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Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX (ORAL1069)

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ClinicalTrials.gov Identifier: NCT01039688
Recruitment Status : Completed
First Posted : December 25, 2009
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: CP-690,550
Drug: Disease-modifying antirheumatic drug
Enrollment 956
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 5 mg Twice Daily (BID) CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description Participants received CP-690,550 5 milligram (mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo methotrexate (MTX) capsules, orally, once per week, for up to 24 months. Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months. Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Period Title: Overall Study
Started 373 397 186
Completed 266 286 106
Not Completed 107 111 80
Reason Not Completed
Adverse Event             38             39             24
Lack of Efficacy             20             11             26
Lost to Follow-up             11             9             5
Not specified             13             25             12
Withdrawal by Subject             23             27             13
Death             2             0             0
Arm/Group Title CP-690,550 5 mg Twice Daily (BID) CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly Total
Hide Arm/Group Description Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months. Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months. Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance. Total of all reporting groups
Overall Number of Baseline Participants 373 397 186 956
Hide Baseline Analysis Population Description
All participants randomized to the study who received at least 1 dose of study drug (CP-690,550) or MTX.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 373 participants 397 participants 186 participants 956 participants
50.3  (12.2) 49.3  (12.8) 48.8  (13.3) 49.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 397 participants 186 participants 956 participants
Female
286
  76.7%
327
  82.4%
145
  78.0%
758
  79.3%
Male
87
  23.3%
70
  17.6%
41
  22.0%
198
  20.7%
1.Primary Outcome
Title Modified Total Sharp Score (mTSS) at Month 6
Hide Description mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690,550) or MTX (in MTX-naive participants) with a baseline (BL) and at least 1 nonmissing on-study assessment. Missing values due to withdrawal were imputed using linear extrapolation (LEP) of BL/post-BL value before withdrawal.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 346 369 166
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
20.50  (40.58) 18.85  (39.21) 17.54  (29.96)
2.Primary Outcome
Title Change From Baseline at Month 6 in mTSS
Hide Description mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, imputation using LEP
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 346 370 165
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.20  (0.09) 0.15  (0.08) 0.65  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg BID, MTX 10, 15, or 20 mg, Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.73 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg BID, MTX 10, 15, or 20 mg, Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.77 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6
Hide Description ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Missing values due to participant withdrawal were imputed using nonresponder imputation (NRI) method.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 366 391 182
Measure Type: Number
Unit of Measure: percentage of participants
25.41 37.34 12.09
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg BID, MTX 10, 15, or 20 mg, Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A stepdown procedure was used to control for multiple comparisons. For comparison of 5 mg to be statistically significant, comparison of 10 mg to MTX in ACR70 and comparison of 5 mg to MTX in change from BL in mTSS had to be statistically significant
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.32
Confidence Interval (2-Sided) 95%
6.81 to 19.82
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg BID, MTX 10, 15, or 20 mg, Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A stepdown procedure was used to control for multiple comparisons. For comparison of 10 mg to MTX in ACR70 to be statistically significant, comparison of 10 mg to MTX in change from BL in mTSS had to be statistically significant
Method Normal approximation
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 25.25
Confidence Interval (2-Sided) 95%
18.51 to 31.99
Estimation Comments [Not Specified]
4.Primary Outcome
Title Absolute Blood Pressure (BP) Values (mmHg)
Hide Description BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline: systolic BP Number Analyzed 373 participants 397 participants 186 participants
123.37  (15.41) 124.30  (14.79) 123.47  (13.73)
Baseline: diastolic BP Number Analyzed 373 participants 397 participants 186 participants
77.64  (8.97) 77.59  (8.90) 78.02  (8.89)
Month 1: systolic BP Number Analyzed 365 participants 393 participants 184 participants
123.76  (15.28) 124.57  (14.17) 123.41  (14.59)
Month 1: diastolic BP Number Analyzed 365 participants 393 participants 184 participants
77.79  (9.11) 78.30  (8.62) 76.09  (9.00)
Month 2: systolic BP Number Analyzed 361 participants 388 participants 178 participants
123.65  (14.87) 124.28  (13.33) 122.59  (13.89)
Month 2: diastolic BP Number Analyzed 361 participants 388 participants 178 participants
77.77  (9.08) 78.68  (8.81) 76.22  (9.82)
Month 3: systolic BP Number Analyzed 355 participants 383 participants 172 participants
124.08  (14.94) 124.24  (14.40) 122.61  (13.18)
Month 3: diastolic BP Number Analyzed 355 participants 383 participants 172 participants
77.80  (9.19) 78.33  (9.54) 76.52  (7.80)
Month 6: systolic BP Number Analyzed 340 participants 365 participants 158 participants
123.71  (14.56) 125.02  (14.37) 122.28  (12.81)
Month 6: diastolic BP Number Analyzed 340 participants 365 participants 158 participants
77.74  (8.70) 78.56  (8.69) 76.50  (8.32)
Month 9: systolic BP Number Analyzed 328 participants 349 participants 144 participants
123.90  (13.98) 123.89  (13.71) 121.94  (13.01)
Month 9: diastolic BP Number Analyzed 328 participants 349 participants 144 participants
78.01  (9.11) 77.70  (8.38) 76.34  (8.53)
Month 12: systolic BP Number Analyzed 315 participants 331 participants 135 participants
125.61  (15.05) 124.34  (13.68) 122.22  (12.70)
Month 12: diastolic BP Number Analyzed 315 participants 331 participants 135 participants
78.08  (9.14) 78.08  (8.16) 76.59  (8.12)
Month 15: systolic BP Number Analyzed 293 participants 313 participants 128 participants
124.63  (14.24) 124.28  (13.48) 123.71  (13.46)
Month 15: diastolic BP Number Analyzed 293 participants 313 participants 128 participants
77.98  (8.77) 78.04  (8.42) 76.46  (8.95)
