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Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00413660
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : January 8, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: CP-690,550
Other: placebo
Enrollment 509
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 CP-690,550 20 mg 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) CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks. Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 CP-690,550 20 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 71 68 71 75 75 80 69 0 0 0 0
Treated 70 68 71 74 75 80 69 0 0 0 0
Completed 64 61 64 67 66 70 58 0 0 0 0
Not Completed 7 7 7 8 9 10 11 0 0 0 0
Reason Not Completed
Adverse Event             1             3             1             4             6             4             1             0             0             0             0
Lack of Efficacy             2             0             0             0             0             0             5             0             0             0             0
Lost to Follow-up             0             1             0             0             1             0             0             0             0             0             0
Withdrawal by Subject             0             2             0             2             0             2             2             0             0             0             0
Randomized, Not Treated             1             0             0             1             0             0             0             0             0             0             0
Other             3             1             6             1             2             4             3             0             0             0             0
Period Title: Post Week 12
Started 43 48 64 67 66 57 40 21 13 13 18
Completed 40 44 56 66 60 54 37 21 13 12 17
Not Completed 3 4 8 1 6 3 3 0 0 1 1
Reason Not Completed
Adverse Event             2             0             2             1             4             2             2             0             0             0             0
Lack of Efficacy             0             0             1             0             0             0             0             0             0             1             0
Lost to Follow-up             0             1             1             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             1             1             0             1             0             0             0             0             0             1
Other             1             2             3             0             1             1             1             0             0             0             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 CP-690,550 20 mg Placebo Total
Hide Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. 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 for 24 weeks. 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 for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks. Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 5 mg (R) treatment arm for next 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 70 68 71 74 75 80 69 507
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 68 participants 71 participants 74 participants 75 participants 80 participants 69 participants 507 participants
18 to 44 Years 15 23 19 9 14 15 17 112
45 to 64 Years 47 31 42 49 49 49 40 307
Greater Than or Equal to (>=) 65 Years 8 14 10 16 12 16 12 88
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 68 participants 71 participants 74 participants 75 participants 80 participants 69 participants 507 participants
Female
57
  81.4%
52
  76.5%
57
  80.3%
55
  74.3%
66
  88.0%
63
  78.8%
56
  81.2%
406
  80.1%
Male
13
  18.6%
16
  23.5%
14
  19.7%
19
  25.7%
9
  12.0%
17
  21.3%
13
  18.8%
101
  19.9%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Hide Description ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
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 treatment. Missing values were imputed using Baseline Observation Carried Forward (BOCF).
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 CP-690,550 20 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 5 mg (R) treatment arm for next 12 weeks.
Overall Number of Participants Analyzed 70 68 71 74 75 80 69
Measure Type: Number
Unit of Measure: percentage of participants
47.14 55.88 56.34 58.11 56.00 56.25 36.23
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, 16, 20, 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 treatment. Missing values were imputed using BOCF. Here “n” is 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 80 13 69 18
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=70,0,68,0,71,74,75,80,0,69,0) 21.43 NA [1]  36.76 NA [1]  30.99 31.08 40.00 33.75 NA [1]  15.94 NA [1] 
Week 4 (n=70,0,68,0,71,74,75,80,0,69,0) 37.14 NA [1]  45.59 NA [1]  46.48 45.95 54.67 51.25 NA [1]  24.64 NA [1] 
Week 6 (n=70,0,68,0,71,74,75,80,0,69,0) 44.29 NA [1]  54.41 NA [1]  57.75 55.41 56.00 50.00 NA [1]  37.68 NA [1] 
Week 8 (n=70,0,68,0,71,74,75,80,0,69,0) 50.00 NA [1]  54.41 NA [1]  54.93 56.76 64.00 56.25 NA [1]  33.33 NA [1] 
Week 16 (n=49,21,55,13,71,74,75,67,13,51,18) 63.3 0.0 60.0 0.0 53.5 64.9 62.7 64.2 0.0 43.1 0.0
Week 20 (n=49,21,55,13,71,74,75,67,13,51,18) 59.2 0.0 67.3 0.0 57.7 62.2 61.3 64.2 0.0 47.1 0.0
Week 24 (n=49,21,55,13,71,74,75,67,13,51,18) 59.2 0.0 65.5 0.0 59.2 66.2 65.3 62.7 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, 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 treatment. Missing values were imputed using BOCF. Here “n” is 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 80 13 69 18
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=70,0,68,0,71,74,75,80,0,69,0) 1.43 NA [1]  5.88 NA [1]  5.63 4.05 17.33 15.00 NA [1]  2.90 NA [1] 
Week 4 (n=70,0,68,0,71,74,75,80,0,69,0) 4.29 NA [1]  16.18 NA [1]  11.27 20.27 26.67 25.00 NA [1]  2.90 NA [1] 
Week 6 (n=70,0,68,0,71,74,75,80,0,69,0) 10.00 NA [1]  29.41 NA [1]  30.99 27.03 32.00 27.50 NA [1]  8.70 NA [1] 
Week 8 (n=70,0,68,0,71,74,75,80,0,69,0) 17.14 NA [1]  32.35 NA [1]  32.39 28.38 41.33 32.50 NA [1]  17.39 NA [1] 
Week 12 (n=70,0,68,0,71,74,75,80,0,69,0) 22.86 NA [1]  29.41 NA [1]  36.62 28.38 44.00 36.25 NA [1]  17.39 NA [1] 
Week 16 (n=49,21,55,13,71,74,75,67,13,51,18) 38.8 0.0 43.6 0.0 38.0 36.5 40.0 41.8 0.0 21.6 0.0
Week 20 (n=49,21,55,13,71,74,75,67,13,51,18) 38.8 0.0 45.5 0.0 38.0 40.5 48.0 47.8 0.0 31.4 0.0
Week 24 (n=49,21,55,13,71,74,75,67,13,51,18) 44.9 0.0 34.5 0.0 39.4 39.2 46.7 46.3 0.0 31.4 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, 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 treatment. Missing values were imputed using BOCF. Here “n” is 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 80 13 69 18
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=70,0,68,0,71,74,75,80,0,69,0) 1.43 NA [1]  1.47 NA [1]  1.41 1.35 6.67 2.50 NA [1]  0.00 NA [1] 
Week 4 (n=70,0,68,0,71,74,75,80,0,69,0) 2.86 NA [1]  7.35 NA [1]  0.00 14.86 13.33 12.50 NA [1]  1.45 NA [1] 
Week 6 (n=70,0,68,0,71,74,75,80,0,69,0) 1.43 NA [1]  13.24 NA [1]  16.90 9.46 16.00 12.50 NA [1]  4.35 NA [1] 
Week 8 (n=70,0,68,0,71,74,75,80,0,69,0) 8.57 NA [1]  14.71 NA [1]  11.27 16.22 16.00 17.50 NA [1]  5.80 NA [1] 
Week 12 (n=70,0,68,0,71,74,75,80,0,69,0) 4.29 NA [1]  20.59 NA [1]  18.31 12.16 24.00 23.75 NA [1]  5.80 NA [1] 
Week 16 (n=49,21,55,13,71,74,75,67,13,51,18) 16.3 0.0 21.8 0.0 18.3 18.9 24.0 22.4 0.0 9.8 0.0
Week 20 (n=49,21,55,13,71,74,75,67,13,51,18) 20.4 0.0 29.1 0.0 23.9 24.3 28.0 28.4 0.0 13.7 0.0
Week 24 (n=49,21,55,13,71,74,75,67,13,51,18) 28.6 0.0 23.6 0.0 21.1 18.9 32.0 28.4 0.0 9.8 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 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. The 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, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. 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 CP-690,550 20 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 mg tablet orally twice daily for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 5 mg (R) treatment arm for next 12 weeks.
