) NA [1]   (NA) -0.09  (0.67) NA [1]   (NA)
Week 6 (n=48,0,48,0,44,58,54,48,0,51,0) -0.31  (0.48) NA [1]   (NA) -0.28  (0.60) NA [1]   (NA) -0.30  (0.56) -0.49  (0.49) -0.68  (0.73) -0.25  (0.63) NA [1]   (NA) -0.17  (0.46) NA [1]   (NA)
Week 8 (n=47,0,48,0,46,56,54,47,0,45,0) -0.34  (0.56) NA [1]   (NA) -0.40  (0.63) NA [1]   (NA) -0.37  (0.61) -0.54  (0.60) -0.73  (0.66) -0.32  (0.62) NA [1]   (NA) -0.24  (0.51) NA [1]   (NA)
Week 10 (n=46,0,49,0,46,56,53,45,0,45,0) -0.36  (0.51) NA [1]   (NA) -0.34  (0.52) NA [1]   (NA) -0.45  (0.68) -0.59  (0.56) -0.78  (0.67) -0.29  (0.66) NA [1]   (NA) -0.24  (0.52) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,56,54,46,0,45,0) -0.30  (0.51) NA [1]   (NA) -0.42  (0.63) NA [1]   (NA) -0.43  (0.65) -0.63  (0.58) -0.81  (0.71) -0.32  (0.59) NA [1]   (NA) -0.24  (0.52) NA [1]   (NA)
Week 16 (n=27,17,29,17,46,55,54,0,43,20,24) -0.54  (0.63) -0.29  (0.58) -0.46  (0.55) -0.31  (0.54) -0.47  (0.66) -0.60  (0.68) -0.86  (0.67) NA [2]   (NA) -0.49  (0.56) -0.33  (0.52) -0.55  (0.65)
Week 20 (n=27,16,29,15,45,52,52,0,44,19,24) -0.51  (0.73) -0.35  (0.57) -0.49  (0.56) -0.51  (0.69) -0.42  (0.66) -0.62  (0.67) -0.87  (0.68) NA [2]   (NA) -0.50  (0.66) -0.28  (0.39) -0.59  (0.62)
Week 24 (n=24,16,29,15,43,54,52,0,40,20,23) -0.58  (0.67) -0.26  (0.62) -0.53  (0.59) -0.56  (0.75) -0.45  (0.75) -0.63  (0.66) -0.82  (0.67) NA [2]   (NA) -0.53  (0.66) -0.41  (0.60) -0.72  (0.55)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
21.Secondary Outcome
Title Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Hide Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Participants who administered Adalimumab initially were switched to CP-690,550 5 milligram (mg) tablet from Week 12 to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 54 17 51 17 48 59 57 52 43 58 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=54,0,51,0,47,59,57,52,0,58,0) 5.51  (0.88) NA [1]   (NA) 5.37  (0.87) NA [1]   (NA) 5.58  (0.88) 5.46  (0.82) 5.46  (0.96) 5.35  (0.98) NA [1]   (NA) 5.62  (0.87) NA [1]   (NA)
Week 2 (n=53,0,51,0,48,60,57,52,0,56,0) 4.96  (1.11) NA [1]   (NA) 4.60  (1.23) NA [1]   (NA) 4.63  (1.15) 4.16  (0.96) 4.32  (1.09) 4.59  (1.26) NA [1]   (NA) 5.24  (1.03) NA [1]   (NA)
Week 4 (n=50,0,47,0,45,57,53,49,0,53,0) 4.77  (1.25) NA [1]   (NA) 4.16  (1.22) NA [1]   (NA) 4.36  (1.00) 3.71  (1.15) 3.71  (1.09) 4.40  (1.45) NA [1]   (NA) 5.01  (1.13) NA [1]   (NA)
Week 6 (n=47,0,48,0,45,58,55,48,0,52,0) 4.42  (1.17) NA [1]   (NA) 4.02  (1.26) NA [1]   (NA) 4.16  (1.06) 3.45  (1.11) 3.34  (1.29) 4.19  (1.55) NA [1]   (NA) 4.92  (1.35) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,56,53,47,0,45,0) 4.52  (1.27) NA [1]   (NA) 4.00  (1.37) NA [1]   (NA) 4.01  (1.25) 3.37  (1.06) 3.13  (1.21) 4.23  (1.33) NA [1]   (NA) 4.84  (1.24) NA [1]   (NA)
