Trial Outcomes & Findings for 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 (NCT NCT01039688)

Last Updated: 2018-04-06

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

956 participants

Primary outcome timeframe

Month 6

Results posted on

2018-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550 5 mg Twice Daily (BID) 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.	CP-690,550 10 mg BID 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.	MTX 10, 15, or 20 mg, Weekly 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 Study STARTED	373	397	186
Overall Study COMPLETED	266	286	106
Overall Study NOT COMPLETED	107	111	80

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 5 mg Twice Daily (BID) 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.	CP-690,550 10 mg BID 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.	MTX 10, 15, or 20 mg, Weekly 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 Study Adverse Event	38	39	24
Overall Study Lack of Efficacy	20	11	26
Overall Study Lost to Follow-up	11	9	5
Overall Study Other	13	25	12
Overall Study Withdrawal by Subject	23	27	13
Overall Study Death	2	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 5 mg Twice Daily (BID) n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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 n=956 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 12.2 • n=5 Participants	49.3 years STANDARD_DEVIATION 12.8 • n=7 Participants	48.8 years STANDARD_DEVIATION 13.3 • n=5 Participants	49.6 years STANDARD_DEVIATION 12.7 • n=4 Participants
Sex: Female, Male Female	286 Participants n=5 Participants	327 Participants n=7 Participants	145 Participants n=5 Participants	758 Participants n=4 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	70 Participants n=7 Participants	41 Participants n=5 Participants	198 Participants n=4 Participants

PRIMARY outcome

Timeframe: Month 6

Population: 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.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=346 Participants 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.	CP-690,550 10 mg BID n=369 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=166 Participants 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.
Modified Total Sharp Score (mTSS) at Month 6	20.50 score on a scale Standard Error 40.58	18.85 score on a scale Standard Error 39.21	17.54 score on a scale Standard Error 29.96

PRIMARY outcome

Timeframe: Month 6

Population: FAS, imputation using LEP

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=346 Participants 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.	CP-690,550 10 mg BID n=370 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=165 Participants 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.
Change From Baseline at Month 6 in mTSS	0.20 score on a scale Standard Error 0.09	0.15 score on a scale Standard Error 0.08	0.65 score on a scale Standard Error 0.12

PRIMARY outcome

Timeframe: Month 6

Population: FAS. Missing values due to participant withdrawal were imputed using nonresponder imputation (NRI) method.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=366 Participants 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.	CP-690,550 10 mg BID n=391 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=182 Participants 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.
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6	25.41 percentage of participants	37.34 percentage of participants	12.09 percentage of participants

PRIMARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Absolute Blood Pressure (BP) Values (mmHg) Month 24: systolic BP	124.48 mmHg Standard Deviation 13.15	124.34 mmHg Standard Deviation 12.24	122.47 mmHg Standard Deviation 12.56
Absolute Blood Pressure (BP) Values (mmHg) Month 24: diastolic BP	78.25 mmHg Standard Deviation 8.15	78.07 mmHg Standard Deviation 7.73	76.57 mmHg Standard Deviation 8.46
Absolute Blood Pressure (BP) Values (mmHg) Baseline: systolic BP	123.37 mmHg Standard Deviation 15.41	124.30 mmHg Standard Deviation 14.79	123.47 mmHg Standard Deviation 13.73
Absolute Blood Pressure (BP) Values (mmHg) Baseline: diastolic BP	77.64 mmHg Standard Deviation 8.97	77.59 mmHg Standard Deviation 8.90	78.02 mmHg Standard Deviation 8.89
Absolute Blood Pressure (BP) Values (mmHg) Month 1: systolic BP	123.76 mmHg Standard Deviation 15.28	124.57 mmHg Standard Deviation 14.17	123.41 mmHg Standard Deviation 14.59
Absolute Blood Pressure (BP) Values (mmHg) Month 1: diastolic BP	77.79 mmHg Standard Deviation 9.11	78.30 mmHg Standard Deviation 8.62	76.09 mmHg Standard Deviation 9.00
Absolute Blood Pressure (BP) Values (mmHg) Month 2: systolic BP	123.65 mmHg Standard Deviation 14.87	124.28 mmHg Standard Deviation 13.33	122.59 mmHg Standard Deviation 13.89
Absolute Blood Pressure (BP) Values (mmHg) Month 2: diastolic BP	77.77 mmHg Standard Deviation 9.08	78.68 mmHg Standard Deviation 8.81	76.22 mmHg Standard Deviation 9.82
Absolute Blood Pressure (BP) Values (mmHg) Month 3: systolic BP	124.08 mmHg Standard Deviation 14.94	124.24 mmHg Standard Deviation 14.40	122.61 mmHg Standard Deviation 13.18
Absolute Blood Pressure (BP) Values (mmHg) Month 3: diastolic BP	77.80 mmHg Standard Deviation 9.19	78.33 mmHg Standard Deviation 9.54	76.52 mmHg Standard Deviation 7.80
Absolute Blood Pressure (BP) Values (mmHg) Month 6: systolic BP	123.71 mmHg Standard Deviation 14.56	125.02 mmHg Standard Deviation 14.37	122.28 mmHg Standard Deviation 12.81
Absolute Blood Pressure (BP) Values (mmHg) Month 6: diastolic BP	77.74 mmHg Standard Deviation 8.70	78.56 mmHg Standard Deviation 8.69	76.50 mmHg Standard Deviation 8.32
Absolute Blood Pressure (BP) Values (mmHg) Month 9: systolic BP	123.90 mmHg Standard Deviation 13.98	123.89 mmHg Standard Deviation 13.71	121.94 mmHg Standard Deviation 13.01
Absolute Blood Pressure (BP) Values (mmHg) Month 9: diastolic BP	78.01 mmHg Standard Deviation 9.11	77.70 mmHg Standard Deviation 8.38	76.34 mmHg Standard Deviation 8.53
Absolute Blood Pressure (BP) Values (mmHg) Month 12: systolic BP	125.61 mmHg Standard Deviation 15.05	124.34 mmHg Standard Deviation 13.68	122.22 mmHg Standard Deviation 12.70
Absolute Blood Pressure (BP) Values (mmHg) Month 12: diastolic BP	78.08 mmHg Standard Deviation 9.14	78.08 mmHg Standard Deviation 8.16	76.59 mmHg Standard Deviation 8.12
Absolute Blood Pressure (BP) Values (mmHg) Month 15: systolic BP	124.63 mmHg Standard Deviation 14.24	124.28 mmHg Standard Deviation 13.48	123.71 mmHg Standard Deviation 13.46
Absolute Blood Pressure (BP) Values (mmHg) Month 15: diastolic BP	77.98 mmHg Standard Deviation 8.77	78.04 mmHg Standard Deviation 8.42	76.46 mmHg Standard Deviation 8.95
Absolute Blood Pressure (BP) Values (mmHg) Month 18: systolic BP	124.48 mmHg Standard Deviation 13.65	124.39 mmHg Standard Deviation 12.75	121.57 mmHg Standard Deviation 13.08
Absolute Blood Pressure (BP) Values (mmHg) Month 18: diastolic BP	77.66 mmHg Standard Deviation 8.90	78.34 mmHg Standard Deviation 8.02	76.76 mmHg Standard Deviation 8.89
Absolute Blood Pressure (BP) Values (mmHg) Month 21: systolic BP	123.83 mmHg Standard Deviation 13.53	124.52 mmHg Standard Deviation 12.91	123.29 mmHg Standard Deviation 11.98
Absolute Blood Pressure (BP) Values (mmHg) Month 21: diastolic BP	77.28 mmHg Standard Deviation 8.24	78.44 mmHg Standard Deviation 7.56	76.45 mmHg Standard Deviation 8.34

PRIMARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=365 Participants 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.	CP-690,550 10 mg BID n=393 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Change From Baseline in BP Values (mmHg) Month 1: systolic BP	0.44 mmHg Standard Deviation 11.70	0.32 mmHg Standard Deviation 11.03	-0.02 mmHg Standard Deviation 11.75
Change From Baseline in BP Values (mmHg) Month 1: diastolic BP	0.11 mmHg Standard Deviation 7.35	0.78 mmHg Standard Deviation 7.88	-1.91 mmHg Standard Deviation 7.96
Change From Baseline in BP Values (mmHg) Month 2: systolic BP	0.41 mmHg Standard Deviation 12.74	0.07 mmHg Standard Deviation 12.84	-0.43 mmHg Standard Deviation 10.93
Change From Baseline in BP Values (mmHg) Month 2: diastolic BP	0.13 mmHg Standard Deviation 8.56	1.18 mmHg Standard Deviation 8.86	-1.63 mmHg Standard Deviation 8.07
Change From Baseline in BP Values (mmHg) Month 3: systolic BP	0.91 mmHg Standard Deviation 13.84	-0.25 mmHg Standard Deviation 12.71	-0.48 mmHg Standard Deviation 11.64
Change From Baseline in BP Values (mmHg) Month 3: diastolic BP	0.16 mmHg Standard Deviation 8.70	0.70 mmHg Standard Deviation 8.37	-1.31 mmHg Standard Deviation 8.08
Change From Baseline in BP Values (mmHg) Month 6: systolic BP	0.34 mmHg Standard Deviation 12.60	0.36 mmHg Standard Deviation 12.15	-0.97 mmHg Standard Deviation 10.45
Change From Baseline in BP Values (mmHg) Month 6: diastolic BP	-0.04 mmHg Standard Deviation 8.29	0.87 mmHg Standard Deviation 8.34	-1.41 mmHg Standard Deviation 7.95
Change From Baseline in BP Values (mmHg) Month 9: systolic BP	0.35 mmHg Standard Deviation 12.33	-0.43 mmHg Standard Deviation 12.52	-1.69 mmHg Standard Deviation 10.79
Change From Baseline in BP Values (mmHg) Month 9: diastolic BP	0.14 mmHg Standard Deviation 9.12	0.04 mmHg Standard Deviation 8.47	-1.79 mmHg Standard Deviation 8.42
Change From Baseline in BP Values (mmHg) Month 12: systolic BP	2.32 mmHg Standard Deviation 12.94	-0.02 mmHg Standard Deviation 13.17	-1.36 mmHg Standard Deviation 11.19
Change From Baseline in BP Values (mmHg) Month 12: diastolic BP	0.29 mmHg Standard Deviation 9.00	0.37 mmHg Standard Deviation 8.03	-1.41 mmHg Standard Deviation 7.25
Change From Baseline in BP Values (mmHg) Month 15: systolic BP	0.93 mmHg Standard Deviation 12.90	-0.00 mmHg Standard Deviation 13.57	-0.16 mmHg Standard Deviation 12.14
Change From Baseline in BP Values (mmHg) Month 15: diastolic BP	-0.11 mmHg Standard Deviation 8.98	0.41 mmHg Standard Deviation 8.38	-1.63 mmHg Standard Deviation 8.78
Change From Baseline in BP Values (mmHg) Month 18: systolic BP	1.09 mmHg Standard Deviation 12.61	0.23 mmHg Standard Deviation 12.45	-2.38 mmHg Standard Deviation 13.23
Change From Baseline in BP Values (mmHg) Month 18: diastolic BP	-0.30 mmHg Standard Deviation 8.42	0.59 mmHg Standard Deviation 9.09	-1.49 mmHg Standard Deviation 8.82
Change From Baseline in BP Values (mmHg) Month 21: systolic BP	0.49 mmHg Standard Deviation 13.08	0.31 mmHg Standard Deviation 13.68	-0.68 mmHg Standard Deviation 11.18
Change From Baseline in BP Values (mmHg) Month 21: diastolic BP	-0.71 mmHg Standard Deviation 8.94	0.65 mmHg Standard Deviation 9.14	-1.63 mmHg Standard Deviation 8.06
Change From Baseline in BP Values (mmHg) Month 24: systolic BP	1.30 mmHg Standard Deviation 12.73	0.06 mmHg Standard Deviation 13.55	-1.11 mmHg Standard Deviation 12.42
Change From Baseline in BP Values (mmHg) Month 24: diastolic BP	0.38 mmHg Standard Deviation 8.94	0.28 mmHg Standard Deviation 9.62	-1.50 mmHg Standard Deviation 7.75