Overall Number of Participants Analyzed 70 68 71 74 75 80 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -14.07  (247.36) 22.16  (243.19) 4.47  (319.92) -21.34  (661.05) 88.72  (287.91) 36.55  (267.26) -113.31  (429.17)
Week 4 61.66  (622.43) 163.40  (659.05) 92.24  (919.49) 7.29  (2038.26) 341.52  (820.16) 170.23  (825.49) -296.38  (1270.69)
Week 6 244.11  (948.25) 442.29  (1087.57) 348.96  (1446.07) 111.83  (3626.48) 716.69  (1285.36) 402.21  (1428.69) -453.18  (2265.12)
Week 8 464.42  (1424.59) 772.65  (1594.84) 693.90  (1952.07) 239.54  (5389.58) 1154.14  (1733.13) 725.67  (1954.96) -571.99  (3310.17)
Week 12 995.34  (2349.99) 1511.40  (2711.76) 1420.20  (3284.51) 588.45  (8969.29) 1974.18  (3231.70) 1504.58  (2979.75) -755.22  (5107.45)
6.Secondary Outcome
Title Tender Joints 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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 80 12 69 17
Mean (Standard Deviation)
Unit of Measure: tender joints
Baseline (n=70,0,68,0,71,74,75,80,0,69,0) 23.64  (11.60) NA [1]   (NA) 22.79  (10.57) NA [1]   (NA) 21.46  (12.95) 24.84  (12.51) 23.68  (12.71) 23.11  (12.67) NA [1]   (NA) 21.59  (13.18) NA [1]   (NA)
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0) 18.62  (12.09) NA [1]   (NA) 17.71  (11.87) NA [1]   (NA) 15.56  (10.44) 17.34  (12.13) 16.32  (13.18) 15.33  (12.59) NA [1]   (NA) 18.86  (13.00) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0) 15.01  (11.19) NA [1]   (NA) 12.80  (10.36) NA [1]   (NA) 13.06  (11.59) 14.01  (14.73) 13.00  (12.48) 13.75  (13.08) NA [1]   (NA) 16.17  (12.36) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0) 14.48  (12.18) NA [1]   (NA) 11.12  (9.56) NA [1]   (NA) 10.23  (10.44) 13.55  (14.38) 11.51  (12.67) 13.22  (13.25) NA [1]   (NA) 14.74  (13.86) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0) 14.24  (12.50) NA [1]   (NA) 10.18  (10.30) NA [1]   (NA) 9.82  (11.08) 12.22  (13.75) 9.49  (11.71) 11.15  (13.76) NA [1]   (NA) 13.57  (14.16) NA [1]   (NA)
Week 12 (n=64,0,59,0,64,66,66,70,0,61,0) 12.84  (12.79) NA [1]   (NA) 8.83  (9.61) NA [1]   (NA) 10.09  (11.65) 10.88  (12.79) 10.18  (12.65) 11.27  (13.68) NA [1]   (NA) 13.77  (14.84) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16) 8.07  (9.11) 19.33  (15.70) 6.02  (7.97) 19.15  (16.42) 8.64  (12.25) 9.77  (12.49) 8.39  (11.32) 7.07  (8.86) 26.25  (19.07) 8.51  (7.25) 15.56  (18.52)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17) 8.08  (11.06) 13.76  (12.02) 5.32  (6.35) 15.00  (11.47) 7.16  (9.91) 8.27  (11.32) 6.98  (9.96) 6.51  (10.55) 23.00  (16.59) 7.62  (7.26) 15.24  (17.68)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17) 7.45  (10.88) 14.80  (14.09) 5.52  (5.65) 13.92  (9.93) 6.85  (9.51) 8.20  (9.94) 6.37  (8.72) 5.87  (7.68) 21.67  (13.69) 5.33  (5.74) 15.88  (17.46)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
7.Secondary Outcome
Title Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/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 indicates an improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 68 21 68 13 68 73 73 79 12 66 17
Mean (Standard Deviation)
Unit of Measure: tender joints
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0) -4.68  (7.26) NA [1]   (NA) -5.09  (9.91) NA [1]   (NA) -6.06  (9.36) -7.62  (8.48) -7.68  (10.20) -7.78  (9.67) NA [1]   (NA) -2.27  (7.50) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0) -8.28  (8.68) NA [1]   (NA) -10.26  (9.63) NA [1]   (NA) -8.42  (9.73) -10.77  (10.25) -10.90  (11.13) -9.59  (10.42) NA [1]   (NA) -5.03  (10.05) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0) -8.86  (10.26) NA [1]   (NA) -11.78  (10.82) NA [1]   (NA) -11.01  (9.64) -11.07  (9.94) -12.14  (10.07) -10.58  (9.60) NA [1]   (NA) -6.69  (11.68) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0) -9.08  (10.79) NA [1]   (NA) -12.69  (11.57) NA [1]   (NA) -11.50  (9.06) -11.93  (10.92) -13.76  (11.73) -12.26  (9.96) NA [1]   (NA) -7.03  (13.26) NA [1]   (NA)
Week 12 (n=64,0,59,0,64,66,66,70,0,61,0) -10.67  (10.73) NA [1]   (NA) -14.00  (12.56) NA [1]   (NA) -10.88  (11.01) -13.47  (9.96) -14.24  (11.80) -12.77  (10.92) NA [1]   (NA) -6.84  (12.84) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16) -14.05  (9.97) -6.81  (7.90) -17.44  (10.54) -1.00  (14.29) -12.93  (12.63) -14.58  (11.19) -15.05  (11.31) -15.65  (9.29) -2.33  (15.69) -10.16  (9.92) -8.06  (10.88)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17) -13.64  (10.63) -12.38  (10.61) -18.36  (9.52) -5.15  (11.07) -14.58  (11.94) -16.08  (10.43) -16.64  (10.73) -15.67  (9.33) -5.58  (11.32) -11.05  (11.86) -8.24  (11.19)
Week 24 (n=40,21,44,13,55,64,60,53,12,36,17) -14.53  (10.83) -10.40  (11.27) -18.16  (9.82) -6.23  (10.54) -14.93  (11.72) -16.36  (9.39) -17.03  (10.39) -16.36  (10.60) -6.92  (12.62) -13.17  (9.90) -7.59  (12.39)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
8.Secondary Outcome
Title Swollen Joints Count (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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 80 12 69 17
Mean (Standard Deviation)
Unit of Measure: swollen joints
Baseline (n=70,0,68,0,71,74,75,80,0,69,0) 16.51  (8.24) NA [1]   (NA) 15.68  (8.56) NA [1]   (NA) 14.06  (7.44) 14.74  (7.46) 15.33  (7.02) 15.21  (8.04) NA [1]   (NA) 15.72  (8.83) NA [1]   (NA)
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0) 12.62  (7.81) NA [1]   (NA) 10.97  (9.02) NA [1]   (NA) 9.51  (6.30) 10.14  (7.92) 10.07  (7.29) 10.14  (6.26) NA [1]   (NA) 13.41  (9.47) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0) 9.85  (7.74) NA [1]   (NA) 8.58  (8.20) NA [1]   (NA) 8.01  (7.45) 7.53  (6.98) 7.85  (6.70) 8.61  (7.16) NA [1]   (NA) 11.11  (8.58) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0) 8.77  (6.34) NA [1]   (NA) 7.23  (7.28) NA [1]   (NA) 6.22  (6.00) 7.10  (7.62) 6.60  (6.31) 7.66  (7.43) NA [1]   (NA) 10.39  (9.24) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0) 8.20  (7.84) NA [1]   (NA) 6.63  (7.63) NA [1]   (NA) 5.35  (5.03) 6.78  (7.43) 6.01  (6.22) 7.22  (8.60) NA [1]   (NA) 8.16  (8.02) NA [1]   (NA)
Week 12 (n=64,0,59,0,64,66,66,70,0,61,0) 8.31  (8.41) NA [1]   (NA) 5.36  (6.64) NA [1]   (NA) 6.13  (6.82) 5.50  (5.84) 4.85  (6.04) 6.80  (8.87) NA [1]   (NA) 8.79  (9.10) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16) 5.83  (7.43) 8.90  (7.55) 3.49  (3.78) 10.00  (10.51) 3.84  (4.40) 4.74  (5.64) 4.26  (5.40) 3.58  (3.54) 14.50  (12.99) 5.97  (5.98) 8.63  (7.70)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17) 4.95  (7.82) 7.33  (8.75) 3.36  (5.19) 8.54  (9.85) 3.95  (5.80) 4.21  (5.59) 3.27  (4.02) 3.31  (4.19) 12.25  (8.25) 5.00  (6.65) 7.41  (9.27)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17) 4.10  (4.83) 8.65  (8.77) 3.73  (5.35) 7.00  (7.14) 3.71  (4.33) 4.41  (6.86) 3.03  (3.75) 2.89  (2.97) 11.25  (9.81) 4.11  (3.90) 7.94  (8.90)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
9.Secondary Outcome
Title Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
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 indicates an improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 68 21 68 13 68 73 73 79 12 66 17
Mean (Standard Deviation)
Unit of Measure: swollen joints