Week 10 (n=46,0,48,0,46,57,52,45,0,46,0) 4.37  (1.46) NA [1]   (NA) 3.92  (1.27) NA [1]   (NA) 3.80  (1.21) 3.06  (0.98) 3.05  (1.18) 4.12  (1.56) NA [1]   (NA) 4.83  (1.36) NA [1]   (NA)
Week 12 (n=43,0,46,0,45,54,52,45,0,45,0) 4.57  (1.51) NA [1]   (NA) 3.96  (1.36) NA [1]   (NA) 3.76  (1.38) 3.11  (1.18) 3.06  (1.13) 4.13  (1.33) NA [1]   (NA) 4.83  (1.42) NA [1]   (NA)
Week 16 (n=27,17,30,17,46,55,51,0,43,20,25) 3.63  (1.35) 4.47  (1.13) 3.30  (1.07) 4.75  (1.16) 3.55  (1.41) 3.06  (1.13) 2.92  (1.14) NA [2]   (NA) 3.32  (1.13) 3.93  (1.22) 4.01  (1.08)
Week 20 (n=26,16,29,16,45,53,52,0,43,18,25) 3.94  (1.40) 4.14  (0.92) 3.26  (1.00) 4.44  (1.32) 3.68  (1.38) 2.85  (1.10) 2.93  (1.20) NA [2]   (NA) 3.33  (1.17) 3.97  (1.08) 3.78  (1.11)
Week 24 (n=24,16,28,15,41,55,52,0,39,20,24) 4.11  (1.26) 4.42  (1.12) 3.11  (1.25) 4.33  (1.28) 3.64  (1.22) 2.92  (1.03) 2.82  (1.17) NA [2]   (NA) 3.40  (1.17) 3.96  (1.36) 3.61  (1.13)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
22.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Hide Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 53 17 51 17 46 58 57 51 43 55 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 (n=53,0,51,0,46,58,57,51,0,55,0) -0.55  (0.91) NA [1]   (NA) -0.77  (0.95) NA [1]   (NA) -0.95  (0.85) -1.28  (0.99) -1.14  (1.03) -0.73  (0.90) NA [1]   (NA) -0.37  (0.80) NA [1]   (NA)
Week 4 (n=50,0,47,0,43,56,53,48,0,52,0) -0.75  (1.05) NA [1]   (NA) -1.17  (1.07) NA [1]   (NA) -1.26  (0.95) -1.75  (1.23) -1.72  (1.27) -0.91  (1.13) NA [1]   (NA) -0.63  (0.97) NA [1]   (NA)
Week 6 (n=47,0,48,0,43,56,55,47,0,51,0) -1.17  (1.00) NA [1]   (NA) -1.31  (1.18) NA [1]   (NA) -1.50  (0.95) -1.99  (1.25) -2.14  (1.44) -1.12  (1.31) NA [1]   (NA) -0.73  (1.17) NA [1]   (NA)
Week 8 (n=47,0,48,0,45,54,53,46,0,44,0) -1.09  (1.07) NA [1]   (NA) -1.34  (1.23) NA [1]   (NA) -1.60  (1.09) -2.05  (1.13) -2.31  (1.44) -1.08  (1.23) NA [1]   (NA) -0.84  (1.14) NA [1]   (NA)
Week 10 (n=46,0,48,0,44,56,52,44,0,45,0) -1.24  (1.13) NA [1]   (NA) -1.43  (1.13) NA [1]   (NA) -1.87  (1.18) -2.40  (1.12) -2.41  (1.25) -1.23  (1.24) NA [1]   (NA) -0.76  (1.21) NA [1]   (NA)
Week 12 (n=43,0,46,0,43,53,52,44,0,44,0) -1.04  (1.26) NA [1]   (NA) -1.36  (1.20) NA [1]   (NA) -1.87  (1.29) -2.29  (1.25) -2.37  (1.26) -1.18  (1.12) NA [1]   (NA) -0.80  (1.33) NA [1]   (NA)
Week 16 (n=27,17,30,17,44,54,51,0,43,20,24) -1.83  (1.25) -1.36  (1.07) -1.80  (1.19) -0.95  (0.96) -2.05  (1.33) -2.41  (1.20) -2.49  (1.31) NA [2]   (NA) -2.01  (1.12) -1.73  (1.19) -1.54  (1.16)
Week 20 (n=26,16,29,16,43,52,52,0,43,18,24) -1.52  (1.39) -1.61  (1.23) -1.96  (1.18) -1.25  (1.13) -1.96  (1.33) -2.54  (1.17) -2.52  (1.40) NA [2]   (NA) -2.01  (1.07) -1.77  (0.91) -1.76  (1.27)