Month 18: systolic BP Number Analyzed 284 participants 294 participants 115 participants
124.48  (13.65) 124.39  (12.75) 121.57  (13.08)
Month 18: diastolic BP Number Analyzed 284 participants 294 participants 115 participants
77.66  (8.90) 78.34  (8.02) 76.76  (8.89)
Month 21: systolic BP Number Analyzed 272 participants 290 participants 111 participants
123.83  (13.53) 124.52  (12.91) 123.29  (11.98)
Month 21: diastolic BP Number Analyzed 272 participants 290 participants 111 participants
77.28  (8.24) 78.44  (7.56) 76.45  (8.34)
Month 24: systolic BP Number Analyzed 263 participants 280 participants 105 participants
124.48  (13.15) 124.34  (12.24) 122.47  (12.56)
Month 24: diastolic BP Number Analyzed 264 participants 280 participants 105 participants
78.25  (8.15) 78.07  (7.73) 76.57  (8.46)
5.Primary Outcome
Title Change From Baseline in BP Values (mmHg)
Hide Description BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 365 393 184
Mean (Standard Deviation)
Unit of Measure: mmHg
Month 1: systolic BP Number Analyzed 365 participants 393 participants 184 participants
0.44  (11.70) 0.32  (11.03) -0.02  (11.75)
Month 1: diastolic BP Number Analyzed 365 participants 393 participants 184 participants
0.11  (7.35) 0.78  (7.88) -1.91  (7.96)
Month 2: systolic BP Number Analyzed 361 participants 388 participants 178 participants
0.41  (12.74) 0.07  (12.84) -0.43  (10.93)
Month 2: diastolic BP Number Analyzed 361 participants 388 participants 178 participants
0.13  (8.56) 1.18  (8.86) -1.63  (8.07)
Month 3: systolic BP Number Analyzed 355 participants 383 participants 172 participants
0.91  (13.84) -0.25  (12.71) -0.48  (11.64)
Month 3: diastolic BP Number Analyzed 355 participants 383 participants 172 participants
0.16  (8.70) 0.70  (8.37) -1.31  (8.08)
Month 6: systolic BP Number Analyzed 340 participants 365 participants 158 participants
0.34  (12.60) 0.36  (12.15) -0.97  (10.45)
Month 6: diastolic BP Number Analyzed 340 participants 365 participants 158 participants
-0.04  (8.29) 0.87  (8.34) -1.41  (7.95)
Month 9: systolic BP Number Analyzed 328 participants 349 participants 144 participants
0.35  (12.33) -0.43  (12.52) -1.69  (10.79)
Month 9: diastolic BP Number Analyzed 328 participants 349 participants 144 participants
0.14  (9.12) 0.04  (8.47) -1.79  (8.42)
Month 12: systolic BP Number Analyzed 315 participants 331 participants 135 participants
2.32  (12.94) -0.02  (13.17) -1.36  (11.19)
Month 12: diastolic BP Number Analyzed 315 participants 331 participants 135 participants
0.29  (9.00) 0.37  (8.03) -1.41  (7.25)
Month 15: systolic BP Number Analyzed 293 participants 313 participants 128 participants
0.93  (12.90) -0.00  (13.57) -0.16  (12.14)
Month 15: diastolic BP Number Analyzed 293 participants 313 participants 128 participants
-0.11  (8.98) 0.41  (8.38) -1.63  (8.78)
Month 18: systolic BP Number Analyzed 284 participants 294 participants 115 participants
1.09  (12.61) 0.23  (12.45) -2.38  (13.23)
Month 18: diastolic BP Number Analyzed 284 participants 294 participants 115 participants
-0.30  (8.42) 0.59  (9.09) -1.49  (8.82)
Month 21: systolic BP Number Analyzed 272 participants 290 participants 111 participants
0.49  (13.08) 0.31  (13.68) -0.68  (11.18)
Month 21: diastolic BP Number Analyzed 272 participants 290 participants 111 participants
-0.71  (8.94) 0.65  (9.14) -1.63  (8.06)
Month 24: systolic BP Number Analyzed 263 participants 280 participants 105 participants
1.30  (12.73) 0.06  (13.55) -1.11  (12.42)
Month 24: diastolic BP Number Analyzed 264 participants 280 participants 105 participants
0.38  (8.94) 0.28  (9.62) -1.50  (7.75)
6.Secondary Outcome
Title mTSS Score at Baseline, Months 12 and 24
Hide Description mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Time Frame Baseline, Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, imputation using LEP; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 348 373 171
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 348 participants 373 participants 171 participants
19.05  (38.27) 17.89  (38.49) 16.11  (29.44)
Month 12 Number Analyzed 347 participants 373 participants 171 participants
19.23  (38.37) 18.08  (38.41) 17.32  (30.27)
Month 24 Number Analyzed 348 participants 373 participants 171 participants
19.70  (38.69) 18.23  (38.43) 18.26  (30.99)
7.Secondary Outcome
Title Change From Baseline in mTSS Score at Months 12 and 24
Hide Description mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time Frame Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, imputation using LEP; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 346 371 169
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Month 12 Number Analyzed 345 participants 371 participants 169 participants
0.37  (0.14) 0.17  (0.14) 1.20  (0.20)
Month 24 Number Analyzed 346 participants 371 participants 169 participants
0.57  (0.25) 0.28  (0.24) 2.11  (0.35)
8.Secondary Outcome
Title Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
Hide Description mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.
Time Frame Months 6, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LEP); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 348 373 171
Measure Type: Number
Unit of Measure: percentage of participants
Month 6 Number Analyzed 348 participants 372 participants 167 participants
87.07 89.25 73.65
Month 12 Number Analyzed 347 participants 373 participants 171 participants
82.42 87.67 69.01
Month 24 Number Analyzed 348 participants 373 participants 171 participants
79.89 83.65 64.91
9.Secondary Outcome
Title Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24
Hide Description Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.
Time Frame Months 6, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LEP)
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 348 373 171
Measure Type: Number
Unit of Measure: percentage of participants
Month 6 Number Analyzed 348 participants 372 participants 167 participants
91.67 93.01 81.44
Month 12 Number Analyzed 347 participants 373 participants 171 participants
88.47 90.88 74.85
Month 24 Number Analyzed 348 participants 373 participants 171 participants
85.34 88.20 70.18
10.Secondary Outcome
Title Erosion Scores
Hide Description Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.
Time Frame Baseline, Months 6, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, imputation using LEP
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 348 373 171
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 348 participants 373 participants 171 participants
9.05  (19.00) 9.06  (19.50) 8.38  (15.24)
Month 6 Number Analyzed 348 participants 372 participants 167 participants
9.18  (19.10) 9.15  (19.50) 8.78  (15.54)
Month 12 Number Analyzed 347 participants 373 participants 171 participants
9.05  (18.97) 9.18  (19.42) 8.97  (15.46)
Month 24 Number Analyzed 348 participants 373 participants 171 participants
9.21  (18.95) 9.22  (19.36) 9.37  (15.67)
11.Secondary Outcome
Title JSN Scores
Hide Description JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.