SECONDARY outcome

Timeframe: Baseline, Months 12 and 24

Population: 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.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=348 Participants 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.	CP-690,550 10 mg BID n=373 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
mTSS Score at Baseline, Months 12 and 24 Baseline	19.05 score on a scale Standard Deviation 38.27	17.89 score on a scale Standard Deviation 38.49	16.11 score on a scale Standard Deviation 29.44
mTSS Score at Baseline, Months 12 and 24 Month 12	19.23 score on a scale Standard Deviation 38.37	18.08 score on a scale Standard Deviation 38.41	17.32 score on a scale Standard Deviation 30.27
mTSS Score at Baseline, Months 12 and 24 Month 24	19.70 score on a scale Standard Deviation 38.69	18.23 score on a scale Standard Deviation 38.43	18.26 score on a scale Standard Deviation 30.99

SECONDARY outcome

Timeframe: Months 12 and 24

Population: 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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=346 Participants 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.	CP-690,550 10 mg BID n=371 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=169 Participants 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.
Change From Baseline in mTSS Score at Months 12 and 24 Month 12	0.37 score on a scale Standard Error 0.14	0.17 score on a scale Standard Error 0.14	1.20 score on a scale Standard Error 0.20
Change From Baseline in mTSS Score at Months 12 and 24 Month 24	0.57 score on a scale Standard Error 0.25	0.28 score on a scale Standard Error 0.24	2.11 score on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: Months 6, 12, and 24

Population: FAS (LEP); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=348 Participants 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.	CP-690,550 10 mg BID n=373 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 Month 6	87.07 percentage of participants	89.25 percentage of participants	73.65 percentage of participants
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 Month 12	82.42 percentage of participants	87.67 percentage of participants	69.01 percentage of participants
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 Month 24	79.89 percentage of participants	83.65 percentage of participants	64.91 percentage of participants

SECONDARY outcome

Timeframe: Months 6, 12, and 24

Population: FAS (LEP)

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=348 Participants 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.	CP-690,550 10 mg BID n=373 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 Month 6	91.67 percentage of participants	93.01 percentage of participants	81.44 percentage of participants
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 Month 12	88.47 percentage of participants	90.88 percentage of participants	74.85 percentage of participants
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 Month 24	85.34 percentage of participants	88.20 percentage of participants	70.18 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, and 24

Population: FAS, imputation using LEP

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=348 Participants 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.	CP-690,550 10 mg BID n=373 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Erosion Scores Baseline	9.05 units on a scale Standard Deviation 19.00	9.06 units on a scale Standard Deviation 19.50	8.38 units on a scale Standard Deviation 15.24
Erosion Scores Month 6	9.18 units on a scale Standard Deviation 19.10	9.15 units on a scale Standard Deviation 19.50	8.78 units on a scale Standard Deviation 15.54
Erosion Scores Month 12	9.05 units on a scale Standard Deviation 18.97	9.18 units on a scale Standard Deviation 19.42	8.97 units on a scale Standard Deviation 15.46
Erosion Scores Month 24	9.21 units on a scale Standard Deviation 18.95	9.22 units on a scale Standard Deviation 19.36	9.37 units on a scale Standard Deviation 15.67

SECONDARY outcome

Timeframe: Baseline, Months 6, 12, and 24

Population: FAS, imputation using LEP

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=348 Participants 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.	CP-690,550 10 mg BID n=373 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
JSN Scores Month 6	10.09 score on a scale Standard Deviation 20.62	8.86 score on a scale Standard Deviation 19.79	8.17 score on a scale Standard Deviation 15.70
JSN Scores Baseline	10.01 score on a scale Standard Deviation 20.58	8.82 score on a scale Standard Deviation 19.80	7.72 score on a scale Standard Deviation 15.28
JSN Scores Month 12	10.18 score on a scale Standard Deviation 20.74	8.90 score on a scale Standard Deviation 19.77	8.35 score on a scale Standard Deviation 16.01
JSN Scores Month 24	10.50 score on a scale Standard Deviation 21.12	9.01 score on a scale Standard Deviation 19.87	8.89 score on a scale Standard Deviation 16.76