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0) -3.43  (5.98) NA [1]   (NA) -4.71  (7.40) NA [1]   (NA) -4.24  (6.33) -4.75  (5.57) -5.45  (7.74) -5.04  (7.45) NA [1]   (NA) -2.12  (5.00) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0) -6.19  (6.50) NA [1]   (NA) -7.25  (8.80) NA [1]   (NA) -5.97  (5.44) -7.34  (6.27) -7.64  (6.77) -6.74  (8.13) NA [1]   (NA) -4.56  (5.61) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0) -7.41  (6.58) NA [1]   (NA) -8.42  (9.28) NA [1]   (NA) -7.68  (6.30) -7.68  (7.35) -8.68  (6.73) -7.97  (7.54) NA [1]   (NA) -5.48  (6.91) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0) -7.80  (8.13) NA [1]   (NA) -9.03  (9.79) NA [1]   (NA) -8.74  (6.94) -8.06  (7.40) -9.31  (7.51) -8.26  (8.30) NA [1]   (NA) -7.15  (6.82) NA [1]   (NA)
Week 12 (n=64,0,59,0,64,66,66,70,0,61,0) -7.61  (9.15) NA [1]   (NA) -10.47  (9.71) NA [1]   (NA) -8.13  (8.00) -9.20  (7.16) -10.68  (7.37) -8.84  (8.48) NA [1]   (NA) -6.52  (8.28) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16) -10.67  (8.78) -5.95  (6.99) -13.00  (8.90) -2.46  (5.77) -10.60  (7.43) -9.95  (6.97) -10.66  (6.75) -10.65  (7.09) -5.83  (13.62) -8.65  (6.58) -6.88  (6.51)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17) -10.95  (8.32) -7.52  (8.20) -13.36  (8.25) -3.92  (5.72) -10.39  (6.98) -10.48  (7.21) -11.61  (6.35) -11.00  (6.99) -8.08  (9.89) -9.62  (7.31) -7.88  (9.21)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17) -12.15  (7.83) -6.60  (7.50) -13.00  (8.52) -5.46  (6.77) -10.25  (6.70) -10.48  (6.33) -11.70  (6.38) -11.57  (7.50) -9.08  (11.99) -10.28  (7.46) -7.35  (6.47)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
10.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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 67 13 71 74 75 80 12 69 17
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=70,0,66,0,71,74,75,80,0,69,0) 59.96  (25.67) NA [1]   (NA) 55.05  (24.81) NA [1]   (NA) 54.87  (26.68) 56.66  (25.42) 55.83  (22.85) 59.61  (23.61) NA [1]   (NA) 51.19  (27.72) NA [1]   (NA)
Week 2 (n=68,0,67,0,68,73,73,79,0,66,0) 49.53  (24.99) NA [1]   (NA) 43.33  (23.26) NA [1]   (NA) 44.35  (24.31) 41.26  (22.18) 37.82  (22.17) 40.57  (27.24) NA [1]   (NA) 46.91  (25.39) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0) 45.57  (24.99) NA [1]   (NA) 37.83  (22.77) NA [1]   (NA) 40.03  (24.25) 39.34  (25.09) 35.81  (23.88) 34.39  (24.29) NA [1]   (NA) 42.02  (24.40) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,61,0) 38.74  (24.31) NA [1]   (NA) 33.75  (25.06) NA [1]   (NA) 33.33  (24.18) 34.38  (23.15) 32.97  (23.50) 33.65  (25.47) NA [1]   (NA) 42.21  (27.12) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0) 38.97  (23.33) NA [1]   (NA) 28.81  (23.86) NA [1]   (NA) 36.55  (25.00) 34.60  (24.04) 30.26  (22.20) 31.16  (24.86) NA [1]   (NA) 41.34  (26.45) NA [1]   (NA)
Week 12 (n=64,0,59,0,64,65,66,70,0,61,0) 35.92  (22.49) NA [1]   (NA) 30.90  (24.44) NA [1]   (NA) 28.88  (22.80) 33.78  (25.50) 31.48  (24.86) 31.09  (26.57) NA [1]   (NA) 41.02  (26.13) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,54,12,37,16) 27.83  (18.65) 40.38  (21.81) 29.67  (24.13) 39.31  (24.13) 28.98  (22.15) 30.33  (22.04) 27.07  (20.76) 24.56  (23.46) 51.25  (21.95) 30.08  (22.81) 38.38  (24.52)
Week 20 (n=39,21,43,13,57,65,59,55,12,37,17) 29.28  (22.75) 35.71  (22.42) 26.63  (23.48) 42.31  (28.61) 25.91  (23.10) 33.66  (24.02) 24.69  (20.98) 24.58  (26.24) 43.92  (27.07) 25.08  (21.19) 33.00  (27.70)
Week 24 (n=40,20,44,13,55,63,60,53,12,36,17) 25.53  (21.05) 38.15  (26.27) 25.98  (20.61) 35.62  (28.27) 24.45  (20.24) 28.65  (21.11) 24.47  (22.23) 19.92  (18.27) 35.33  (27.17) 27.14  (21.17) 33.65  (26.15)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
11.Secondary Outcome
Title Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 68 21 65 13 68 73 73 79 12 66 17
Mean (Standard Deviation)
Unit of Measure: mm
Week 2 (n=65,0,68,0,68,73,73,79,0,66,0) -9.49  (24.31) NA [1]   (NA) -11.00  (20.82) NA [1]   (NA) -10.76  (26.22) -15.30  (25.46) -17.67  (24.58) -18.84  (25.59) NA [1]   (NA) -4.55  (25.28) NA [1]   (NA)
Week 4 (n=68,0,63,0,67,70,72,76,0,66,0) -13.44  (26.39) NA [1]   (NA) -17.11  (23.98) NA [1]   (NA) -14.76  (24.06) -17.80  (30.25) -20.39  (28.95) -24.74  (26.39) NA [1]   (NA) -9.26  (28.24) NA [1]   (NA)
Week 6 (n=66,0,63,0,69,71,72,74,0,61,0) -19.56  (31.29) NA [1]   (NA) -22.71  (28.84) NA [1]   (NA) -21.07  (29.07) -22.94  (29.71) -22.61  (28.87) -26.97  (26.15) NA [1]   (NA) -8.61  (29.03) NA [1]   (NA)
Week 8 (n=66,0,60,0,66,67,70,73,0,61,0) -19.91  (26.68) NA [1]   (NA) -26.23  (29.28) NA [1]   (NA) -18.11  (29.71) -21.84  (30.42) -24.66  (30.16) -29.08  (27.13) NA [1]   (NA) -9.97  (28.48) NA [1]   (NA)
Week 12 (n=64,0,57,0,64,65,66,70,0,61,0) -23.16  (28.49) NA [1]   (NA) -24.39  (30.89) NA [1]   (NA) -25.75  (29.47) -24.02  (27.96) -23.95  (29.90) -29.67  (28.25) NA [1]   (NA) -10.30  (30.14) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,54,12,37,16) -34.02  (31.75) -13.48  (25.66) -27.19  (24.93) -15.15  (21.97) -26.50  (28.81) -26.64  (25.04) -27.97  (29.32) -32.09  (24.84) -19.00  (29.73) -17.22  (35.13) -18.19  (21.36)
Week 20 (n=39,21,41,13,57,65,59,55,12,37,17) -31.54  (36.96) -18.14  (25.06) -32.37  (26.83) -12.15  (25.36) -29.54  (30.99) -22.78  (30.27) -30.97  (31.28) -32.95  (27.48) -26.33  (33.15) -22.22  (30.68) -21.82  (21.49)
Week 24 (n=40,20,42,13,55,63,60,53,12,36,17) -36.08  (32.62) -15.40  (24.78) -33.19  (25.68) -18.85  (24.73) -29.89  (30.87) -28.51  (28.01) -31.00  (31.88) -36.98  (27.86) -34.92  (31.74) -21.08  (32.99) -21.18  (26.30)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
12.Secondary Outcome
Title Patient Global Assessment (PtGA) of Arthritis
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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 79 12 69 17
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=70,0,68,0,71,74,75,79,0,69,0) 62.47  (24.77) NA [1]   (NA) 58.91  (22.94) NA [1]   (NA) 54.62  (23.71) 58.35  (23.14) 56.09  (21.42) 57.24  (25.64) NA [1]   (NA) 51.88  (26.44) NA [1]   (NA)
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0) 53.19  (22.93) NA [1]   (NA) 41.96  (23.12) NA [1]   (NA) 42.56  (22.89) 42.32  (21.98) 35.73  (21.46) 41.80  (26.25) NA [1]   (NA) 46.33  (25.02) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0) 47.87  (23.21) NA [1]   (NA) 39.78  (22.47) NA [1]   (NA) 38.94  (22.27) 38.53  (24.49) 34.76  (21.33) 37.47  (25.17) NA [1]   (NA) 41.21  (24.46) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,61,0) 42.30  (22.34) NA [1]   (NA) 36.08  (23.56) NA [1]   (NA) 33.01  (24.06) 35.41  (22.68) 30.56  (21.87) 34.86  (25.24) NA [1]   (NA) 43.02  (25.14) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0) 41.06  (21.76) NA [1]   (NA) 30.11  (22.38) NA [1]   (NA) 36.50  (25.29) 36.09  (24.38) 30.61  (21.60) 31.85  (25.35) NA [1]   (NA) 40.64  (25.32) NA [1]   (NA)
Week 12 (n=64,0,59,0,64,65,66,70,0,60,0) 38.78  (22.91) NA [1]   (NA) 34.42  (25.15) NA [1]   (NA) 29.66  (21.69) 35.05  (24.65) 32.53  (24.48) 30.76  (25.59) NA [1]   (NA) 39.85  (25.75) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,54,12,37,16) 30.76  (20.40) 38.29  (19.76) 29.84  (24.12) 39.31  (27.48) 30.62  (22.56) 30.98  (22.06) 26.59  (20.19) 24.76  (22.53) 50.67  (23.10) 28.46  (22.69) 37.63  (23.11)