Time Frame Baseline, Months 6, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, imputation using LEP
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 348 373 171
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 348 participants 373 participants 171 participants
10.01  (20.58) 8.82  (19.80) 7.72  (15.28)
Month 6 Number Analyzed 348 participants 372 participants 167 participants
10.09  (20.62) 8.86  (19.79) 8.17  (15.70)
Month 12 Number Analyzed 347 participants 373 participants 171 participants
10.18  (20.74) 8.90  (19.77) 8.35  (16.01)
Month 24 Number Analyzed 348 participants 373 participants 171 participants
10.50  (21.12) 9.01  (19.87) 8.89  (16.76)
12.Secondary Outcome
Title Change From Baseline in Erosion Scores
Hide Description Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame Months 6, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, imputation using LEP
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 348 373 171
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 6 Number Analyzed 348 participants 372 participants 167 participants
0.14  (0.04) 0.10  (0.04) 0.35  (0.06)
Month 12 Number Analyzed 347 participants 373 participants 171 participants
0.13  (0.07) 0.12  (0.06) 0.58  (0.09)
Month 24 Number Analyzed 348 participants 373 participants 171 participants
0.16  (0.11) 0.16  (0.10) 0.98  (0.15)
13.Secondary Outcome
Title Change From Baseline in JSN Scores
Hide Description JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame Months 6, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, imputation using LEP
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 348 373 171
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 6 Number Analyzed 348 participants 372 participants 167 participants
0.06  (0.06) 0.05  (0.06) 0.29  (0.09)
Month 12 Number Analyzed 347 participants 373 participants 171 participants
0.23  (0.10) 0.05  (0.10) 0.60  (0.14)
Month 24 Number Analyzed 348 participants 373 participants 171 participants
0.39  (0.18) 0.12  (0.17) 1.10  (0.25)
14.Secondary Outcome
Title Percentage of Participants Achieving an 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: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI)
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 366 391 182
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 364 participants 390 participants 182 participants
5.22 9.23 0.55
Month 2 Number Analyzed 365 participants 391 participants 182 participants
16.16 23.02 3.30
Month 3 Number Analyzed 366 participants 391 participants 182 participants
19.95 26.60 5.49
Month 9 Number Analyzed 366 participants 391 participants 182 participants
29.23 37.85 13.19
Month 12 Number Analyzed 366 participants 391 participants 182 participants
28.69 37.85 15.38
Month 15 Number Analyzed 366 participants 391 participants 182 participants
30.05 37.85 17.03
Month 18 Number Analyzed 366 participants 391 participants 182 participants
32.24 36.57 15.93
Month 21 Number Analyzed 366 participants 391 participants 182 participants
32.24 36.83 17.58
Month 24 Number Analyzed 366 participants 391 participants 182 participants
34.15 37.60 15.38
15.Secondary Outcome
Title Percentage of Participants Achieving an ACR20 Response
Hide Description ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI)
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 369 394 184
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 367 participants 393 participants 184 participants
49.32 58.27 21.20
Month 2 Number Analyzed 368 participants 394 participants 184 participants
63.59 71.57 42.39
Month 3 Number Analyzed 369 participants 394 participants 184 participants
69.92 77.92 51.63
Month 6 Number Analyzed 369 participants 394 participants 184 participants
71.27 76.14 50.54
Month 9 Number Analyzed 369 participants 394 participants 184 participants
72.09 73.60 55.43
Month 12 Number Analyzed 369 participants 394 participants 184 participants
67.75 71.57 51.09
Month 15 Number Analyzed 369 participants 394 participants 184 participants
68.83 66.24 47.28
Month 18 Number Analyzed 369 participants 394 participants 184 participants
64.23 65.99 46.74
Month 21 Number Analyzed 369 participants 394 participants 184 participants
65.04 62.18 45.11
Month 24 Number Analyzed 369 participants 394 participants 184 participants
64.23 64.21 42.39
16.Secondary Outcome
Title Percentage of Participants Achieving an 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: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI)
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 369 394 184
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 367 participants 393 participants 184 participants
17.98 27.99 3.80
Month 2 Number Analyzed 368 participants 394 participants 184 participants
32.61 40.10 11.41
Month 3 Number Analyzed 369 participants 394 participants 184 participants
40.11 50.00 20.11
Month 6 Number Analyzed 369 participants 394 participants 184 participants
46.61 56.35 26.63
Month 9 Number Analyzed 369 participants 394 participants 184 participants
49.86 56.85 35.33
Month 12 Number Analyzed 369 participants 394 participants 184 participants
49.86 55.58 33.70
Month 15 Number Analyzed 369 participants 394 participants 184 participants
50.68 54.31 33.15
Month 18 Number Analyzed 369 participants 394 participants 184 participants
47.97 51.78 30.43
Month 21 Number Analyzed 369 participants 394 participants 184 participants
49.05 50.51 30.43
Month 24 Number Analyzed 369 participants 394 participants 184 participants
49.32 49.24 28.26
17.Secondary Outcome
Title Tender Joints Count (TJC)
Hide Description Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Mean (Standard Deviation)
Unit of Measure: tender joints
Baseline Number Analyzed 373 participants 397 participants 186 participants
25.65  (13.81) 25.12  (13.51) 25.41  (15.03)
Month 1 Number Analyzed 367 participants 393 participants 184 participants
15.75  (12.98) 13.66  (12.61) 20.07  (14.83)
Month 2 Number Analyzed 361 participants 388 participants 177 participants
12.12  (12.31) 10.67  (12.31) 16.39  (14.16)
Month 3 Number Analyzed 356 participants 383 participants 172 participants
10.03  (11.52) 8.61  (10.67) 14.05  (14.13)
Month 6 Number Analyzed 340 participants 367 participants 158 participants
8.71  (11.04) 6.59  (10.28) 11.99  (13.34)
Month 9 Number Analyzed 328 participants 350 participants 143 participants
7.31  (10.45) 6.14  (10.11) 8.82  (11.27)
Month 12 Number Analyzed 315 participants 332 participants 136 participants
6.60  (9.78) 5.46  (10.16) 9.13  (12.67)
Month 15 Number Analyzed 294 participants 313 participants 129 participants
5.55  (9.15) 5.17  (9.79) 8.23  (10.50)
Month 18 Number Analyzed 284 participants 295 participants 116 participants
5.12  (7.15) 4.46  (7.98) 6.97  (8.74)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
4.60  (6.87) 4.19  (6.40) 7.07  (9.68)
Month 24 Number Analyzed 264 participants 281 participants 106 participants
4.50  (6.75) 4.66  (8.52) 6.01  (6.81)
18.Secondary Outcome
Title Change From Baseline in TJC
Hide Description Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 367 393 184
Least Squares Mean (Standard Error)
Unit of Measure: tender joints
Month 1 Number Analyzed 367 participants 393 participants 184 participants
-9.43  (0.54) -11.40  (0.52) -5.11  (0.75)
Month 2 Number Analyzed 361 participants 388 participants 177 participants
-12.95  (0.54) -14.33  (0.52) -8.63  (0.76)
Month 3 Number Analyzed 356 participants 383 participants 172 participants
-14.95  (0.55) -16.34  (0.52) -10.69  (0.77)
Month 6 Number Analyzed 340 participants 367 participants 158 participants
-16.00  (0.55) -18.09  (0.53) -12.38  (0.79)
Month 9 Number Analyzed 328 participants 350 participants 143 participants
-17.16  (0.56) -18.29  (0.54) -15.39  (0.81)
Month 12 Number Analyzed 315 participants 332 participants 136 participants
-17.85  (0.56) -18.44  (0.54) -14.74  (0.82)
Month 15 Number Analyzed 294 participants 313 participants 129 participants
-18.86  (0.58) -18.57  (0.55) -15.70  (0.83)
Month 18 Number Analyzed 284 participants 295 participants 116 participants
-19.08  (0.58) -19.41  (0.56) -16.41  (0.86)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
-19.54  (0.59) -19.70  (0.57) -16.24  (0.87)
Month 24 Number Analyzed 264 participants 281 participants 106 participants
-19.64  (0.59) -19.23  (0.57) -17.01  (0.89)
19.Secondary Outcome
Title Swollen Joints Count (SJC)
Hide Description Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Mean (Standard Deviation)