SECONDARY outcome

Timeframe: Months 6, 12, and 24

Population: FAS, imputation using LEP

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=348 Participants 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.	CP-690,550 10 mg BID n=373 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Change From Baseline in Erosion Scores Month 6	0.14 units on a scale Standard Error 0.04	0.10 units on a scale Standard Error 0.04	0.35 units on a scale Standard Error 0.06
Change From Baseline in Erosion Scores Month 12	0.13 units on a scale Standard Error 0.07	0.12 units on a scale Standard Error 0.06	0.58 units on a scale Standard Error 0.09
Change From Baseline in Erosion Scores Month 24	0.16 units on a scale Standard Error 0.11	0.16 units on a scale Standard Error 0.10	0.98 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Months 6, 12, and 24

Population: FAS, imputation using LEP

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=348 Participants 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.	CP-690,550 10 mg BID n=373 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Change From Baseline in JSN Scores Month 6	0.06 units on a scale Standard Error 0.06	0.05 units on a scale Standard Error 0.06	0.29 units on a scale Standard Error 0.09
Change From Baseline in JSN Scores Month 12	0.23 units on a scale Standard Error 0.10	0.05 units on a scale Standard Error 0.10	0.60 units on a scale Standard Error 0.14
Change From Baseline in JSN Scores Month 24	0.39 units on a scale Standard Error 0.18	0.12 units on a scale Standard Error 0.17	1.10 units on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: Months 1, 2, 3, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI)

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=366 Participants 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.	CP-690,550 10 mg BID n=391 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=182 Participants 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.
Percentage of Participants Achieving an ACR70 Response Month 1	5.22 percentage of participants	9.23 percentage of participants	0.55 percentage of participants
Percentage of Participants Achieving an ACR70 Response Month 2	16.16 percentage of participants	23.02 percentage of participants	3.30 percentage of participants
Percentage of Participants Achieving an ACR70 Response Month 3	19.95 percentage of participants	26.60 percentage of participants	5.49 percentage of participants
Percentage of Participants Achieving an ACR70 Response Month 9	29.23 percentage of participants	37.85 percentage of participants	13.19 percentage of participants
Percentage of Participants Achieving an ACR70 Response Month 12	28.69 percentage of participants	37.85 percentage of participants	15.38 percentage of participants
Percentage of Participants Achieving an ACR70 Response Month 15	30.05 percentage of participants	37.85 percentage of participants	17.03 percentage of participants
Percentage of Participants Achieving an ACR70 Response Month 18	32.24 percentage of participants	36.57 percentage of participants	15.93 percentage of participants
Percentage of Participants Achieving an ACR70 Response Month 21	32.24 percentage of participants	36.83 percentage of participants	17.58 percentage of participants
Percentage of Participants Achieving an ACR70 Response Month 24	34.15 percentage of participants	37.60 percentage of participants	15.38 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI)

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=369 Participants 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.	CP-690,550 10 mg BID n=394 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants Achieving an ACR20 Response Month 21	65.04 percentage of participants	62.18 percentage of participants	45.11 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 24	64.23 percentage of participants	64.21 percentage of participants	42.39 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 1	49.32 percentage of participants	58.27 percentage of participants	21.20 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 2	63.59 percentage of participants	71.57 percentage of participants	42.39 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 3	69.92 percentage of participants	77.92 percentage of participants	51.63 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 6	71.27 percentage of participants	76.14 percentage of participants	50.54 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 9	72.09 percentage of participants	73.60 percentage of participants	55.43 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 12	67.75 percentage of participants	71.57 percentage of participants	51.09 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 15	68.83 percentage of participants	66.24 percentage of participants	47.28 percentage of participants
Percentage of Participants Achieving an ACR20 Response Month 18	64.23 percentage of participants	65.99 percentage of participants	46.74 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI)

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=369 Participants 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.	CP-690,550 10 mg BID n=394 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants Achieving an ACR50 Response Month 1	17.98 percentage of participants	27.99 percentage of participants	3.80 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 2	32.61 percentage of participants	40.10 percentage of participants	11.41 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 3	40.11 percentage of participants	50.00 percentage of participants	20.11 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 6	46.61 percentage of participants	56.35 percentage of participants	26.63 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 9	49.86 percentage of participants	56.85 percentage of participants	35.33 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 12	49.86 percentage of participants	55.58 percentage of participants	33.70 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 18	47.97 percentage of participants	51.78 percentage of participants	30.43 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 15	50.68 percentage of participants	54.31 percentage of participants	33.15 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 21	49.05 percentage of participants	50.51 percentage of participants	30.43 percentage of participants
Percentage of Participants Achieving an ACR50 Response Month 24	49.32 percentage of participants	49.24 percentage of participants	28.26 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Tender Joints Count (TJC) Baseline	25.65 tender joints Standard Deviation 13.81	25.12 tender joints Standard Deviation 13.51	25.41 tender joints Standard Deviation 15.03
Tender Joints Count (TJC) Month 1	15.75 tender joints Standard Deviation 12.98	13.66 tender joints Standard Deviation 12.61	20.07 tender joints Standard Deviation 14.83
Tender Joints Count (TJC) Month 2	12.12 tender joints Standard Deviation 12.31	10.67 tender joints Standard Deviation 12.31	16.39 tender joints Standard Deviation 14.16
Tender Joints Count (TJC) Month 3	10.03 tender joints Standard Deviation 11.52	8.61 tender joints Standard Deviation 10.67	14.05 tender joints Standard Deviation 14.13
Tender Joints Count (TJC) Month 6	8.71 tender joints Standard Deviation 11.04	6.59 tender joints Standard Deviation 10.28	11.99 tender joints Standard Deviation 13.34
Tender Joints Count (TJC) Month 9	7.31 tender joints Standard Deviation 10.45	6.14 tender joints Standard Deviation 10.11	8.82 tender joints Standard Deviation 11.27
Tender Joints Count (TJC) Month 12	6.60 tender joints Standard Deviation 9.78	5.46 tender joints Standard Deviation 10.16	9.13 tender joints Standard Deviation 12.67
Tender Joints Count (TJC) Month 15	5.55 tender joints Standard Deviation 9.15	5.17 tender joints Standard Deviation 9.79	8.23 tender joints Standard Deviation 10.50
Tender Joints Count (TJC) Month 18	5.12 tender joints Standard Deviation 7.15	4.46 tender joints Standard Deviation 7.98	6.97 tender joints Standard Deviation 8.74
Tender Joints Count (TJC) Month 21	4.60 tender joints Standard Deviation 6.87	4.19 tender joints Standard Deviation 6.40	7.07 tender joints Standard Deviation 9.68
Tender Joints Count (TJC) Month 24	4.50 tender joints Standard Deviation 6.75	4.66 tender joints Standard Deviation 8.52	6.01 tender joints Standard Deviation 6.81