Week 24 (n=24,16,28,15,39,54,52,0,39,20,23) -1.27  (1.22) -1.33  (1.36) -2.08  (1.34) -1.28  (1.02) -2.07  (1.24) -2.51  (1.20) -2.62  (1.47) NA [2]   (NA) -1.94  (1.29) -1.71  (1.26) -2.04  (1.43)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
23.Secondary Outcome
Title Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Hide Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 51 17 50 17 47 60 54 51 43 56 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=49,0,49,0,47,59,54,51,0,56,0) 6.51  (0.90) NA [1]   (NA) 6.35  (0.95) NA [1]   (NA) 6.57  (0.87) 6.46  (0.85) 6.46  (0.95) 6.30  (0.97) NA [1]   (NA) 6.56  (0.95) NA [1]   (NA)
Week 2 (n=51,0,50,0,47,60,54,51,0,53,0) 5.92  (1.20) NA [1]   (NA) 5.57  (1.30) NA [1]   (NA) 5.61  (1.34) 5.20  (1.07) 5.20  (1.29) 5.53  (1.33) NA [1]   (NA) 6.04  (1.15) NA [1]   (NA)
Week 4 (n=49,0,46,0,46,57,53,46,0,51,0) 5.73  (1.25) NA [1]   (NA) 5.10  (1.48) NA [1]   (NA) 5.23  (1.09) 4.69  (1.31) 4.46  (1.43) 5.22  (1.52) NA [1]   (NA) 5.70  (1.30) NA [1]   (NA)
Week 6 (n=46,0,47,0,45,58,54,47,0,51,0) 5.36  (1.10) NA [1]   (NA) 4.91  (1.55) NA [1]   (NA) 4.90  (1.19) 4.33  (1.32) 4.02  (1.57) 4.99  (1.70) NA [1]   (NA) 5.64  (1.39) NA [1]   (NA)
Week 8 (n=47,0,48,0,47,56,54,46,0,44,0) 5.31  (1.46) NA [1]   (NA) 4.89  (1.50) NA [1]   (NA) 4.70  (1.24) 4.22  (1.18) 3.80  (1.45) 5.01  (1.42) NA [1]   (NA) 5.56  (1.40) NA [1]   (NA)
Week 10 (n=46,0,49,0,45,56,53,43,0,44,0) 5.22  (1.55) NA [1]   (NA) 4.81  (1.52) NA [1]   (NA) 4.50  (1.31) 3.93  (1.17) 3.71  (1.31) 4.98  (1.72) NA [1]   (NA) 5.54  (1.53) NA [1]   (NA)
Week 12 (n=44,0,46,0,46,56,53,45,0,45,0) 5.41  (1.56) NA [1]   (NA) 4.78  (1.64) NA [1]   (NA) 4.37  (1.43) 3.95  (1.38) 3.77  (1.32) 5.00  (1.50) NA [1]   (NA) 5.39  (1.57) NA [1]   (NA)
Week 16 (n=27,17,30,17,45,55,54,0,42,20,24) 4.39  (1.33) 5.36  (1.23) 3.96  (1.31) 5.70  (1.22) 4.25  (1.47) 3.86  (1.36) 3.63  (1.39) NA [2]   (NA) 4.08  (1.19) 4.53  (1.34) 4.95  (1.30)
Week 20 (n=26,16,29,16,45,51,52,0,43,19,24) 4.76  (1.50) 5.22  (0.93) 4.08  (1.30) 5.31  (1.37) 4.47  (1.47) 3.67  (1.39) 3.54  (1.29) NA [2]   (NA) 4.04  (1.35) 4.47  (1.50) 4.62  (1.27)
Week 24 (n=24,16,29,15,43,54,51,0,38,20,23) 4.87  (1.43) 5.27  (1.42) 3.72  (1.58) 5.19  (1.23) 4.33  (1.40) 3.62  (1.26) 3.61  (1.31) NA [2]   (NA) 4.22  (1.26) 4.51  (1.41) 4.28  (1.20)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
24.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Hide Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR [mm/hour] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 48 15 49 16 45 58 52 50 42 53 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 (n=48,0,49,0,45,58,52,50,0,53,0) -0.56  (1.01) NA [1]   (NA) -0.81  (1.01) NA [1]   (NA) -0.98  (0.88) -1.32  (1.05) -1.27  (1.28) -0.82  (1.00) NA [1]   (NA) -0.53  (1.02) NA [1]   (NA)