Unit of Measure: swollen joints
Baseline Number Analyzed 373 participants 397 participants 186 participants
16.27  (9.24) 15.58  (8.37) 16.76  (10.27)
Month 1 Number Analyzed 367 participants 393 participants 184 participants
9.90  (9.60) 8.02  (7.03) 12.56  (9.40)
Month 2 Number Analyzed 361 participants 388 participants 177 participants
6.84  (7.74) 5.69  (6.29) 9.97  (9.05)
Month 3 Number Analyzed 356 participants 383 participants 172 participants
5.81  (8.76) 4.32  (5.53) 7.88  (7.98)
Month 6 Number Analyzed 340 participants 367 participants 158 participants
4.70  (7.40) 3.69  (6.05) 6.30  (7.12)
Month 9 Number Analyzed 328 participants 350 participants 143 participants
3.83  (5.67) 3.22  (5.93) 4.83  (6.74)
Month 12 Number Analyzed 315 participants 332 participants 136 participants
3.30  (6.12) 2.88  (6.77) 5.17  (9.44)
Month 15 Number Analyzed 294 participants 313 participants 129 participants
2.63  (6.35) 3.00  (7.95) 4.92  (8.21)
Month 18 Number Analyzed 284 participants 295 participants 116 participants
2.44  (4.07) 2.25  (5.28) 3.91  (4.85)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
2.28  (4.12) 2.02  (4.00) 3.47  (4.14)
Month 24 Number Analyzed 264 participants 281 participants 106 participants
2.00  (3.70) 2.29  (6.44) 3.38  (4.26)
20.Secondary Outcome
Title Change From Baseline in SJC
Hide Description Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 367 393 184
Least Squares Mean (Standard Error)
Unit of Measure: swollen joints
Month 1 Number Analyzed 367 participants 393 participants 184 participants
-5.99  (0.36) -7.75  (0.35) -3.55  (0.51)
Month 2 Number Analyzed 361 participants 388 participants 177 participants
-8.95  (0.37) -10.03  (0.35) -5.98  (0.51)
Month 3 Number Analyzed 356 participants 383 participants 172 participants
-9.97  (0.37) -11.42  (0.35) -7.97  (0.52)
Month 6 Number Analyzed 340 participants 367 participants 158 participants
-10.89  (0.37) -11.97  (0.36) -9.35  (0.53)
Month 9 Number Analyzed 328 participants 350 participants 143 participants
-11.47  (0.38) -12.39  (0.36) -11.00  (0.55)
Month 12 Number Analyzed 315 participants 332 participants 136 participants
-11.97  (0.38) -12.54  (0.37) -10.48  (0.56)
Month 15 Number Analyzed 294 participants 313 participants 129 participants
-12.55  (0.39) -12.30  (0.38) -10.69  (0.57)
Month 18 Number Analyzed 284 participants 295 participants 116 participants
-12.63  (0.39) -13.10  (0.38) -11.31  (0.59)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
-12.74  (0.40) -13.28  (0.38) -11.89  (0.60)
Month 24 Number Analyzed 264 participants 281 participants 106 participants
-12.99  (0.40) -13.06  (0.39) -11.96  (0.61)
21.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 analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 373 participants 397 participants 186 participants
59.06  (23.87) 61.37  (23.14) 58.77  (23.58)
Month 1 Number Analyzed 365 participants 392 participants 183 participants
36.62  (23.72) 32.78  (23.31) 46.34  (24.47)
Month 2 Number Analyzed 361 participants 388 participants 178 participants
31.97  (22.94) 30.33  (23.66) 39.74  (23.72)
Month 3 Number Analyzed 352 participants 383 participants 172 participants
29.41  (21.53) 27.07  (21.54) 36.83  (21.99)
Month 6 Number Analyzed 340 participants 366 participants 158 participants
27.07  (21.21) 24.22  (21.53) 30.94  (22.87)
Month 9 Number Analyzed 328 participants 349 participants 143 participants
26.11  (20.35) 23.76  (21.24) 31.22  (22.50)
Month 12 Number Analyzed 315 participants 331 participants 135 participants
26.09  (21.29) 22.64  (20.15) 29.91  (20.76)
Month 15 Number Analyzed 294 participants 313 participants 129 participants
24.25  (20.39) 23.72  (21.97) 29.85  (22.94)
Month 18 Number Analyzed 284 participants 294 participants 116 participants
23.66  (19.29) 22.72  (21.78) 27.81  (20.66)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
23.30  (19.86) 22.85  (21.79) 29.18  (21.46)
Month 24 Number Analyzed 264 participants 280 participants 106 participants
23.03  (19.80) 21.09  (19.32) 27.52  (20.28)
22.Secondary Outcome
Title Change From Baseline in Patient Assessment of Arthritis Pain
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 Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 365 392 183
Least Squares Mean (Standard Error)
Unit of Measure: mm
Month 1 Number Analyzed 365 participants 392 participants 183 participants
-22.98  (1.17) -27.26  (1.12) -13.43  (1.62)
Month 2 Number Analyzed 361 participants 388 participants 178 participants
-27.73  (1.17) -29.71  (1.12) -19.90  (1.64)
Month 3 Number Analyzed 352 participants 383 participants 172 participants
-29.97  (1.18) -32.90  (1.13) -22.22  (1.66)
Month 6 Number Analyzed 340 participants 366 participants 158 participants
-31.94  (1.19) -35.35  (1.15) -27.71  (1.70)
Month 9 Number Analyzed 328 participants 349 participants 143 participants
-32.34  (1.21) -35.26  (1.16) -27.09  (1.75)
Month 12 Number Analyzed 315 participants 331 participants 135 participants
-32.31  (1.22) -35.85  (1.18) -27.76  (1.79)
Month 15 Number Analyzed 293 participants 312 participants 128 participants
-33.71  (1.25) -34.54  (1.20) -28.10  (1.82)
Month 18 Number Analyzed 284 participants 294 participants 116 participants
-34.26  (1.26) -35.73  (1.22) -29.42  (1.87)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
-34.57  (1.27) -35.66  (1.23) -27.87  (1.90)
Month 24 Number Analyzed 264 participants 280 participants 106 participants
-34.78  (1.28) -37.57  (1.24) -29.51  (1.93)
23.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 and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 369 394 185
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 369 participants 394 participants 185 participants
61.97  (16.45) 60.50  (16.93) 59.25  (17.70)
Month 1 Number Analyzed 363 participants 390 participants 183 participants
36.70  (19.24) 33.05  (18.32) 45.52  (19.73)
Month 2 Number Analyzed 360 participants 386 participants 177 participants
27.84  (18.26) 25.80  (17.62) 37.19  (18.61)
Month 3 Number Analyzed 355 participants 383 participants 172 participants
25.06  (17.10) 22.80  (16.36) 32.07  (17.28)
Month 6 Number Analyzed 339 participants 366 participants 158 participants
22.19  (17.31) 18.32  (14.74) 27.25  (16.80)
Month 9 Number Analyzed 328 participants 348 participants 143 participants
18.68  (15.09) 16.61  (15.01) 23.65  (16.55)
Month 12 Number Analyzed 315 participants 330 participants 134 participants
17.63  (15.09) 14.19  (12.63) 22.22  (15.30)
Month 15 Number Analyzed 293 participants 311 participants 127 participants
16.65  (14.03) 14.97  (13.13) 23.29  (17.36)
Month 18 Number Analyzed 282 participants 294 participants 115 participants
16.47  (12.70) 14.02  (12.51) 20.19  (14.74)
Month 21 Number Analyzed 272 participants 288 participants 110 participants
15.73  (12.73) 14.61  (13.39) 20.01  (14.02)
Month 24 Number Analyzed 263 participants 280 participants 106 participants
15.31  (14.14) 14.42  (13.63) 20.04  (15.54)
24.Secondary Outcome
Title Change From Baseline in 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 Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 362 390 183
Least Squares Mean (Standard Error)
Unit of Measure: mm
Month 1 Number Analyzed 362 participants 390 participants 183 participants
-24.89  (0.86) -28.32  (0.82) -15.79  (1.19)
Month 2 Number Analyzed 357 participants 385 participants 177 participants
-33.92  (0.86) -35.49  (0.82) -24.17  (1.20)
Month 3 Number Analyzed 351 participants 380 participants 171 participants
-36.41  (0.87) -38.48  (0.83) -28.62  (1.22)
Month 6 Number Analyzed 336 participants 363 participants 157 participants
-39.04  (0.88) -42.49  (0.84) -33.41  (1.25)
Month 9 Number Analyzed 324 participants 345 participants 142 participants
-42.09  (0.89) -43.94  (0.85) -36.54  (1.29)
Month 12 Number Analyzed 312 participants 328 participants 133 participants
-43.07  (0.90) -46.02  (0.87) -37.43  (1.32)
Month 15 Number Analyzed 291 participants 309 participants 126 participants
-43.91  (0.92) -45.40  (0.88) -36.17  (1.34)
Month 18 Number Analyzed 281 participants 292 participants 114 participants
-44.00  (0.93) -46.50  (0.90) -38.65  (1.38)
Month 21 Number Analyzed 270 participants 288 participants 109 participants
-44.76  (0.94) -46.02  (0.90) -38.92  (1.40)
Month 24 Number Analyzed 261 participants 279 participants 105 participants
-45.07  (0.95) -46.30  (0.91) -38.93  (1.42)
25.Secondary Outcome
Title Patient Global Assessment 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=very well and 100=very poorly.