Week 20 (n=39,21,43,13,57,66,59,55,12,37,17) 29.85  (22.86) 37.95  (23.62) 28.16  (22.36) 42.08  (27.48) 26.07  (22.75) 35.00  (23.51) 24.90  (20.57) 25.56  (23.20) 44.42  (27.38) 26.22  (21.09) 36.94  (27.13)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17) 28.23  (21.42) 38.55  (27.08) 25.93  (22.22) 38.23  (27.28) 23.64  (21.82) 29.66  (21.58) 25.07  (23.20) 21.85  (18.07) 34.83  (27.04) 28.25  (21.49) 34.59  (27.87)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
13.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 68 21 68 13 68 73 73 78 12 66 17
Mean (Standard Deviation)
Unit of Measure: mm
Week 2 (n=68,0,68,0,68,73,73,78,0,66,0) -8.57  (26.12) NA [1]   (NA) -16.96  (20.11) NA [1]   (NA) -12.37  (21.83) -16.74  (24.15) -20.25  (26.92) -15.38  (30.86) NA [1]   (NA) -5.82  (24.96) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,75,0,66,0) -13.90  (25.53) NA [1]   (NA) -19.40  (25.40) NA [1]   (NA) -15.70  (22.92) -20.76  (26.76) -21.82  (28.55) -19.04  (29.28) NA [1]   (NA) -10.65  (27.81) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,73,0,61,0) -18.71  (29.02) NA [1]   (NA) -22.02  (25.83) NA [1]   (NA) -20.81  (24.06) -24.03  (23.89) -25.26  (30.85) -22.99  (29.63) NA [1]   (NA) -9.46  (23.90) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,72,0,61,0) -20.35  (27.84) NA [1]   (NA) -27.48  (26.13) NA [1]   (NA) -17.44  (28.12) -22.58  (25.37) -24.81  (31.07) -25.92  (30.55) NA [1]   (NA) -11.48  (25.89) NA [1]   (NA)
Week 12 (n=64,0,59,0,64,65,66,69,0,60,0) -22.78  (28.81) NA [1]   (NA) -23.95  (29.82) NA [1]   (NA) -24.30  (24.57) -24.77  (26.21) -23.08  (30.87) -28.09  (30.23) NA [1]   (NA) -12.75  (28.20) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,53,12,37,16) -33.60  (31.45) -15.86  (22.28) -28.00  (28.15) -22.00  (26.01) -24.05  (28.00) -27.97  (24.02) -28.90  (29.36) -29.68  (31.20) -13.67  (35.93) -20.97  (31.57) -14.81  (17.72)
Week 20 (n=39,21,43,13,57,66,59,54,12,36,17) -34.56  (31.99) -16.19  (24.18) -30.93  (25.67) -19.23  (28.78) -28.33  (26.93) -23.95  (27.82) -31.12  (32.09) -30.67  (31.38) -19.92  (34.52) -23.22  (27.31) -13.53  (22.22)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17) -36.68  (29.89) -15.30  (32.99) -32.11  (25.76) -23.08  (31.06) -29.84  (27.59) -28.61  (25.31) -30.83  (32.96) -33.04  (32.02) -29.50  (32.33) -21.92  (27.51) -15.88  (25.95)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
14.Secondary Outcome
Title Physician Global Assessment 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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 80 12 69 17
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=70,0,68,0,71,74,75,80,0,69,0) 62.66  (16.00) NA [1]   (NA) 57.50  (18.47) NA [1]   (NA) 56.51  (19.00) 60.77  (16.75) 60.51  (14.26) 58.75  (17.90) NA [1]   (NA) 58.30  (15.25) NA [1]   (NA)
Week 2 (n=67,0,68,0,68,73,73,79,0,66,0) 49.49  (21.64) NA [1]   (NA) 41.07  (19.88) NA [1]   (NA) 42.29  (20.12) 42.85  (19.42) 35.99  (15.97) 41.92  (22.30) NA [1]   (NA) 49.05  (18.00) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,75,0,66,0) 41.69  (21.31) NA [1]   (NA) 36.92  (21.20) NA [1]   (NA) 34.73  (17.40) 33.56  (19.77) 33.35  (19.24) 32.96  (22.38) NA [1]   (NA) 40.23  (19.43) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0) 37.38  (17.11) NA [1]   (NA) 31.51  (21.25) NA [1]   (NA) 27.78  (18.40) 30.82  (19.95) 27.08  (17.28) 32.65  (23.41) NA [1]   (NA) 37.85  (21.03) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0) 35.71  (21.03) NA [1]   (NA) 26.60  (20.34) NA [1]   (NA) 27.26  (19.97) 28.01  (19.90) 23.06  (17.18) 27.70  (21.09) NA [1]   (NA) 34.66  (21.39) NA [1]   (NA)
Week 12 (n=63,0,59,0,64,66,65,70,0,61,0) 33.65  (20.06) NA [1]   (NA) 26.17  (21.33) NA [1]   (NA) 24.77  (18.80) 26.47  (19.69) 23.28  (17.89) 28.93  (23.44) NA [1]   (NA) 35.70  (24.86) NA [1]   (NA)
Week 16 (n=42,21,44,13,58,66,61,55,12,37,16) 23.95  (16.25) 44.19  (24.68) 19.77  (19.74) 33.31  (22.97) 23.67  (21.04) 23.00  (18.60) 19.31  (15.80) 18.60  (15.00) 48.42  (30.00) 26.22  (18.43) 27.44  (16.36)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17) 20.44  (18.10) 34.29  (16.64) 20.91  (18.21) 32.92  (25.15) 20.65  (18.68) 24.05  (18.32) 16.19  (12.41) 18.84  (18.42) 44.67  (25.31) 21.95  (18.03) 33.94  (22.43)
Week 24 (n=40,19,43,13,55,64,60,53,11,36,17) 18.90  (16.51) 36.53  (21.17) 20.26  (18.12) 32.54  (24.26) 16.91  (14.67) 21.25  (17.79) 14.68  (13.07) 14.49  (11.75) 41.00  (31.58) 20.67  (15.81) 32.18  (19.03)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
15.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 67 21 68 13 68 73 73 79 12 68 17
Mean (Standard Deviation)
Unit of Measure: mm
Week 2 (n=67,0,68,0,68,73,73,79,0,66,0) -12.88  (17.84) NA [1]   (NA) -16.43  (19.20) NA [1]   (NA) -14.60  (24.01) -17.88  (17.66) -24.30  (18.32) -16.61  (19.17) NA [1]   (NA) -8.82  (13.20) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,75,0,66,0) -20.66  (19.47) NA [1]   (NA) -20.80  (22.47) NA [1]   (NA) -22.00  (20.79) -27.67  (20.61) -27.43  (21.04) -25.31  (22.01) NA [1]   (NA) -17.79  (18.95) NA [1]   (NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0) -25.02  (20.89) NA [1]   (NA) -26.34  (24.05) NA [1]   (NA) -28.80  (20.44) -30.39  (20.61) -33.26  (19.40) -25.93  (23.04) NA [1]   (NA) -20.15  (22.19) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0) -26.50  (22.83) NA [1]   (NA) -30.92  (22.85) NA [1]   (NA) -29.67  (24.30) -33.63  (21.96) -37.26  (19.37) -30.66  (21.10) NA [1]   (NA) -22.82  (22.89) NA [1]   (NA)
Week 12 (n=63,0,59,0,64,66,66,70,0,61,0) -28.76  (23.50) NA [1]   (NA) -31.69  (24.30) NA [1]   (NA) -31.58  (23.09) -34.98  (20.53) -36.80  (20.78) -30.27  (22.44) NA [1]   (NA) -21.77  (24.51) NA [1]   (NA)
Week 16 (n=42,21,44,13,58,66,61,55,12,37,16) -39.33  (19.85) -16.95  (26.42) -39.23  (23.11) -23.85  (19.42) -33.47  (26.06) -38.45  (20.53) -39.70  (20.34) -38.65  (17.68) -19.08  (29.20) -29.89  (22.16) -32.56  (15.65)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17) -42.21  (23.73) -26.86  (23.81) -38.70  (20.41) -24.23  (22.29) -36.81  (24.26) -37.41  (18.99) -43.42  (16.85) -38.16  (19.33) -22.83  (26.51) -34.16  (23.25) -26.29  (24.43)
Week 24 (n=40,19,43,13,55,64,60,53,11,36,17) -44.15  (22.39) -24.11  (24.91) -39.98  (21.13) -24.62  (19.99) -39.51  (22.83) -40.61  (20.10) -44.65  (16.76) -41.91  (17.09) -28.64  (31.29) -35.06  (21.26) -28.06  (20.84)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
16.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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 66 13 71 74 75 80 12 69 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=70,0,66,0,71,74,75,80,0,69,0) 1.58  (0.57) NA [1]   (NA) 1.36  (0.75) NA [1]   (NA) 1.44  (0.64) 1.33  (0.60) 1.41  (0.64) 1.46  (0.58) NA [1]   (NA) 1.20  (0.73) NA [1]   (NA)
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0) 1.41  (0.61) NA [1]   (NA) 1.14  (0.75) NA [1]   (NA) 1.20  (0.58) 1.16  (0.61) 1.15  (0.67) 1.23  (0.63) NA [1]   (NA) 1.15  (0.64) NA [1]   (NA)