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=367 Participants 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.	CP-690,550 10 mg BID n=393 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Change From Baseline in TJC Month 1	-9.43 tender joints Standard Error 0.54	-11.40 tender joints Standard Error 0.52	-5.11 tender joints Standard Error 0.75
Change From Baseline in TJC Month 2	-12.95 tender joints Standard Error 0.54	-14.33 tender joints Standard Error 0.52	-8.63 tender joints Standard Error 0.76
Change From Baseline in TJC Month 3	-14.95 tender joints Standard Error 0.55	-16.34 tender joints Standard Error 0.52	-10.69 tender joints Standard Error 0.77
Change From Baseline in TJC Month 6	-16.00 tender joints Standard Error 0.55	-18.09 tender joints Standard Error 0.53	-12.38 tender joints Standard Error 0.79
Change From Baseline in TJC Month 9	-17.16 tender joints Standard Error 0.56	-18.29 tender joints Standard Error 0.54	-15.39 tender joints Standard Error 0.81
Change From Baseline in TJC Month 12	-17.85 tender joints Standard Error 0.56	-18.44 tender joints Standard Error 0.54	-14.74 tender joints Standard Error 0.82
Change From Baseline in TJC Month 15	-18.86 tender joints Standard Error 0.58	-18.57 tender joints Standard Error 0.55	-15.70 tender joints Standard Error 0.83
Change From Baseline in TJC Month 18	-19.08 tender joints Standard Error 0.58	-19.41 tender joints Standard Error 0.56	-16.41 tender joints Standard Error 0.86
Change From Baseline in TJC Month 21	-19.54 tender joints Standard Error 0.59	-19.70 tender joints Standard Error 0.57	-16.24 tender joints Standard Error 0.87
Change From Baseline in TJC Month 24	-19.64 tender joints Standard Error 0.59	-19.23 tender joints Standard Error 0.57	-17.01 tender joints Standard Error 0.89

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Swollen Joints Count (SJC) Baseline	16.27 swollen joints Standard Deviation 9.24	15.58 swollen joints Standard Deviation 8.37	16.76 swollen joints Standard Deviation 10.27
Swollen Joints Count (SJC) Month 1	9.90 swollen joints Standard Deviation 9.60	8.02 swollen joints Standard Deviation 7.03	12.56 swollen joints Standard Deviation 9.40
Swollen Joints Count (SJC) Month 2	6.84 swollen joints Standard Deviation 7.74	5.69 swollen joints Standard Deviation 6.29	9.97 swollen joints Standard Deviation 9.05
Swollen Joints Count (SJC) Month 3	5.81 swollen joints Standard Deviation 8.76	4.32 swollen joints Standard Deviation 5.53	7.88 swollen joints Standard Deviation 7.98
Swollen Joints Count (SJC) Month 6	4.70 swollen joints Standard Deviation 7.40	3.69 swollen joints Standard Deviation 6.05	6.30 swollen joints Standard Deviation 7.12
Swollen Joints Count (SJC) Month 9	3.83 swollen joints Standard Deviation 5.67	3.22 swollen joints Standard Deviation 5.93	4.83 swollen joints Standard Deviation 6.74
Swollen Joints Count (SJC) Month 12	3.30 swollen joints Standard Deviation 6.12	2.88 swollen joints Standard Deviation 6.77	5.17 swollen joints Standard Deviation 9.44
Swollen Joints Count (SJC) Month 15	2.63 swollen joints Standard Deviation 6.35	3.00 swollen joints Standard Deviation 7.95	4.92 swollen joints Standard Deviation 8.21
Swollen Joints Count (SJC) Month 18	2.44 swollen joints Standard Deviation 4.07	2.25 swollen joints Standard Deviation 5.28	3.91 swollen joints Standard Deviation 4.85
Swollen Joints Count (SJC) Month 21	2.28 swollen joints Standard Deviation 4.12	2.02 swollen joints Standard Deviation 4.00	3.47 swollen joints Standard Deviation 4.14
Swollen Joints Count (SJC) Month 24	2.00 swollen joints Standard Deviation 3.70	2.29 swollen joints Standard Deviation 6.44	3.38 swollen joints Standard Deviation 4.26