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 373 participants 397 participants 186 participants
60.20  (24.56) 60.88  (22.65) 57.71  (24.30)
Month 1 Number Analyzed 365 participants 392 participants 183 participants
38.27  (24.83) 32.63  (23.09) 46.15  (22.82)
Month 2 Number Analyzed 361 participants 388 participants 178 participants
31.91  (22.90) 28.94  (22.63) 41.29  (22.73)
Month 3 Number Analyzed 353 participants 383 participants 172 participants
30.36  (21.78) 28.60  (22.21) 37.43  (21.20)
Month 6 Number Analyzed 340 participants 366 participants 158 participants
28.37  (21.23) 24.84  (21.61) 32.12  (21.92)
Month 9 Number Analyzed 328 participants 349 participants 143 participants
26.73  (20.38) 24.98  (22.30) 32.79  (22.42)
Month 12 Number Analyzed 315 participants 330 participants 135 participants
26.72  (20.84) 24.38  (22.34) 32.40  (21.69)
Month 15 Number Analyzed 293 participants 312 participants 128 participants
25.19  (20.12) 23.79  (21.96) 32.26  (22.79)
Month 18 Number Analyzed 284 participants 294 participants 115 participants
24.76  (19.93) 24.38  (22.59) 29.31  (20.91)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
24.72  (20.93) 23.86  (21.52) 30.19  (21.15)
Month 24 Number Analyzed 264 participants 280 participants 106 participants
24.42  (21.43) 23.61  (20.86) 28.81  (20.54)
26.Secondary Outcome
Title Change From Baseline in Patient Global Assessment 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=very well and 100=very poorly.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 365 392 183
Least Squares Mean (Standard Error)
Unit of Measure: mm
Month 1 Number Analyzed 365 participants 392 participants 183 participants
-22.22  (1.17) -27.87  (1.12) -14.12  (1.62)
Month 2 Number Analyzed 361 participants 388 participants 178 participants
-28.74  (1.17) -31.54  (1.12) -18.86  (1.64)
Month 3 Number Analyzed 353 participants 383 participants 172 participants
-30.03  (1.18) -31.72  (1.13) -22.18  (1.66)
Month 6 Number Analyzed 340 participants 366 participants 158 participants
-31.65  (1.19) -35.11  (1.15) -27.00  (1.70)
Month 9 Number Analyzed 328 participants 349 participants 143 participants
-32.70  (1.21) -34.48  (1.16) -26.15  (1.76)
Month 12 Number Analyzed 315 participants 330 participants 135 participants
-32.75  (1.22) -34.62  (1.18) -26.07  (1.79)
Month 15 Number Analyzed 293 participants 312 participants 128 participants
-33.82  (1.25) -34.94  (1.20) -26.70  (1.82)
Month 18 Number Analyzed 284 participants 294 participants 116 participants
-34.18  (1.26) -34.65  (1.22) -28.64  (1.87)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
-34.18  (1.27) -35.26  (1.23) -27.56  (1.90)
Month 24 Number Analyzed 264 participants 280 participants 106 participants
-34.41  (1.29) -35.74  (1.24) -28.81  (1.93)
27.Secondary Outcome
Title C-Reactive Protein
Hide Description CRP measured in milligrams per liter (mg/L)
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline Number Analyzed 373 participants 397 participants 186 participants
22.68  (27.09) 20.25  (23.92) 25.92  (30.94)
Month 1 Number Analyzed 366 participants 390 participants 184 participants
6.62  (9.68) 3.23  (5.35) 17.37  (24.26)
Month 2 Number Analyzed 360 participants 386 participants 176 participants
6.47  (15.24) 3.48  (9.38) 16.12  (26.55)
Month 3 Number Analyzed 353 participants 384 participants 172 participants
6.75  (12.81) 3.05  (5.60) 11.90  (17.11)
Month 6 Number Analyzed 339 participants 366 participants 158 participants
5.22  (11.56) 3.14  (5.51) 12.21  (19.32)
Month 9 Number Analyzed 327 participants 349 participants 143 participants
6.01  (12.89) 3.39  (6.32) 8.18  (12.36)
Month 12 Number Analyzed 314 participants 330 participants 135 participants
5.26  (9.93) 2.72  (4.46) 9.64  (16.36)
Month 15 Number Analyzed 290 participants 311 participants 128 participants
5.57  (15.52) 2.96  (4.40) 8.61  (13.02)
Month 18 Number Analyzed 280 participants 291 participants 116 participants
4.57  (8.71) 3.59  (11.42) 8.98  (11.72)
Month 21 Number Analyzed 272 participants 288 participants 111 participants
4.89  (7.58) 4.07  (8.12) 9.54  (13.72)
Month 24 Number Analyzed 262 participants 279 participants 103 participants
5.57  (11.49) 3.71  (7.00) 10.07  (17.04)
28.Secondary Outcome
Title Change From Baseline in CRP
Hide Description Change from Baseline in CRP measured in mg/L.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 366 390 184
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
Month 1 Number Analyzed 366 participants 390 participants 184 participants
-15.64  (0.68) -18.84  (0.66) -5.55  (0.95)
Month 2 Number Analyzed 360 participants 386 participants 176 participants
-16.02  (0.69) -18.59  (0.66) -6.83  (0.97)
Month 3 Number Analyzed 353 participants 384 participants 172 participants
-15.69  (0.69) -19.01  (0.66) -9.86  (0.97)
Month 6 Number Analyzed 339 participants 366 participants 158 participants
-16.98  (0.70) -18.76  (0.67) -9.68  (1.00)
Month 9 Number Analyzed 328 participants 349 participants 143 participants
-16.03  (0.71) -18.48  (0.68) -12.75  (1.03)
Month 12 Number Analyzed 314 participants 330 participants 135 participants
-16.58  (0.72) -19.16  (0.69) -11.12  (1.05)
Month 15 Number Analyzed 290 participants 311 participants 128 participants
-16.10  (0.73) -18.80  (0.70) -12.35  (1.07)
Month 18 Number Analyzed 280 participants 291 participants 116 participants
-17.06  (0.74) -18.17  (0.72) -11.62  (1.10)
Month 21 Number Analyzed 272 participants 288 participants 111 participants
-16.83  (0.75) -17.67  (0.72) -11.07  (1.11)
Month 24 Number Analyzed 262 participants 279 participants 103 participants
-15.97  (0.75) -17.96  (0.73) -10.31  (1.14)
29.Secondary Outcome
Title Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP
Hide Description DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 373 participants 397 participants 186 participants
5.56  (0.91) 5.46  (0.94) 5.62  (0.95)
Month 1 Number Analyzed 366 participants 389 participants 184 participants
4.21  (1.08) 3.77  (1.09) 4.96  (1.17)
Month 2 Number Analyzed 359 participants 386 participants 176 participants
3.67  (1.21) 3.31  (1.18) 4.50  (1.19)
Month 3 Number Analyzed 353 participants 383 participants 171 participants
3.41  (1.21) 3.05  (1.12) 4.14  (1.27)
Month 6 Number Analyzed 339 participants 366 participants 158 participants
3.21  (1.25) 2.76  (1.08) 3.85  (1.34)
Month 9 Number Analyzed 327 participants 349 participants 143 participants
3.05  (1.22) 2.69  (1.15) 3.49  (1.20)
Month 12 Number Analyzed 313 participants 330 participants 135 participants