Week 4 (n=68,0,65,0,67,70,72,75,0,66,0) 1.32  (0.61) NA [1]   (NA) 1.03  (0.69) NA [1]   (NA) 1.13  (0.65) 1.08  (0.64) 1.12  (0.69) 1.14  (0.65) NA [1]   (NA) 1.14  (0.66) NA [1]   (NA)
Week 6 (n=66,0,64,0,69,71,72,74,0,61,0) 1.23  (0.57) NA [1]   (NA) 0.96  (0.69) NA [1]   (NA) 1.03  (0.61) 1.02  (0.65) 1.05  (0.69) 1.05  (0.65) NA [1]   (NA) 1.07  (0.70) NA [1]   (NA)
Week 8 (n=66,0,62,0,66,67,70,71,0,61,0) 1.22  (0.59) NA [1]   (NA) 0.93  (0.68) NA [1]   (NA) 1.06  (0.66) 0.89  (0.67) 0.98  (0.68) 0.98  (0.72) NA [1]   (NA) 1.05  (0.71) NA [1]   (NA)
Week 12 (n=64,0,59,0,64,65,66,68,0,61,0) 1.19  (0.63) NA [1]   (NA) 0.92  (0.75) NA [1]   (NA) 0.94  (0.65) 0.95  (0.68) 0.96  (0.69) 0.90  (0.67) NA [1]   (NA) 1.08  (0.74) NA [1]   (NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16) 1.05  (0.59) 1.42  (0.64) 0.82  (0.72) 1.18  (0.77) 0.92  (0.60) 0.91  (0.68) 0.97  (0.75) 0.81  (0.67) 1.36  (0.67) 0.80  (0.64) 1.05  (0.80)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17) 0.95  (0.58) 1.33  (0.72) 0.77  (0.68) 1.13  (0.78) 0.78  (0.57) 0.84  (0.65) 0.92  (0.72) 0.75  (0.63) 1.42  (0.62) 0.73  (0.65) 0.92  (0.75)
Week 24 (n=40,20,44,13,54,63,59,53,12,36,17) 0.99  (0.57) 1.38  (0.74) 0.85  (0.68) 1.05  (0.84) 0.78  (0.62) 0.85  (0.66) 0.88  (0.69) 0.72  (0.61) 1.34  (0.78) 0.74  (0.66) 0.95  (0.68)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
17.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 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. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 68 21 66 13 68 73 73 79 12 66 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0) -0.15  (0.38) NA [1]   (NA) -0.23  (0.49) NA [1]   (NA) -0.23  (0.41) -0.18  (0.42) -0.24  (0.40) -0.23  (0.45) NA [1]   (NA) -0.05  (0.36) NA [1]   (NA)
Week 4 (n=68,0,63,0,67,70,72,75,0,66,0) -0.24  (0.46) NA [1]   (NA) -0.36  (0.52) NA [1]   (NA) -0.32  (0.51) -0.25  (0.45) -0.31  (0.44) -0.34  (0.50) NA [1]   (NA) -0.05  (0.46) NA [1]   (NA)
Week 6 (n=66,0,62,0,69,71,72,74,0,61,0) -0.31  (0.45) NA [1]   (NA) -0.39  (0.53) NA [1]   (NA) -0.42  (0.54) -0.32  (0.57) -0.34  (0.47) -0.42  (0.52) NA [1]   (NA) -0.13  (0.59) NA [1]   (NA)
Week 8 (n=66,0,61,0,66,67,70,71,0,61,0) -0.34  (0.48) NA [1]   (NA) -0.41  (0.63) NA [1]   (NA) -0.40  (0.58) -0.43  (0.66) -0.39  (0.49) -0.50  (0.61) NA [1]   (NA) -0.12  (0.55) NA [1]   (NA)
Week 12 (n=64,0,58,0,64,65,66,68,0,61,0) -0.37  (0.48) NA [1]   (NA) -0.48  (0.61) NA [1]   (NA) -0.51  (0.61) -0.37  (0.63) -0.45  (0.50) -0.58  (0.61) NA [1]   (NA) -0.10  (0.57) NA [1]   (NA)
Week 16 (n=42,21,44,13,58,66,61,55,12,37,16) -0.52  (0.48) -0.16  (0.50) -0.59  (0.64) -0.08  (0.31) -0.52  (0.59) -0.41  (0.63) -0.45  (0.60) -0.62  (0.62) -0.46  (0.58) -0.30  (0.52) -0.01  (0.29)
Week 20 (n=39,21,43,13,57,66,59,55,12,37,17) -0.62  (0.47) -0.24  (0.42) -0.62  (0.68) -0.13  (0.41) -0.64  (0.62) -0.49  (0.58) -0.51  (0.59) -0.67  (0.65) -0.41  (0.55) -0.38  (0.54) -0.11  (0.30)
Week 24 (n=40,20,42,13,54,63,59,53,12,36,17) -0.60  (0.52) -0.21  (0.58) -0.53  (0.65) -0.21  (0.32) -0.61  (0.65) -0.47  (0.62) -0.53  (0.60) -0.66  (0.72) -0.48  (0.74) -0.37  (0.54) -0.08  (0.29)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
18.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 deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 80 12 69 17
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=70,0,68,0,71,74,75,80,0,69,0) 16.30  (18.08) NA [1]   (NA) 15.85  (19.34) NA [1]   (NA) 18.03  (24.96) 14.42  (17.81) 17.21  (16.94) 14.68  (17.19) NA [1]   (NA) 18.88  (19.55) NA [1]   (NA)
Week 2 (n=65,0,63,0,63,69,68,74,0,61,0) 14.54  (19.53) NA [1]   (NA) 8.20  (11.77) NA [1]   (NA) 6.98  (10.05) 5.24  (9.59) 4.08  (4.79) 8.35  (13.48) NA [1]   (NA) 18.10  (20.41) NA [1]   (NA)
Week 4 (n=65,0,61,0,62,64,65,70,0,61,0) 10.28  (11.83) NA [1]   (NA) 10.11  (15.29) NA [1]   (NA) 8.63  (12.54) 5.46  (9.76) 4.63  (8.68) 8.67  (13.62) NA [1]   (NA) 15.30  (16.85) NA [1]   (NA)
Week 6 (n=64,0,61,0,66,67,66,69,0,58,0) 10.55  (9.79) NA [1]   (NA) 8.34  (13.70) NA [1]   (NA) 8.26  (14.30) 5.42  (10.04) 5.41  (8.63) 10.68  (17.49) NA [1]   (NA) 15.18  (19.32) NA [1]   (NA)
Week 8 (n=63,0,59,0,62,62,67,67,0,58,0) 9.62  (11.78) NA [1]   (NA) 7.64  (11.54) NA [1]   (NA) 7.17  (11.47) 10.18  (24.04) 8.39  (11.39) 9.75  (18.92) NA [1]   (NA) 20.38  (30.37) NA [1]   (NA)
Week 12 (n=61,0,57,0,60,63,62,65,0,60,0) 8.53  (9.59) NA [1]   (NA) 9.54  (13.52) NA [1]   (NA) 6.54  (9.68) 9.11  (20.08) 5.81  (7.25) 9.53  (15.08) NA [1]   (NA) 19.69  (20.07) NA [1]   (NA)
Week 16 (n=42,21,43,13,54,64,58,55,9,37,16) 7.80  (10.30) 7.02  (8.51) 10.72  (18.93) 5.85  (5.47) 5.40  (8.06) 6.77  (10.27) 9.79  (22.24) 6.52  (11.33) 6.89  (7.06) 13.08  (11.49) 6.52  (7.30)
Week 20 (n=39,21,44,13,57,63,57,55,12,36,17) 8.96  (11.64) 8.55  (12.87) 7.71  (10.88) 11.28  (17.83) 7.93  (19.22) 5.58  (8.69) 3.46  (3.17) 4.75  (5.28) 7.89  (9.08) 16.14  (16.63) 12.10  (18.21)
Week 24 (n=39,20,43,13,53,63,56,52,12,36,17) 7.63  (10.26) 6.02  (7.31) 10.31  (17.43) 12.58  (12.19) 5.92  (14.78) 6.66  (17.03) 6.51  (11.04) 4.54  (4.69) 7.19  (8.18) 13.39  (15.05) 16.21  (26.51)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
19.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 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 ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 65 21 63 13 63 69 68 74 12 61 17
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 2 (n=65,0,63,0,63,69,68,74,0,61,0) -2.05  (18.32) NA [1]   (NA) -6.93  (14.85) NA [1]   (NA) -11.38  (19.27) -9.19  (19.90) -11.87  (15.22) -6.56  (12.70) NA [1]   (NA) 0.64  (14.26) NA [1]   (NA)
Week 4 (n=65,0,61,0,62,64,65,70,0,61,0) -6.07  (14.44) NA [1]   (NA) -5.12  (17.24) NA [1]   (NA) -8.54  (16.65) -9.45  (16.27) -11.70  (17.89) -6.69  (13.99) NA [1]   (NA) -1.26  (12.51) NA [1]   (NA)
Week 6 (n=64,0,61,0,66,67,66,69,0,58,0) -5.92  (16.61) NA [1]   (NA) -6.97  (17.77) NA [1]   (NA) -9.81  (23.67) -9.38  (16.02) -10.73  (17.63) -5.03  (17.94) NA [1]   (NA) -0.51  (12.72) NA [1]   (NA)
Week 8 (n=63,0,59,0,62,62,67,67,0,58,0) -5.94  (16.03) NA [1]   (NA) -7.42  (14.21) NA [1]   (NA) -11.35  (21.25) -4.97  (24.54) -8.67  (18.05) -6.11  (19.97) NA [1]   (NA) 3.70  (25.55) NA [1]   (NA)
Week 12 (n=61,0,57,0,60,63,62,65,0,60,0) -7.56  (17.07) NA [1]   (NA) -6.28  (14.07) NA [1]   (NA) -12.52  (23.93) -5.96  (23.26) -10.18  (16.26) -5.71  (20.18) NA [1]   (NA) 2.07  (15.90) NA [1]   (NA)
Week 16 (n=42,21,43,13,54,64,58,55,9,37,16) -6.96  (10.61) -11.26  (21.64) -7.04  (21.18) -6.33  (10.48) -11.53  (22.00) -8.18  (18.99) -7.01  (27.54) -8.16  (17.01) -7.59  (12.45) -2.59  (13.79) -13.44  (12.75)
Week 20 (n=39,21,44,13,57,63,57,55,12,36,17) -6.21  (10.94) -9.73  (22.12) -11.31  (16.46) -0.90  (20.08) -7.80  (23.28) -9.60  (19.16) -14.21  (16.73) -9.65  (15.32) -10.22  (13.83) 0.11  (15.15) -7.52  (20.34)
Week 24 (n=39,20,43,43,53,63,56,52,12,36,17) -7.61  (11.78) -8.07  (10.28) -7.57  (22.26) 0.40  (16.50) -8.18  (19.26) -8.72  (22.73) -10.65  (18.76) -8.75  (15.40) -10.92  (15.78) -2.16  (16.06) -3.41  (26.61)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
20.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 more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.