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=367 Participants 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.	CP-690,550 10 mg BID n=393 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Change From Baseline in SJC Month 1	-5.99 swollen joints Standard Error 0.36	-7.75 swollen joints Standard Error 0.35	-3.55 swollen joints Standard Error 0.51
Change From Baseline in SJC Month 2	-8.95 swollen joints Standard Error 0.37	-10.03 swollen joints Standard Error 0.35	-5.98 swollen joints Standard Error 0.51
Change From Baseline in SJC Month 3	-9.97 swollen joints Standard Error 0.37	-11.42 swollen joints Standard Error 0.35	-7.97 swollen joints Standard Error 0.52
Change From Baseline in SJC Month 6	-10.89 swollen joints Standard Error 0.37	-11.97 swollen joints Standard Error 0.36	-9.35 swollen joints Standard Error 0.53
Change From Baseline in SJC Month 9	-11.47 swollen joints Standard Error 0.38	-12.39 swollen joints Standard Error 0.36	-11.00 swollen joints Standard Error 0.55
Change From Baseline in SJC Month 12	-11.97 swollen joints Standard Error 0.38	-12.54 swollen joints Standard Error 0.37	-10.48 swollen joints Standard Error 0.56
Change From Baseline in SJC Month 15	-12.55 swollen joints Standard Error 0.39	-12.30 swollen joints Standard Error 0.38	-10.69 swollen joints Standard Error 0.57
Change From Baseline in SJC Month 18	-12.63 swollen joints Standard Error 0.39	-13.10 swollen joints Standard Error 0.38	-11.31 swollen joints Standard Error 0.59
Change From Baseline in SJC Month 21	-12.74 swollen joints Standard Error 0.40	-13.28 swollen joints Standard Error 0.38	-11.89 swollen joints Standard Error 0.60
Change From Baseline in SJC Month 24	-12.99 swollen joints Standard Error 0.40	-13.06 swollen joints Standard Error 0.39	-11.96 swollen joints Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Patient Assessment of Arthritis Pain Baseline	59.06 mm Standard Deviation 23.87	61.37 mm Standard Deviation 23.14	58.77 mm Standard Deviation 23.58
Patient Assessment of Arthritis Pain Month 1	36.62 mm Standard Deviation 23.72	32.78 mm Standard Deviation 23.31	46.34 mm Standard Deviation 24.47
Patient Assessment of Arthritis Pain Month 2	31.97 mm Standard Deviation 22.94	30.33 mm Standard Deviation 23.66	39.74 mm Standard Deviation 23.72
Patient Assessment of Arthritis Pain Month 3	29.41 mm Standard Deviation 21.53	27.07 mm Standard Deviation 21.54	36.83 mm Standard Deviation 21.99
Patient Assessment of Arthritis Pain Month 6	27.07 mm Standard Deviation 21.21	24.22 mm Standard Deviation 21.53	30.94 mm Standard Deviation 22.87
Patient Assessment of Arthritis Pain Month 9	26.11 mm Standard Deviation 20.35	23.76 mm Standard Deviation 21.24	31.22 mm Standard Deviation 22.50
Patient Assessment of Arthritis Pain Month 12	26.09 mm Standard Deviation 21.29	22.64 mm Standard Deviation 20.15	29.91 mm Standard Deviation 20.76
Patient Assessment of Arthritis Pain Month 15	24.25 mm Standard Deviation 20.39	23.72 mm Standard Deviation 21.97	29.85 mm Standard Deviation 22.94
Patient Assessment of Arthritis Pain Month 18	23.66 mm Standard Deviation 19.29	22.72 mm Standard Deviation 21.78	27.81 mm Standard Deviation 20.66
Patient Assessment of Arthritis Pain Month 21	23.30 mm Standard Deviation 19.86	22.85 mm Standard Deviation 21.79	29.18 mm Standard Deviation 21.46
Patient Assessment of Arthritis Pain Month 24	23.03 mm Standard Deviation 19.80	21.09 mm Standard Deviation 19.32	27.52 mm Standard Deviation 20.28

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=365 Participants 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.	CP-690,550 10 mg BID n=392 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=183 Participants 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.
Change From Baseline in Patient Assessment of Arthritis Pain Month 1	-22.98 mm Standard Error 1.17	-27.26 mm Standard Error 1.12	-13.43 mm Standard Error 1.62
Change From Baseline in Patient Assessment of Arthritis Pain Month 2	-27.73 mm Standard Error 1.17	-29.71 mm Standard Error 1.12	-19.90 mm Standard Error 1.64
Change From Baseline in Patient Assessment of Arthritis Pain Month 3	-29.97 mm Standard Error 1.18	-32.90 mm Standard Error 1.13	-22.22 mm Standard Error 1.66
Change From Baseline in Patient Assessment of Arthritis Pain Month 6	-31.94 mm Standard Error 1.19	-35.35 mm Standard Error 1.15	-27.71 mm Standard Error 1.70
Change From Baseline in Patient Assessment of Arthritis Pain Month 9	-32.34 mm Standard Error 1.21	-35.26 mm Standard Error 1.16	-27.09 mm Standard Error 1.75
Change From Baseline in Patient Assessment of Arthritis Pain Month 12	-32.31 mm Standard Error 1.22	-35.85 mm Standard Error 1.18	-27.76 mm Standard Error 1.79
Change From Baseline in Patient Assessment of Arthritis Pain Month 15	-33.71 mm Standard Error 1.25	-34.54 mm Standard Error 1.20	-28.10 mm Standard Error 1.82
Change From Baseline in Patient Assessment of Arthritis Pain Month 18	-34.26 mm Standard Error 1.26	-35.73 mm Standard Error 1.22	-29.42 mm Standard Error 1.87
Change From Baseline in Patient Assessment of Arthritis Pain Month 21	-34.57 mm Standard Error 1.27	-35.66 mm Standard Error 1.23	-27.87 mm Standard Error 1.90
Change From Baseline in Patient Assessment of Arthritis Pain Month 24	-34.78 mm Standard Error 1.28	-37.57 mm Standard Error 1.24	-29.51 mm Standard Error 1.93