2.92  (1.18) 2.52  (1.07) 3.42  (1.30)
Month 15 Number Analyzed 289 participants 311 participants 128 participants
2.78  (1.10) 2.50  (1.12) 3.38  (1.27)
Month 18 Number Analyzed 279 participants 291 participants 116 participants
2.70  (1.06) 2.47  (0.98) 3.32  (1.17)
Month 21 Number Analyzed 272 participants 288 participants 111 participants
2.67  (1.10) 2.48  (1.07) 3.33  (1.27)
Month 24 Number Analyzed 263 participants 279 participants 104 participants
2.65  (1.08) 2.44  (1.03) 3.22  (1.15)
30.Secondary Outcome
Title Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Hide Description DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 372 397 186
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 372 participants 397 participants 186 participants
6.62  (0.98) 6.54  (0.96) 6.60  (1.02)
Month 1 Number Analyzed 338 participants 369 participants 167 participants
5.18  (1.28) 4.70  (1.32) 5.84  (1.24)
Month 2 Number Analyzed 333 participants 366 participants 163 participants
4.54  (1.45) 4.17  (1.39) 5.35  (1.24)
Month 3 Number Analyzed 329 participants 360 participants 159 participants
4.21  (1.45) 3.94  (1.31) 4.98  (1.37)
Month 6 Number Analyzed 319 participants 345 participants 146 participants
4.05  (1.44) 3.62  (1.31) 4.61  (1.48)
Month 9 Number Analyzed 305 participants 329 participants 132 participants
3.84  (1.37) 3.53  (1.36) 4.27  (1.36)
Month 12 Number Analyzed 292 participants 309 participants 123 participants
3.69  (1.33) 3.37  (1.29) 4.23  (1.38)
Month 15 Number Analyzed 276 participants 293 participants 116 participants
3.59  (1.23) 3.32  (1.31) 4.17  (1.46)
Month 18 Number Analyzed 264 participants 272 participants 106 participants
3.51  (1.22) 3.33  (1.18) 4.05  (1.37)
Month 21 Number Analyzed 254 participants 269 participants 100 participants
3.49  (1.26) 3.33  (1.29) 4.09  (1.39)
Month 24 Number Analyzed 238 participants 254 participants 92 participants
3.43  (1.25) 3.29  (1.29) 3.99  (1.33)
31.Secondary Outcome
Title Change From Baseline in DAS28-3(CRP)
Hide Description DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 366 389 184
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 366 participants 389 participants 184 participants
-1.30  (0.06) -1.71  (0.06) -0.58  (0.08)
Month 2 Number Analyzed 359 participants 386 participants 176 participants
-1.85  (0.06) -2.16  (0.06) -1.02  (0.08)
Month 3 Number Analyzed 353 participants 383 participants 171 participants
-2.09  (0.06) -2.42  (0.06) -1.36  (0.08)
Month 6 Number Analyzed 339 participants 366 participants 158 participants
-2.27  (0.06) -2.68  (0.06) -1.62  (0.09)
Month 9 Number Analyzed 327 participants 349 participants 143 participants
-2.40  (0.06) -2.72  (0.06) -1.95  (0.09)
Month 12 Number Analyzed 313 participants 330 participants 135 participants
-2.52  (0.06) -2.85  (0.06) -1.99  (0.09)
Month 15 Number Analyzed 289 participants 311 participants 128 participants
-2.65  (0.06) -2.85  (0.06) -2.03  (0.09)
Month 18 Number Analyzed 279 participants 291 participants 116 participants
-2.72  (0.06) -2.91  (0.06) -2.05  (0.10)
Month 21 Number Analyzed 272 participants 288 participants 111 participants
-2.75  (0.06) -2.89  (0.06) -2.05  (0.10)
Month 24 Number Analyzed 263 participants 279 participants 104 participants
-2.76  (0.07) -2.94  (0.06) -2.12  (0.10)
32.Secondary Outcome
Title Change From Baseline in DAS28-4(ESR)
Hide Description DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 338 369 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 338 participants 369 participants 167 participants
-1.40  (0.07) -1.83  (0.07) -0.72  (0.10)
Month 2 Number Analyzed 333 participants 366 participants 163 participants
-2.03  (0.07) -2.36  (0.07) -1.17  (0.10)
Month 3 Number Analyzed 329 participants 360 participants 159 participants
-2.34  (0.07) -2.59  (0.07) -1.53  (0.10)
Month 6 Number Analyzed 319 participants 345 participants 146 participants
-2.47  (0.07) -2.88  (0.07) -1.87  (0.10)
Month 9 Number Analyzed 305 participants 329 participants 132 participants
-2.64  (0.07) -2.93  (0.07) -2.19  (0.10)
Month 12 Number Analyzed 292 participants 309 participants 123 participants
-2.78  (0.07) -3.05  (0.07) -2.20  (0.11)
Month 15 Number Analyzed 276 participants 293 participants 116 participants
-2.87  (0.07) -3.08  (0.07) -2.25  (0.11)
Month 18 Number Analyzed 264 participants 272 participants 106 participants
-2.92  (0.07) -3.09  (0.07) -2.34  (0.11)
Month 21 Number Analyzed 254 participants 269 participants 100 participants
-2.96  (0.08) -3.10  (0.07) -2.30  (0.11)
Month 24 Number Analyzed 238 participants 254 participants 92 participants
-2.99  (0.08) -3.16  (0.07) -2.40  (0.12)
33.Secondary Outcome
Title Percentage of Participants With DAS28-3(CRP) ≤3.2
Hide Description DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 367 394 184
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 366 participants 389 participants 184 participants
16.67 33.16 5.98
Month 2 Number Analyzed 367 participants 394 participants 184 participants
35.42 47.97 14.13
Month 3 Number Analyzed 367 participants 394 participants 184 participants
40.33 56.85 19.57
Month 6 Number Analyzed 367 participants 394 participants 184 participants
47.68 62.69 27.72
Month 9 Number Analyzed 367 participants 394 participants 184 participants
52.04 60.41 33.15
Month 12 Number Analyzed 367 participants 394 participants 184 participants
52.59 64.97 32.61
Month 15 Number Analyzed 367 participants 394 participants 184 participants
53.41 58.88 29.89
Month 18 Number Analyzed 367 participants 394 participants 184 participants
52.59 56.09 25.00
Month 21 Number Analyzed 367 participants 394 participants 184 participants
52.59 55.84 28.26
Month 24 Number Analyzed 367 participants 394 participants 184 participants
52.32 56.85 29.35
34.Secondary Outcome
Title Percentage of Participants With DAS28-4(ESR) ≤3.2
Hide Description DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 342 372 171
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 338 participants 369 participants 167 participants
7.40 14.09 2.99
Month 2 Number Analyzed 342 participants 372 participants 170 participants
18.42 25.81 4.71
Month 3 Number Analyzed 342 participants 372 participants 171 participants
25.15 30.38 9.94
Month 6 Number Analyzed 342 participants 372 participants 171 participants
27.78 38.17 14.04
Month 9 Number Analyzed 342 participants 372 participants 171 participants
29.24 39.78 18.13
Month 12 Number Analyzed 342 participants 372 participants 171 participants
33.33 41.13 18.71