Time Frame Baseline, Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 21 68 13 71 74 75 80 12 69 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=70,0,68,0,71,74,75,79,0,69,0) 5.48  (0.80) NA [1]   (NA) 5.31  (0.95) NA [1]   (NA) 5.14  (0.84) 5.28  (0.85) 5.39  (0.89) 5.34  (0.87) NA [1]   (NA) 5.26  (0.96) NA [1]   (NA)
Week 2 (n=64,0,63,0,63,69,68,74,0,61,0) 4.88  (1.04) NA [1]   (NA) 4.46  (1.03) NA [1]   (NA) 4.26  (0.90) 4.18  (1.04) 4.18  (1.16) 4.28  (1.07) NA [1]   (NA) 4.91  (1.07) NA [1]   (NA)
Week 4 (n=65,0,61,0,62,64,65,70,0,61,0) 4.45  (1.08) NA [1]   (NA) 4.03  (1.17) NA [1]   (NA) 4.03  (0.96) 3.66  (1.12) 3.75  (1.13) 3.99  (1.11) NA [1]   (NA) 4.60  (1.01) NA [1]   (NA)
Week 6 (n=63,0,61,0,66,67,66,69,0,58,0) 4.32  (1.12) NA [1]   (NA) 3.74  (1.30) NA [1]   (NA) 3.68  (1.00) 3.59  (1.27) 3.60  (1.13) 3.94  (1.16) NA [1]   (NA) 4.35  (1.04) NA [1]   (NA)
Week 8 (n=63,0,59,0,62,62,67,67,0,58,0) 4.21  (1.22) NA [1]   (NA) 3.63  (1.27) NA [1]   (NA) 3.54  (1.01) 3.61  (1.23) 3.38  (1.10) 3.72  (1.35) NA [1]   (NA) 4.30  (1.08) NA [1]   (NA)
Week 12 (n=61,0,55,0,60,63,62,65,0,60,0) 3.98  (1.15) NA [1]   (NA) 3.46  (1.38) NA [1]   (NA) 3.57  (1.09) 3.40  (1.27) 3.28  (1.25) 3.61  (1.25) NA [1]   (NA) 4.37  (1.29) NA [1]   (NA)
Week 16 (n=42,21,43,13,54,64,58,55,9,37,16) 3.59  (1.15) 4.33  (1.16) 3.11  (1.23) 4.19  (1.48) 3.19  (1.10) 3.34  (1.22) 3.12  (1.25) 3.14  (1.06) 4.65  (1.08) 3.93  (1.06) 3.91  (1.19)
Week 20 (n=39,21,44,13,57,63,57,55,12,36,17) 3.48  (1.28) 3.83  (1.62) 3.06  (1.25) 4.24  (1.56) 3.09  (1.17) 3.14  (1.29) 2.94  (1.04) 3.08  (1.11) 4.82  (1.24) 3.81  (1.23) 3.86  (1.24)
Week 24 (n=39,20,42,13,53,63,56,52,12,36,17) 3.39  (1.15) 3.88  (1.49) 3.14  (1.26) 4.08  (1.35) 3.03  (1.05) 3.15  (1.19) 2.91  (1.12) 3.07  (0.98) 4.51  (1.61) 3.48  (1.06) 4.08  (1.37)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
21.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, 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 DAS28-3 (CRP) <2.6 = remission.
Time Frame Baseline, Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 64 21 63 13 63 69 68 73 12 61 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 (n=64,0,63,0,63,69,68,73,0,61,0) -0.55  (0.76) NA [1]   (NA) -0.78  (0.92) NA [1]   (NA) -0.86  (0.82) -1.07  (0.84) -1.22  (1.08) -1.01  (0.97) NA [1]   (NA) -0.26  (0.78) NA [1]   (NA)
Week 4 (n=65,0,61,0,62,64,65,69,0,61,0) -0.99  (0.91) NA [1]   (NA) -1.23  (1.19) NA [1]   (NA) -1.09  (0.94) -1.58  (1.09) -1.71  (1.20) -1.30  (1.06) NA [1]   (NA) -0.57  (0.88) NA [1]   (NA)
Week 6 (n=63,0,61,0,66,67,66,69,0,58,0) -1.13  (1.03) NA [1]   (NA) -1.52  (1.27) NA [1]   (NA) -1.44  (0.99) -1.66  (1.18) -1.81  (1.17) -1.38  (1.07) NA [1]   (NA) -0.80  (0.93) NA [1]   (NA)
Week 8 (n=63,0,59,0,62,62,67,67,0,58,0) -1.22  (1.14) NA [1]   (NA) -1.61  (1.18) NA [1]   (NA) -1.56  (0.97) -1.63  (1.25) -2.02  (1.14) -1.63  (1.17) NA [1]   (NA) -0.83  (1.11) NA [1]   (NA)
Week 12 (n=61,0,55,0,60,63,62,65,0,60,0) -1.45  (1.13) NA [1]   (NA) -1.85  (1.27) NA [1]   (NA) -1.59  (1.18) -1.82  (1.17) -2.13  (1.32) -1.72  (1.13) NA [1]   (NA) -0.82  (1.11) NA [1]   (NA)
Week 16 (n=42,21,43,13,54,64,58,55,9,37,16) -1.87  (1.13) -1.14  (0.99) -2.27  (1.14) -0.81  (1.20) -1.93  (1.12) -1.89  (1.13) -2.31  (1.39) -2.13  (1.04) -0.88  (0.95) -1.14  (1.03) -1.43  (0.70)
Week 20 (n=39,21,44,13,57,63,57,55,12,36,17) -1.94  (1.26) -1.64  (1.25) -2.41  (1.26) -0.76  (1.22) -2.05  (1.15) -2.09  (1.28) -2.49  (1.26) -2.17  (0.96) -0.95  (0.81) -1.27  (1.37) -1.47  (1.04)
Week 24 (n=39,20,42,13,53,63,56,52,12,36,17) -2.06  (1.22) -1.55  (1.07) -2.29  (1.19) -0.92  (1.17) -2.06  (1.04) -2.13  (1.12) -2.49  (1.27) -2.19  (1.04) -1.26  (1.23) -1.55  (1.25) -1.25  (0.96)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
22.Secondary Outcome
Title Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)
Hide Description Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) 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, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 64 21 63 13 63 69 68 74 12 61 17
Measure Type: Number
Unit of Measure: percentage of participants
Week 2: Good (n=64,0,63,0,63,69,68,74,0,61,0) 4.7 NA [1]  4.8 NA [1]  9.5 13.0 16.2 12.2 NA [1]  3.3 NA [1] 
Week 2: Mod (n=64,0,63,0,63,69,68,74,0,61,0) 23.4 NA [1]  44.4 NA [1]  42.9 46.4 50.0 41.9 NA [1]  23.0 NA [1] 
Week 2: None (n=64,0,63,0,63,69,68,74,0,61,0) 71.9 NA [1]  50.8 NA [1]  47.6 40.6 33.8 44.6 NA [1]  73.8 NA [1] 
Week 4: Good (n=65,0,61,0,62,64,65,70,0,61,0) 10.8 NA [1]  21.3 NA [1]  16.1 28.1 30.8 21.4 NA [1]  8.2 NA [1] 
Week 4: Mod (n=65,0,61,0,62,64,65,70,0,61,0) 41.5 NA [1]  45.9 NA [1]  48.4 53.1 49.2 42.9 NA [1]  34.4 NA [1] 
Week 4: None (n=65,0,61,0,62,64,65,70,0,61,0) 47.7 NA [1]  32.8 NA [1]  35.5 18.8 20.0 34.3 NA [1]  57.4 NA [1] 
Week 6: Good (n=63,0,61,0,66,67,66,69,0,58,0) 11.1 NA [1]  29.5 NA [1]  31.8 29.9 31.8 23.2 NA [1]  12.1 NA [1] 
Week 6: Mod (n=63,0,61,0,66,67,66,69,0,58,0) 50.8 NA [1]  42.6 NA [1]  42.4 50.7 50.0 44.9 NA [1]  43.1 NA [1] 
Week 6: None (n=63,0,61,0,66,67,66,69,0,58,0) 38.1 NA [1]  27.9 NA [1]  25.8 19.4 18.2 31.9 NA [1]  44.8 NA [1] 
Week 8: Good (n=63,0,59,0,62,62,67,67,0,58,0) 19.0 NA [1]  30.5 NA [1]  37.1 32.3 43.3 37.3 NA [1]  13.8 NA [1] 
Week 8: Mod (n=63,0,59,0,62,62,67,67,0,58,0) 46.0 NA [1]  47.5 NA [1]  46.8 45.2 47.8 40.3 NA [1]  46.6 NA [1] 
Week 8: None (n=63,0,59,0,62,62,67,67,0,58,0) 34.9 NA [1]  22.0 NA [1]  16.1 22.6 9.0 22.4 NA [1]  39.7 NA [1] 
Week 12: Good (n=61,0,55,0,60,63,62,65,0,60,0) 23.0 NA [1]  45.5 NA [1]  33.3 41.3 51.6 36.9 NA [1]  16.7 NA [1] 
Week 12: Mod (n=61,0,55,0,60,63,62,65,0,60,0) 49.2 NA [1]  32.7 NA [1]  50.0 39.7 37.1 44.6 NA [1]  36.7 NA [1] 
Week 12: None (n=61,0,55,0,60,63,62,65,0,60,0) 27.9 NA [1]  21.8 NA [1]  16.7 19.0 11.3 18.5 NA [1]  46.7 NA [1] 
Week 16: Good (n=42,21,43,13,54,64,58,55,9,37,16) 40.5 19.0 55.8 30.8 51.9 50.0 48.3 52.7 11.1 27.0 18.8
Week 16: Mod (n=42,21,43,13,54,64,58,55,9,37,16) 50.0 38.1 32.6 23.1 37.0 34.4 43.1 43.6 33.3 40.5 62.5
Week 16: None (n=42,21,43,13,54,64,58,55,9,37,16) 9.5 42.9 11.6 46.2 11.1 15.6 8.6 3.6 55.6 32.4 18.8
Week 20: Good (n=39,21,44,13,57,63,57,55,12,36,17) 46.2 42.9 59.1 15.4 61.4 52.4 57.9 52.7 0.0 30.6 29.4
Week 20: Mod (n=39,21,44,13,57,63,57,55,12,36,17) 43.6 28.6 31.8 46.2 28.1 36.5 35.1 40.0 58.3 36.1 47.1
Week 20: None (n=39,21,44,13,57,63,57,55,12,36,17) 10.3 28.6 9.1 38.5 10.5 11.1 7.0 7.3 41.7 33.3 23.5
Week 24: Good (n=39,20,42,13,53,63,56,52,12,36,17) 43.6 35.0 54.8 23.1 52.8 58.7 66.1 59.6 25.0 33.3 23.5
Week 24: Mod (n=39,20,42,13,53,63,56,52,12,36,17) 46.2 35.0 33.3 38.5 37.7 30.2 23.2 34.6 33.3 41.7 47.1
Week 24: None (n=39,20,42,13,53,63,56,52,12,36,17) 10.3 30.0 11.9 38.5 9.4 11.1 10.7 5.8 41.7 25.0 29.4
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
23.Secondary Outcome
Title Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)
Hide Description DAS28-3 (CRP) defined remission was classified as a score of <2.6.