Week 4 (n=46,0,45,0,44,55,51,45,0,50,0) -0.82  (1.15) NA [1]   (NA) -1.29  (1.27) NA [1]   (NA) -1.31  (0.89) -1.81  (1.32) -1.95  (1.50) -1.14  (1.26) NA [1]   (NA) -0.87  (1.09) NA [1]   (NA)
Week 6 (n=43,0,46,0,43,56,52,46,0,49,0) -1.26  (1.19) NA [1]   (NA) -1.41  (1.42) NA [1]   (NA) -1.67  (0.97) -2.16  (1.40) -2.39  (1.58) -1.29  (1.37) NA [1]   (NA) -0.97  (1.22) NA [1]   (NA)
Week 8 (n=43,0,46,0,45,54,52,45,0,42,0) -1.30  (1.35) NA [1]   (NA) -1.40  (1.36) NA [1]   (NA) -1.84  (0.99) -2.28  (1.21) -2.63  (1.56) -1.29  (1.33) NA [1]   (NA) -1.00  (1.19) NA [1]   (NA)
Week 10 (n=42,0,47,0,43,54,51,42,0,42,0) -1.37  (1.29) NA [1]   (NA) -1.48  (1.26) NA [1]   (NA) -2.05  (1.28) -2.55  (1.30) -2.78  (1.42) -1.37  (1.31) NA [1]   (NA) -1.00  (1.29) NA [1]   (NA)
Week 12 (n=40,0,44,0,44,54,51,44,0,43,0) -1.16  (1.44) NA [1]   (NA) -1.52  (1.43) NA [1]   (NA) -2.16  (1.32) -2.55  (1.46) -2.65  (1.41) -1.35  (1.29) NA [1]   (NA) -1.17  (1.40) NA [1]   (NA)
Week 16 (n=25,15,29,16,43,53,52,0,41,20,22) -1.97  (1.42) -1.51  (1.08) -2.06  (1.38) -1.18  (0.93) -2.30  (1.29) -2.63  (1.37) -2.83  (1.53) NA [2]   (NA) -2.29  (1.15) -1.97  (1.28) -1.63  (0.93)
Week 20 (n=24,15,28,15,43,49,50,0,42,19,22) -1.54  (1.58) -1.58  (1.34) -2.02  (1.37) -1.47  (1.15) -2.02  (1.34) -2.68  (1.29) -2.88  (1.46) NA [2]   (NA) -2.33  (1.28) -2.03  (1.11) -1.91  (1.03)
Week 24 (n=22,15,28,14,41,52,49,0,37,20,21) -1.33  (1.46) -1.58  (1.58) -2.38  (1.50) -1.51  (1.04) -2.24  (1.31) -2.79  (1.37) -2.78  (1.52) NA [2]   (NA) -2.08  (1.32) -1.99  (1.27) -2.30  (1.24)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
25.Secondary Outcome
Title Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)
Hide Description Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.
Time Frame Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Overall Number of Participants Analyzed 51 17 50 17 47 60 54 51 43 53 24
Measure Type: Number
Unit of Measure: percentage of participants
Week 2: Good (n=51,0,50,0,47,60,54,51,0,53,0) 3.9 NA [1]  2.0 NA [1]  4.3 3.3 7.4 3.9 NA [1]  0.0 NA [1] 
Week 2: Mod (n=51,0,50,0,47,60,54,51,0,53,0) 13.7 NA [1]  28.0 NA [1]  31.9 53.3 42.6 39.2 NA [1]  26.4 NA [1] 
Week 2: None (n=51,0,50,0,47,60,54,51,0,53,0) 76.5 NA [1]  68.0 NA [1]  59.6 40.0 46.3 54.9 NA [1]  73.6 NA [1] 
Week 4: Good (n=49,0,46,0,46,57,53,46,0,51,0) 2.0 NA [1]  10.9 NA [1]  2.2 14.0 17.0 10.9 NA [1]  2.0 NA [1] 
Week 4: Mod (n=49,0,46,0,46,57,53,46,0,51,0) 28.6 NA [1]  43.5 NA [1]  56.5 52.6 50.9 43.5 NA [1]  41.2 NA [1] 
Week 4: None (n=49,0,46,0,46,57,53,46,0,51,0) 63.3 NA [1]  43.5 NA [1]  37.0 29.8 28.3 43.5 NA [1]  54.9 NA [1] 