Month 15 Number Analyzed 342 participants 372 participants 171 participants
33.04 40.86 18.13
Month 18 Number Analyzed 342 participants 372 participants 171 participants
32.16 35.22 16.37
Month 21 Number Analyzed 342 participants 372 participants 171 participants
34.21 38.17 16.37
Month 24 Number Analyzed 342 participants 372 participants 171 participants
34.80 36.02 15.79
35.Secondary Outcome
Title Percentage of Participants With DAS28-3(CRP) <2.6
Hide Description DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 367 394 184
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 366 participants 389 participants 184 participants
7.38 14.14 2.72
Month 2 Number Analyzed 367 participants 394 participants 184 participants
20.44 28.68 5.43
Month 3 Number Analyzed 367 participants 394 participants 184 participants
25.89 37.82 9.78
Month 6 Number Analyzed 367 participants 394 participants 184 participants
31.34 47.21 15.22
Month 9 Number Analyzed 367 participants 394 participants 184 participants
36.24 45.69 17.39
Month 12 Number Analyzed 367 participants 394 participants 184 participants
36.51 49.49 20.65
Month 15 Number Analyzed 367 participants 394 participants 184 participants
37.60 49.24 19.57
Month 18 Number Analyzed 367 participants 394 participants 184 participants
38.42 44.67 19.02
Month 21 Number Analyzed 367 participants 394 participants 184 participants
37.06 44.67 17.39
Month 24 Number Analyzed 367 participants 394 participants 184 participants
38.42 43.91 18.48
36.Secondary Outcome
Title Percentage of Participants With DAS28-4(ESR) <2.6
Hide Description DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 342 372 171
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 338 participants 369 participants 167 participants
2.07 5.69 0.00
Month 2 Number Analyzed 342 participants 372 participants 170 participants
9.06 12.90 2.35
Month 3 Number Analyzed 342 participants 372 participants 171 participants
13.74 17.47 4.68
Month 6 Number Analyzed 342 participants 372 participants 171 participants
14.62 21.77 7.60
Month 9 Number Analyzed 342 participants 372 participants 171 participants
16.37 23.66 9.94
Month 12 Number Analyzed 342 participants 372 participants 171 participants
18.71 23.39 11.70
Month 15 Number Analyzed 342 participants 372 participants 171 participants
16.37 24.19 12.87
Month 18 Number Analyzed 342 participants 372 participants 171 participants
16.96 19.89 11.11
Month 21 Number Analyzed 342 participants 372 participants 171 participants
18.42 21.42 8.77
Month 24 Number Analyzed 342 participants 372 participants 171 participants
20.76 22.31 9.94
37.Secondary Outcome
Title Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)
Hide Description DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 367 394 184
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 366 participants 389 participants 184 participants
71.86 80.46 37.50
Month 2 Number Analyzed 367 participants 394 participants 184 participants
80.11 85.79 58.15
Month 3 Number Analyzed 367 participants 394 participants 184 participants
83.65 89.34 68.48
Month 6 Number Analyzed 367 participants 394 participants 184 participants
82.83 85.03 64.13
Month 9 Number Analyzed 367 participants 394 participants 184 participants
80.38 82.74 64.13
Month 12 Number Analyzed 367 participants 394 participants 184 participants
76.29 78.68 60.87
Month 15 Number Analyzed 367 participants 394 participants 184 participants
75.20 73.35 59.24
Month 18 Number Analyzed 367 participants 394 participants 184 participants
73.02 71.57 55.98
Month 21 Number Analyzed 367 participants 394 participants 184 participants
69.48 69.29 50.54
Month 24 Number Analyzed 367 participants 394 participants 184 participants
68.94 69.80 49.46
38.Secondary Outcome
Title Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)
Hide Description DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 342 372 171
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 338 participants 369 participants 167 participants
62.43 74.25 33.53
Month 2 Number Analyzed 342 participants 372 participants 170 participants
74.27 82.26 50.00
Month 3 Number Analyzed 342 participants 372 participants 171 participants
80.41 88.17 66.67
Month 6 Number Analyzed 342 participants 372 participants 171 participants
78.95 84.14 60.82
Month 9 Number Analyzed 342 participants 372 participants 171 participants
78.36 81.72 61.40
Month 12 Number Analyzed 342 participants 372 participants 171 participants
76.61 79.57 59.65
Month 15 Number Analyzed 342 participants 372 participants 171 participants
74.85 73.12 56.73
Month 18 Number Analyzed 342 participants 372 participants 171 participants
70.18 70.97 52.05
Month 21 Number Analyzed 342 participants 372 participants 171 participants
69.88 69.89 48.54
Month 24 Number Analyzed 342 participants 372 participants 171 participants
68.71 69.62 49.12
39.Secondary Outcome
Title Percentage of Participants With an ACR70 Response Sustained at Least 6 Months
Hide Description ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame Months 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, no imputation.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Measure Type: Number
Unit of Measure: percentage of participants
28.42 38.54 13.98
40.Secondary Outcome
Title Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits
Hide Description ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame Months 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, no imputation.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 8.6 6.5 7.5
3 consecutive visits 8.6 11.1 14.5
4 consecutive visits 5.6 6.8 10.2
5 consecutive visits 7.0 4.3 5.4
6 consecutive visits 6.7 6.0 4.8
7 consecutive visits 6.7 6.8 5.9
8 consecutive visits 9.4 4.5 5.4
9 consecutive visits 9.7 11.6 9.7
10 consecutive visits 23.6 30.5 4.8
41.Secondary Outcome
Title Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits
Hide Description ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame Months 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, no imputation.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 9.9 9.8 9.1
3 consecutive visits 10.7 9.1 8.1
4 consecutive visits 6.4 7.3 5.4
5 consecutive visits 9.7 5.3 3.2
6 consecutive visits 4.6 4.8 5.4
7 consecutive visits 6.2 6.0 5.9
8 consecutive visits 5.6 7.1 2.2
9 consecutive visits 5.6 8.3 1.6
10 consecutive visits 5.9 11.8 1.1
42.Secondary Outcome
Title Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits
Hide Description ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time Frame Months 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, no imputation.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 10.7 8.8 5.9
3 consecutive visits 5.9 7.8 3.8
4 consecutive visits 5.4 6.0 4.3
5 consecutive visits 4.3 5.8 1.6
6 consecutive visits 3.8 3.3 1.1
7 consecutive visits 2.9 4.8 2.7
8 consecutive visits 2.9 4.0 NA [1] 
9 consecutive visits 3.2 5.8 1.1
10 consecutive visits 1.3 2.8 0
[1]
Values less than 1% were grouped and specific values labelled as ‘not applicable’. Only 1 participant met this category
43.Secondary Outcome
Title Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits
Hide Description DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Time Frame Months 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, no imputation.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 10.2 10.6 7.0
3 consecutive visits 8.6 8.6 7.0
4 consecutive visits 6.4 7.3 3.8
5 consecutive visits 5.1 5.5 4.3
6 consecutive visits 5.4 4.0 1.1
7 consecutive visits 4.0 7.3 1.6
8 consecutive visits 3.2 6.5 1.1
9 consecutive visits 4.0 7.6 NA [1] 
10 consecutive visits 1.3 2.8 NA [1] 
[1]
Values less than 1% were grouped and specific values labelled as ‘not applicable’. Only 1 participant met this category
44.Secondary Outcome
Title Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits
Hide Description DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Time Frame Months 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, no imputation.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 397 186
Measure Type: Number
Unit of Measure: percentage of participants
2 consecutive visits 6.2 7.6 4.3
3 consecutive visits 5.4 5.3 2.7
4 consecutive visits 4.0 4.0 3.2
5 consecutive visits NA [1]  1.3 1.6
6 consecutive visits 2.4 2.0 NA [2] 
7 consecutive visits 1.9 3.0 NA [2] 
8 consecutive visits NA [1]  2.0 0
9 consecutive visits NA [1]  2.5 1.1
10 consecutive visits NA [1]  NA [3]  0
[1]
Values less than 1% were grouped and specific values labelled as ‘not applicable’. Only 2 participants met this category
[2]
Values less than 1% were grouped and specific values labelled as ‘not applicable’. Only 1 participant met this category
[3]
Values less than 1% were grouped and specific values labelled as ‘not applicable’. Only 3 participants met this category
45.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, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 373 396 186
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 373 participants 396 participants 186 participants
1.54  (0.65) 1.50  (0.67) 1.52  (0.65)
Month 1 Number Analyzed 365 participants 392 participants 184 participants
1.05  (0.67) 0.89  (0.65) 1.30  (0.67)
Month 2 Number Analyzed 361 participants 388 participants 178 participants
0.89  (0.67) 0.74  (0.62) 1.17  (0.66)
Month 3 Number Analyzed 354 participants 383 participants 171 participants
0.78  (0.64) 0.67  (0.63) 1.03  (0.63)
Month 6 Number Analyzed 340 participants 366 participants 158 participants
0.69  (0.64) 0.57  (0.59) 0.92  (0.62)
Month 9 Number Analyzed 328 participants 349 participants 143 participants
0.66  (0.62) 0.56  (0.58) 0.83  (0.57)
Month 12 Number Analyzed 315 participants 331 participants 135 participants
0.64  (0.61) 0.51  (0.56) 0.79  (0.58)
Month 15 Number Analyzed 293 participants 312 participants 127 participants
0.59  (0.59) 0.51  (0.56) 0.83  (0.64)
Month 18 Number Analyzed 284 participants 294 participants 116 participants
0.58  (0.58) 0.48  (0.55) 0.74  (0.60)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
0.59  (0.58) 0.49  (0.56) 0.76  (0.64)
Month 24 Number Analyzed 264 participants 280 participants 106 participants
0.58  (0.60) 0.48  (0.56) 0.77  (0.64)
46.Secondary Outcome
Title Change From Baseline in HAQ-DI Score
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 365 391 184
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 365 participants 391 participants 184 participants
-0.48  (0.03) -0.62  (0.03) -0.23  (0.04)
Month 2 Number Analyzed 361 participants 387 participants 178 participants
-0.65  (0.03) -0.77  (0.03) -0.35  (0.4)
Month 3 Number Analyzed 354 participants 382 participants 171 participants
-0.75  (0.03) -0.85  (0.03) -0.47  (0.04)
Month 6 Number Analyzed 340 participants 365 participants 158 participants
-0.83  (0.03) -0.94  (0.03) -0.58  (0.04)
Month 9 Number Analyzed 328 participants 348 participants 143 participants
-0.85  (0.03) -0.95  (0.03) -0.65  (0.04)
Month 12 Number Analyzed 315 participants 330 participants 135 participants
-0.87  (0.03) -0.98  (0.03) -0.68  (0.04)
Month 15 Number Analyzed 293 participants 311 participants 127 participants
-0.90  (0.03) -0.98  (0.03) -0.65  (0.05)
Month 18 Number Analyzed 284 participants 294 participants 116 participants
-0.90  (0.03) -1.01  (0.03) -0.74  (0.05)
Month 21 Number Analyzed 273 participants 290 participants 111 participants
-0.90  (0.03) -1.00  (0.03) -0.72  (0.05)
Month 24 Number Analyzed 264 participants 280 participants 106 participants
-0.90  (0.03) -1.01  (0.03) -0.70  (0.05)
47.Secondary Outcome
Title Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 366 392 184
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 365 participants 391 participants 184 participants
64.38 73.91 45.65
Month 2 Number Analyzed 366 participants 392 participants 184 participants
69.13 79.85 61.41
Month 3 Number Analyzed 366 participants 392 participants 184 participants
72.95 80.36 65.22
Month 6 Number Analyzed 366 participants 392 participants 184 participants
74.32 77.81 63.04
Month 9 Number Analyzed 366 participants 392 participants 184 participants
73.50 73.21 61.41
Month 12 Number Analyzed 366 participants 392 participants 184 participants
68.03 71.43 58.70
Month 15 Number Analyzed 366 participants 392 participants 184 participants
65.30 67.86 51.63
Month 18 Number Analyzed 366 participants 392 participants 184 participants
64.21 64.80 48.91
Month 21 Number Analyzed 366 participants 392 participants 184 participants
62.30 65.05 46.74
Month 24 Number Analyzed 366 participants 392 participants 184 participants
60.11 65.05 46.74
48.Secondary Outcome
Title Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID MTX 10, 15, or 20 mg, Weekly
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
Overall Number of Participants Analyzed 366 392 184
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 365 participants 391 participants 184 participants
54.79 65.73 32.61
Month 2 Number Analyzed 366 participants 392 participants 184 participants
62.30 73.21 47.83
Month 3 Number Analyzed 366 participants