Time Frame Week 2, 4, 6, 8, 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 treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 64 21 63 13 63 68 68 74 12 61 17
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=64,0,63,0,63,68,68,74,0,61,0) 1.56 NA [1]  3.17 NA [1]  1.59 4.41 13.24 4.05 NA [1]  3.28 NA [1] 
Week 4 (n=65,0,61,0,62,63,65,70,0,61,0) 4.62 NA [1]  14.75 NA [1]  8.06 19.05 16.92 10.00 NA [1]  3.28 NA [1] 
Week 6 (n=63,0,61,0,66,66,66,69,0,58,0) 3.17 NA [1]  19.67 NA [1]  13.64 24.24 22.73 10.14 NA [1]  3.45 NA [1] 
Week 8 (n=63,0,59,0,62,61,67,67,0,58,0) 7.94 NA [1]  22.03 NA [1]  19.35 21.31 23.88 20.90 NA [1]  6.90 NA [1] 
Week 12 (n=61,0,55,0,60,62,62,65,0,60,0) 6.56 NA [1]  30.91 NA [1]  16.67 32.26 37.10 24.62 NA [1]  6.67 NA [1] 
Week 16 (n=42,21,43,13,54,63,58,55,9,37,16) 14.3 9.5 41.9 23.1 24.1 30.2 37.9 29.1 11.1 8.1 12.5
Week 20 (n=39,21,44,13,57,62,57,55,12,36,17) 20.5 28.6 43.2 15.4 35.1 37.1 38.6 30.9 0.0 13.9 17.6
Week 24 (n=39,20,42,13,53,63,56,52,12,36,17) 23.1 25.0 35.7 15.4 41.5 36.5 39.3 32.7 16.7 19.4 17.6
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
24.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36)
Hide Description SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame Baseline, Week 12, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 70 20 68 13 71 73 75 80 12 69 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Ph Fn (n=70,0,68,0,71,73,75,80,0,69,0) 31.48  (10.33) NA [1]   (NA) 33.20  (11.04) NA [1]   (NA) 31.93  (9.66) 31.92  (9.15) 31.50  (9.29) 30.23  (9.70) NA [1]   (NA) 34.01  (11.06) NA [1]   (NA)
Baseline: R-P (n=70,0,68,0,71,73,75,80,0,69,0) 34.53  (8.52) NA [1]   (NA) 34.45  (10.52) NA [1]   (NA) 35.54  (8.69) 34.64  (10.72) 33.70  (9.85) 33.13  (9.32) NA [1]   (NA) 37.23  (9.51) NA [1]   (NA)
Baseline: BP (n=70,0,68,0,71,73,75,80,0,69,0) 34.14  (6.60) NA [1]   (NA) 34.60  (8.35) NA [1]   (NA) 35.36  (8.23) 35.11  (7.85) 34.98  (8.19) 34.20  (8.18) NA [1]   (NA) 35.93  (8.71) NA [1]   (NA)
Baseline: GH (n=70,0,68,0,71,73,75,80,0,69,0) 35.08  (6.77) NA [1]   (NA) 35.17  (8.02) NA [1]   (NA) 35.12  (8.90) 36.52  (9.28) 35.94  (8.44) 36.08  (8.48) NA [1]   (NA) 36.50  (9.38) NA [1]   (NA)
Baseline: Vit (n=70,0,68,0,71,73,75,80,0,69,0) 40.32  (9.95) NA [1]   (NA) 42.36  (10.07) NA [1]   (NA) 41.54  (9.39) 42.60  (10.83) 40.81  (11.75) 40.97  (9.98) NA [1]   (NA) 44.08  (11.63) NA [1]   (NA)
Baseline: So Fn (n=70,0,68,0,71,73,75,80,0,69,0) 37.76  (10.41) NA [1]   (NA) 38.88  (11.35) NA [1]   (NA) 37.72  (10.38) 38.99  (10.80) 38.01  (11.06) 38.03  (10.70) NA [1]   (NA) 40.09  (11.08) NA [1]   (NA)
Baseline: R-E (n=70,0,68,0,71,73,75,80,0,69,0) 34.72  (11.55) NA [1]   (NA) 35.18  (14.16) NA [1]   (NA) 37.21  (12.51) 36.23  (12.64) 34.73  (14.42) 35.13  (13.45) NA [1]   (NA) 39.37  (13.94) NA [1]   (NA)
Baseline: MnH (n=70,0,68,0,71,73,75,80,0,69,0) 38.98  (11.58) NA [1]   (NA) 40.07  (11.65) NA [1]   (NA) 41.88  (12.02) 42.79  (10.99) 39.68  (12.65) 39.91  (12.53) NA [1]   (NA) 42.91  (13.08) NA [1]   (NA)
Baseline: Ph C (n=70,0,68,0,71,73,75,80,0,69,0) 33.13  (6.72) NA [1]   (NA) 33.73  (8.33) NA [1]   (NA) 32.99  (8.03) 32.96  (8.15) 33.19  (7.31) 32.11  (8.57) NA [1]   (NA) 34.41  (8.59) NA [1]   (NA)
Baseline: Mn C (n=70,0,68,0,71,73,75,80,0,69,0) 40.39  (11.42) NA [1]   (NA) 41.47  (12.68) NA [1]   (NA) 42.81  (11.80) 43.53  (11.00) 40.92  (13.00) 41.68  (12.17) NA [1]   (NA) 44.72  (13.24) NA [1]   (NA)
Week 12: Ph Fn (n=63,0,59,0,64,65,65,70,0,61,0) 35.05  (10.73) NA [1]   (NA) 36.49  (11.63) NA [1]   (NA) 36.45  (9.78) 36.25  (10.75) 37.80  (10.76) 37.49  (11.48) NA [1]   (NA) 36.23  (11.37) NA [1]   (NA)
Week 12: R-P (n=63,0,59,0,64,65,65,70,0,61,0) 38.47  (8.77) NA [1]   (NA) 39.25  (10.85) NA [1]   (NA) 38.26  (10.21) 39.71  (9.69) 39.41  (10.03) 40.17  (10.41) NA [1]   (NA) 39.79  (10.14) NA [1]   (NA)
Week 12: BP (n=63,0,59,0,64,65,65,70,0,61,0) 41.62  (8.02) NA [1]   (NA) 42.76  (11.30) NA [1]   (NA) 42.73  (9.57) 44.00  (10.81) 44.39  (9.40) 44.21  (9.78) NA [1]   (NA) 39.46  (10.15) NA [1]   (NA)
Week 12: GH (n=63,0,59,0,64,65,65,70,0,61,0) 37.85  (8.10) NA [1]   (NA) 39.04  (8.74) NA [1]   (NA) 40.11  (9.54) 39.15  (8.76) 40.05  (9.44) 41.10  (9.78) NA [1]   (NA) 39.54  (10.42) NA [1]   (NA)
Week 12: Vit (n=63,0,59,0,64,65,65,70,0,61,0) 45.45  (9.82) NA [1]   (NA) 46.80  (10.08) NA [1]   (NA) 46.33  (10.59) 45.99  (10.68) 47.82  (10.24) 46.03  (11.42) NA [1]   (NA) 46.48  (12.24) NA [1]   (NA)
Week 12: So Fn (n=63,0,59,0,64,65,65,70,0,61,0) 41.18  (11.32) NA [1]   (NA) 43.54  (11.20) NA [1]   (NA) 42.28  (10.82) 42.84  (10.06) 43.93  (9.81) 44.23  (10.53) NA [1]   (NA) 41.38  (10.87) NA [1]   (NA)
Week 12: R-E (n=63,0,59,0,64,65,65,70,0,61,0) 39.47  (12.12) NA [1]   (NA) 39.14  (12.47) NA [1]   (NA) 39.90  (12.87) 39.01  (12.07) 39.07  (11.96) 41.33  (13.30) NA [1]   (NA) 40.39  (12.49) NA [1]   (NA)
Week 12: MnH (n=63,0,59,0,64,65,65,70,0,61,0) 43.84  (10.95) NA [1]   (NA) 44.57  (10.95) NA [1]   (NA) 45.34  (13.08) 43.08  (9.84) 45.24  (10.70) 46.11  (11.49) NA [1]   (NA) 43.36  (12.67) NA [1]   (NA)
Week 12: Ph C (n=63,0,59,0,64,65,65,70,0,61,0) 37.24  (8.19) NA [1]   (NA) 38.70  (9.73) NA [1]   (NA) 38.27  (9.31) 39.52  (9.30) 39.97  (8.98) 39.64  (10.20) NA [1]   (NA) 37.89  (9.94) NA [1]   (NA)
Week 12: Mn C (n=63,0,59,0,64,65,65,70,0,61,0) 44.86  (11.45) NA [1]   (NA) 45.47  (11.10) NA [1]   (NA) 45.84  (13.41) 44.18  (10.26) 45.61  (10.59) 46.65  (11.64) NA [1]   (NA) 45.08  (12.48) NA [1]   (NA)
Week 24: Ph Fn(n=40,20,44,13,55,64,60,53,12,36,17) 37.41  (10.35) 34.30  (10.72) 38.38  (11.35) 39.39  (11.83) 40.04  (10.81) 38.19  (10.88) 38.62  (11.08) 40.51  (12.11) 32.31  (11.36) 39.44  (10.64) 38.09  (10.04)
Week 24: R-P (n=40,20,44,13,55,64,60,53,12,36,17) 40.51  (8.53) 35.06  (9.36) 39.88  (11.85) 38.96  (10.26) 41.09  (9.12) 40.32  (10.91) 40.69  (9.67) 41.97  (10.80) 35.02  (10.72) 44.27  (9.80) 42.45  (9.44)
Week 24: BP (n=40,20,44,13,55,64,60,53,12,36,17) 44.17  (8.68) 39.57  (11.54) 44.15  (10.31) 43.07  (9.91) 44.96  (9.23) 44.52  (10.98) 45.76  (9.67) 46.89  (10.25) 40.32  (11.00) 43.11  (9.54) 44.24  (8.09)