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=369 Participants 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.	CP-690,550 10 mg BID n=394 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=185 Participants 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.
Physician Global Assessment of Arthritis Baseline	61.97 mm Standard Deviation 16.45	60.50 mm Standard Deviation 16.93	59.25 mm Standard Deviation 17.70
Physician Global Assessment of Arthritis Month 1	36.70 mm Standard Deviation 19.24	33.05 mm Standard Deviation 18.32	45.52 mm Standard Deviation 19.73
Physician Global Assessment of Arthritis Month 2	27.84 mm Standard Deviation 18.26	25.80 mm Standard Deviation 17.62	37.19 mm Standard Deviation 18.61
Physician Global Assessment of Arthritis Month 3	25.06 mm Standard Deviation 17.10	22.80 mm Standard Deviation 16.36	32.07 mm Standard Deviation 17.28
Physician Global Assessment of Arthritis Month 6	22.19 mm Standard Deviation 17.31	18.32 mm Standard Deviation 14.74	27.25 mm Standard Deviation 16.80
Physician Global Assessment of Arthritis Month 9	18.68 mm Standard Deviation 15.09	16.61 mm Standard Deviation 15.01	23.65 mm Standard Deviation 16.55
Physician Global Assessment of Arthritis Month 12	17.63 mm Standard Deviation 15.09	14.19 mm Standard Deviation 12.63	22.22 mm Standard Deviation 15.30
Physician Global Assessment of Arthritis Month 15	16.65 mm Standard Deviation 14.03	14.97 mm Standard Deviation 13.13	23.29 mm Standard Deviation 17.36
Physician Global Assessment of Arthritis Month 18	16.47 mm Standard Deviation 12.70	14.02 mm Standard Deviation 12.51	20.19 mm Standard Deviation 14.74
Physician Global Assessment of Arthritis Month 21	15.73 mm Standard Deviation 12.73	14.61 mm Standard Deviation 13.39	20.01 mm Standard Deviation 14.02
Physician Global Assessment of Arthritis Month 24	15.31 mm Standard Deviation 14.14	14.42 mm Standard Deviation 13.63	20.04 mm Standard Deviation 15.54

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=362 Participants 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.	CP-690,550 10 mg BID n=390 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=183 Participants 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.
Change From Baseline in Physician Global Assessment of Arthritis Month 1	-24.89 mm Standard Error 0.86	-28.32 mm Standard Error 0.82	-15.79 mm Standard Error 1.19
Change From Baseline in Physician Global Assessment of Arthritis Month 2	-33.92 mm Standard Error 0.86	-35.49 mm Standard Error 0.82	-24.17 mm Standard Error 1.20
Change From Baseline in Physician Global Assessment of Arthritis Month 3	-36.41 mm Standard Error 0.87	-38.48 mm Standard Error 0.83	-28.62 mm Standard Error 1.22
Change From Baseline in Physician Global Assessment of Arthritis Month 6	-39.04 mm Standard Error 0.88	-42.49 mm Standard Error 0.84	-33.41 mm Standard Error 1.25
Change From Baseline in Physician Global Assessment of Arthritis Month 9	-42.09 mm Standard Error 0.89	-43.94 mm Standard Error 0.85	-36.54 mm Standard Error 1.29
Change From Baseline in Physician Global Assessment of Arthritis Month 12	-43.07 mm Standard Error 0.90	-46.02 mm Standard Error 0.87	-37.43 mm Standard Error 1.32
Change From Baseline in Physician Global Assessment of Arthritis Month 15	-43.91 mm Standard Error 0.92	-45.40 mm Standard Error 0.88	-36.17 mm Standard Error 1.34
Change From Baseline in Physician Global Assessment of Arthritis Month 18	-44.00 mm Standard Error 0.93	-46.50 mm Standard Error 0.90	-38.65 mm Standard Error 1.38
Change From Baseline in Physician Global Assessment of Arthritis Month 21	-44.76 mm Standard Error 0.94	-46.02 mm Standard Error 0.90	-38.92 mm Standard Error 1.40
Change From Baseline in Physician Global Assessment of Arthritis Month 24	-45.07 mm Standard Error 0.95	-46.30 mm Standard Error 0.91	-38.93 mm Standard Error 1.42

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Patient Global Assessment of Arthritis Baseline	60.20 mm Standard Deviation 24.56	60.88 mm Standard Deviation 22.65	57.71 mm Standard Deviation 24.30
Patient Global Assessment of Arthritis Month 1	38.27 mm Standard Deviation 24.83	32.63 mm Standard Deviation 23.09	46.15 mm Standard Deviation 22.82
Patient Global Assessment of Arthritis Month 2	31.91 mm Standard Deviation 22.90	28.94 mm Standard Deviation 22.63	41.29 mm Standard Deviation 22.73
Patient Global Assessment of Arthritis Month 3	30.36 mm Standard Deviation 21.78	28.60 mm Standard Deviation 22.21	37.43 mm Standard Deviation 21.20
Patient Global Assessment of Arthritis Month 6	28.37 mm Standard Deviation 21.23	24.84 mm Standard Deviation 21.61	32.12 mm Standard Deviation 21.92
Patient Global Assessment of Arthritis Month 9	26.73 mm Standard Deviation 20.38	24.98 mm Standard Deviation 22.30	32.79 mm Standard Deviation 22.42
Patient Global Assessment of Arthritis Month 12	26.72 mm Standard Deviation 20.84	24.38 mm Standard Deviation 22.34	32.40 mm Standard Deviation 21.69
Patient Global Assessment of Arthritis Month 15	25.19 mm Standard Deviation 20.12	23.79 mm Standard Deviation 21.96	32.26 mm Standard Deviation 22.79
Patient Global Assessment of Arthritis Month 18	24.76 mm Standard Deviation 19.93	24.38 mm Standard Deviation 22.59	29.31 mm Standard Deviation 20.91
Patient Global Assessment of Arthritis Month 21	24.72 mm Standard Deviation 20.93	23.86 mm Standard Deviation 21.52	30.19 mm Standard Deviation 21.15
Patient Global Assessment of Arthritis Month 24	24.42 mm Standard Deviation 21.43	23.61 mm Standard Deviation 20.86	28.81 mm Standard Deviation 20.54