Week 6: Good (n=46,0,47,0,45,58,54,47,0,51,0) 2.2 NA [1]  14.9 NA [1]  2.2 22.4 29.6 14.9 NA [1]  3.9 NA [1] 
Week 6: Mod (n=46,0,47,0,45,58,54,47,0,51,0) 47.8 NA [1]  46.8 NA [1]  66.7 53.4 50.0 42.6 NA [1]  41.2 NA [1] 
Week 6: None (n=46,0,47,0,45,58,54,47,0,51,0) 43.5 NA [1]  36.2 NA [1]  26.7 20.7 16.7 40.4 NA [1]  51.0 NA [1] 
Week 8: Good (n=47,0,48,0,47,56,54,46,0,44,0) 6.4 NA [1]  12.5 NA [1]  8.5 17.9 37.0 10.9 NA [1]  6.8 NA [1] 
Week 8: Mod (n=47,0,48,0,47,56,54,46,0,44,0) 44.7 NA [1]  43.8 NA [1]  68.1 64.3 40.7 43.5 NA [1]  36.4 NA [1] 
Week 8: None (n=47,0,48,0,47,56,54,46,0,44,0) 40.4 NA [1]  39.6 NA [1]  19.1 14.3 18.5 43.5 NA [1]  52.3 NA [1] 
Week 10: Good (n=46,0,49,0,45,56,53,43,0,44,0) 8.7 NA [1]  10.2 NA [1]  15.6 25.0 41.5 9.3 NA [1]  2.3 NA [1] 
Week 10: Mod (n=46,0,49,0,45,56,53,43,0,44,0) 45.7 NA [1]  55.1 NA [1]  57.8 60.7 45.3 46.5 NA [1]  45.5 NA [1] 
Week 10: None (n=46,0,49,0,45,56,53,43,0,44,0) 37.0 NA [1]  30.6 NA [1]  22.2 10.7 9.4 41.9 NA [1]  47.7 NA [1] 
Week 12: Good (n=44,0,46,0,46,56,53,45,0,45,0) 9.1 NA [1]  15.2 NA [1]  21.7 32.1 37.7 11.1 NA [1]  6.7 NA [1] 
Week 12: Mod (n=44,0,46,0,46,56,53,45,0,45,0) 31.8 NA [1]  43.5 NA [1]  54.3 50.0 47.2 42.2 NA [1]  42.2 NA [1] 
Week 12: None (n=44,0,46,0,46,56,53,45,0,45,0) 50.0 NA [1]  37.0 NA [1]  19.6 14.3 11.3 44.4 NA [1]  46.7 NA [1] 
Week 16: Good (n=27,17,30,17,45,55,54,0,42,20,24) 18.5 5.9 26.7 5.9 22.2 32.7 44.4 NA [2]  23.8 20.0 8.3
Week 16: Mod (n=27,17,30,17,45,55,54,0,42,20,24) 44.4 52.9 50.0 35.3 60.0 52.7 40.7 NA [2]  61.9 50.0 54.2
Week 16: None (n=27,17,30,17,45,55,54,0,42,20,24) 29.6 29.4 20.0 52.9 13.3 10.9 11.1 NA [2]  11.9 30.0 29.2
Week 20: Good (n=26,16,29,16,45,51,52,0,43,19,24) 11.5 0.0 27.6 0.0 20.0 37.3 38.5 NA [2]  27.9 26.3 12.5
Week 20: Mod (n=26,16,29,16,45,51,52,0,43,19,24) 42.3 56.3 55.2 62.5 48.9 52.9 48.1 NA [2]  60.5 47.4 62.5
Week 20: None (n=26,16,29,16,45,51,52,0,43,19,24) 38.5 37.5 13.8 31.3 26.7 5.9 9.6 NA [2]  9.3 26.3 16.7
Week 24: Good (n=24,16,29,15,43,54,51,0,38,20,23) 12.5 12.5 41.4 6.7 20.9 38.9 43.1 NA [2]  23.7 20.0 8.7
Week 24: Mod (n=24,16,29,15,43,54,51,0,38,20,23) 37.5 43.8 41.4 60.0 58.1 48.1 45.1 NA [2]  57.9 60.0 65.2
Week 24: None (n=24,16,29,15,43,54,51,0,38,20,23) 41.7 37.5 13.8 26.7 16.3 9.3 7.8 NA [2]  15.8 20.0 17.4
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
[2]
Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.
26.Secondary Outcome
Title Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)
Hide Description CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).
Time Frame Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Adalimumab Adalimumab to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)