Week 24: GH (n=40,20,44,13,55,64,60,53,12,36,17) 40.65  (7.40) 36.87  (7.75) 41.45  (10.05) 37.35  (5.95) 41.35  (10.23) 41.09  (9.27) 41.40  (9.24) 44.03  (9.52) 35.81  (11.52) 43.16  (9.70) 40.68  (8.34)
Week 24: Vit (n=40,20,44,13,55,64,60,53,12,36,17) 49.05  (10.69) 39.60  (9.23) 48.76  (11.25) 47.29  (6.58) 48.40  (10.41) 47.55  (10.18) 50.11  (11.68) 50.50  (10.98) 41.94  (13.65) 49.75  (11.83) 48.23  (11.92)
Week 24: So Fn(n=40,20,44,13,55,64,60,53,12,36,17) 43.62  (10.40) 39.40  (10.26) 42.84  (12.53) 43.84  (9.05) 45.25  (11.64) 43.56  (10.73) 44.67  (10.31) 46.35  (10.53) 38.67  (12.38) 45.18  (10.60) 43.05  (10.04)
Week 24: R-E (n=40,20,44,13,55,64,60,53,12,36,17) 40.23  (11.08) 34.30  (10.59) 40.59  (13.86) 37.94  (12.35) 41.46  (12.40) 40.15  (11.58) 40.39  (11.88) 42.31  (13.71) 37.09  (16.56) 42.27  (13.09) 46.28  (9.13)
Week 24: MnH (n=40,20,44,13,55,64,60,53,12,36,17) 45.92  (11.10) 38.74  (10.58) 45.66  (12.59) 44.59  (7.04) 47.29  (13.62) 43.89  (10.93) 46.86  (11.73) 47.24  (11.36) 43.44  (12.84) 45.63  (14.22) 47.52  (11.26)
Week 24: Ph C (n=40,20,44,13,55,64,60,53,12,36,17) 39.94  (8.41) 36.79  (9.76) 40.31  (9.95) 39.74  (9.76) 41.12  (9.22) 40.85  (9.79) 40.99  (9.14) 42.81  (10.22) 34.40  (10.57) 42.09  (9.20) 39.41  (9.58)
Week 24: Mn C(n=40,20,44,13,55,64,60,53,12,36,17) 46.62  (12.04) 39.10  (11.18) 46.21  (13.26) 44.52  (7.18) 47.34  (13.41) 45.03  (11.20) 47.21  (11.71) 48.03  (11.81) 43.35  (13.89) 47.08  (15.31) 49.27  (9.52)
[1]
Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
25.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET
Hide Description SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame Baseline, Week 12, 24/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies 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 CP-690,550 20 mg CP-690,550 20 mg 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 for 24 weeks. 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 for 24 weeks. 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 for 24 weeks.
CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. 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 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Matching placebo tablet orally twice daily for 24 weeks. 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 CP-690,550 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 63 20 59 13 64 64 65 70 12 61 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12: Ph Fn (n=63,0,59,0,64,64,65,70,0,61,0) 3.98  (7.08) NA [1]   (NA) 3.39  (9.60) NA [1]   (NA) 4.57  (8.25) 4.18  (11.13) 5.96  (8.21) 7.40  (9.15) NA [1]   (NA) 2.24  (8.79) NA [1]   (NA)
Week 12: R-P (n=63,0,59,0,64,64,65,70,0,61,0) 3.77  (8.00) NA [1]   (NA) 4.61  (11.45) NA [1]   (NA) 2.68  (9.44) 4.52  (11.62) 5.20  (9.27) 6.86  (9.69) NA [1]   (NA) 2.01  (9.91) NA [1]   (NA)
Week 12: BP (n=63,0,59,0,64,64,65,70,0,61,0) 7.29  (8.12) NA [1]   (NA) 8.80  (11.96) NA [1]   (NA) 7.28  (10.29) 8.74  (10.66) 9.23  (9.48) 10.54  (9.16) NA [1]   (NA) 3.23  (8.98) NA [1]   (NA)
Week 12: GH (n=63,0,59,0,64,64,65,70,0,61,0) 2.94  (7.04) NA [1]   (NA) 3.84  (7.61) NA [1]   (NA) 4.78  (8.81) 2.73  (7.46) 4.32  (8.59) 4.97  (9.64) NA [1]   (NA) 2.47  (10.32) NA [1]   (NA)
Week 12: Vit (n=63,0,59,0,64,64,65,70,0,61,0) 5.10  (8.99) NA [1]   (NA) 4.29  (9.92) NA [1]   (NA) 4.68  (9.86) 2.29  (8.80) 6.87  (8.76) 5.22  (8.28) NA [1]   (NA) 1.45  (11.66) NA [1]   (NA)
Week 12: So Fn (n=63,0,59,0,64,64,65,70,0,61,0) 3.72  (10.54) NA [1]   (NA) 4.99  (10.54) NA [1]   (NA) 4.26  (9.93) 3.49  (11.84) 4.70  (10.33) 5.84  (12.43) NA [1]   (NA) 0.80  (9.70) NA [1]   (NA)
Week 12: R-E (n=63,0,59,0,64,64,65,70,0,61,0) 4.26  (10.65) NA [1]   (NA) 3.69  (13.12) NA [1]   (NA) 2.25  (11.23) 2.73  (13.28) 3.77  (13.04) 5.33  (12.06) NA [1]   (NA) -0.96  (12.04) NA [1]   (NA)
Week 12: MnH (n=63,0,59,0,64,64,65,70,0,61,0) 4.92  (9.27) NA [1]   (NA) 4.63  (10.01) NA [1]   (NA) 3.43  (10.19) 0.04  (9.08) 4.68  (8.73) 5.59  (9.87) NA [1]   (NA) -0.88  (9.76) NA [1]   (NA)
Week 12: Ph C (n=63,0,59,0,64,64,65,70,0,61,0) 4.27  (6.38) NA [1]   (NA) 5.16  (8.82) NA [1]   (NA) 5.30  (8.03) 6.32  (8.72) 6.77  (7.29) 7.98  (7.95) NA [1]   (NA) 3.71  (7.43) NA [1]   (NA)
Week 12: Mn C (n=63,0,59,0,64,64,65,70,0,61,0) 4.30  (9.47) NA [1]   (NA) 3.94  (10.38) NA [1]   (NA) 2.72  (9.57) 0.28  (10.13) 3.81  (9.58) 4.18  (10.04) NA [1]   (NA) -1.40  (9.18) NA [1]   (NA)
Week 24: Ph Fn(n=40,20,44,13,55,63,60,53,12,36,17) 6.52  (8.32) 2.63  (9.94) 5.45  (8.57) 4.37  (8.35) 7.77  (9.41) 6.41  (11.62) 6.63  (10.30) 8.81  (10.48) 6.49  (8.15) 3.74  (9.56) 4.21  (9.84)
Week 24: R-P (n=40,20,44,13,55,63,60,53,12,36,17) 6.12  (8.34) 1.47  (7.72) 5.07  (11.00) 4.52  (6.77) 6.01  (10.23) 5.56  (9.76) 6.61  (9.33) 7.25  (11.27) 5.51  (10.50) 5.85  (11.43) 4.75  (8.64)
Week 24: BP (n=40,20,44,13,55,63,60,53,12,36,17) 10.65  (9.91) 3.85  (8.92) 10.16  (9.54) 9.75  (7.27) 10.09  (10.44) 9.21  (10.31) 10.44  (10.51) 11.86  (10.67) 10.67  (12.01) 5.92  (10.51) 7.73  (7.63)
Week 24: GH (n=40,20,44,13,55,63,60,53,12,36,17) 5.62  (7.70) 3.58  (6.97) 5.92  (7.09) 4.11  (9.07) 6.34  (7.85) 4.68  (8.77) 5.41  (7.88) 6.43  (8.93) 5.92  (9.84) 4.20  (12.05) 4.04  (3.82)
Week 24: Vit (n=40,20,44,13,55,63,60,53,12,36,17) 8.12  (9.94) 1.56  (10.79) 5.82  (9.30) 5.04  (10.16) 6.64  (9.03) 3.52  (9.27) 8.53  (9.99) 7.95  (11.17) 6.76  (11.52) 2.08  (13.86) 6.06  (6.19)
Week 24: So Fn(n=40,20,44,13,55,63,60,53,12,36,17) 5.86  (9.36) 3.27  (12.31) 4.09  (11.10) 5.87  (10.31) 7.54  (10.36) 4.16  (11.99) 4.91  (10.27) 6.79  (11.86) 3.64  (11.71) 3.33  (12.73) 3.85  (9.20)
Week 24: R-E (n=40,20,44,13,55,63,60,53,12,36,17) 4.28  (11.30) 2.33  (12.82) 5.48  (16.05) -0.30  (13.69) 4.24  (11.81) 4.01  (13.30) 5.18  (11.73) 5.57  (14.61) 2.27  (16.86) 0.97  (13.70) 2.29  (11.17)
Week 24: MnH (n=40,20,44,13,55,63,60,53,12,36,17) 7.25  (12.82) 1.83  (8.73) 4.99  (11.52) 4.98  (11.27) 5.43  (11.92) 0.36  (10.48) 5.44  (8.23) 5.31  (12.73) 6.57  (12.84) 0.70  (9.97)