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=365 Participants 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.	CP-690,550 10 mg BID n=392 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=183 Participants 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.
Change From Baseline in Patient Global Assessment of Arthritis Month 1	-22.22 mm Standard Error 1.17	-27.87 mm Standard Error 1.12	-14.12 mm Standard Error 1.62
Change From Baseline in Patient Global Assessment of Arthritis Month 2	-28.74 mm Standard Error 1.17	-31.54 mm Standard Error 1.12	-18.86 mm Standard Error 1.64
Change From Baseline in Patient Global Assessment of Arthritis Month 3	-30.03 mm Standard Error 1.18	-31.72 mm Standard Error 1.13	-22.18 mm Standard Error 1.66
Change From Baseline in Patient Global Assessment of Arthritis Month 6	-31.65 mm Standard Error 1.19	-35.11 mm Standard Error 1.15	-27.00 mm Standard Error 1.70
Change From Baseline in Patient Global Assessment of Arthritis Month 9	-32.70 mm Standard Error 1.21	-34.48 mm Standard Error 1.16	-26.15 mm Standard Error 1.76
Change From Baseline in Patient Global Assessment of Arthritis Month 12	-32.75 mm Standard Error 1.22	-34.62 mm Standard Error 1.18	-26.07 mm Standard Error 1.79
Change From Baseline in Patient Global Assessment of Arthritis Month 15	-33.82 mm Standard Error 1.25	-34.94 mm Standard Error 1.20	-26.70 mm Standard Error 1.82
Change From Baseline in Patient Global Assessment of Arthritis Month 18	-34.18 mm Standard Error 1.26	-34.65 mm Standard Error 1.22	-28.64 mm Standard Error 1.87
Change From Baseline in Patient Global Assessment of Arthritis Month 21	-34.18 mm Standard Error 1.27	-35.26 mm Standard Error 1.23	-27.56 mm Standard Error 1.90
Change From Baseline in Patient Global Assessment of Arthritis Month 24	-34.41 mm Standard Error 1.29	-35.74 mm Standard Error 1.24	-28.81 mm Standard Error 1.93

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

CRP measured in milligrams per liter (mg/L)

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
C-Reactive Protein Baseline	22.68 mg/L Standard Deviation 27.09	20.25 mg/L Standard Deviation 23.92	25.92 mg/L Standard Deviation 30.94
C-Reactive Protein Month 1	6.62 mg/L Standard Deviation 9.68	3.23 mg/L Standard Deviation 5.35	17.37 mg/L Standard Deviation 24.26
C-Reactive Protein Month 2	6.47 mg/L Standard Deviation 15.24	3.48 mg/L Standard Deviation 9.38	16.12 mg/L Standard Deviation 26.55
C-Reactive Protein Month 3	6.75 mg/L Standard Deviation 12.81	3.05 mg/L Standard Deviation 5.60	11.90 mg/L Standard Deviation 17.11
C-Reactive Protein Month 6	5.22 mg/L Standard Deviation 11.56	3.14 mg/L Standard Deviation 5.51	12.21 mg/L Standard Deviation 19.32
C-Reactive Protein Month 9	6.01 mg/L Standard Deviation 12.89	3.39 mg/L Standard Deviation 6.32	8.18 mg/L Standard Deviation 12.36
C-Reactive Protein Month 12	5.26 mg/L Standard Deviation 9.93	2.72 mg/L Standard Deviation 4.46	9.64 mg/L Standard Deviation 16.36
C-Reactive Protein Month 15	5.57 mg/L Standard Deviation 15.52	2.96 mg/L Standard Deviation 4.40	8.61 mg/L Standard Deviation 13.02
C-Reactive Protein Month 18	4.57 mg/L Standard Deviation 8.71	3.59 mg/L Standard Deviation 11.42	8.98 mg/L Standard Deviation 11.72
C-Reactive Protein Month 21	4.89 mg/L Standard Deviation 7.58	4.07 mg/L Standard Deviation 8.12	9.54 mg/L Standard Deviation 13.72
C-Reactive Protein Month 24	5.57 mg/L Standard Deviation 11.49	3.71 mg/L Standard Deviation 7.00	10.07 mg/L Standard Deviation 17.04

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS

Change from Baseline in CRP measured in mg/L.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=366 Participants 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.	CP-690,550 10 mg BID n=390 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Change From Baseline in CRP Month 24	-15.97 mg/L Standard Error 0.75	-17.96 mg/L Standard Error 0.73	-10.31 mg/L Standard Error 1.14
Change From Baseline in CRP Month 1	-15.64 mg/L Standard Error 0.68	-18.84 mg/L Standard Error 0.66	-5.55 mg/L Standard Error 0.95
Change From Baseline in CRP Month 2	-16.02 mg/L Standard Error 0.69	-18.59 mg/L Standard Error 0.66	-6.83 mg/L Standard Error 0.97
Change From Baseline in CRP Month 3	-15.69 mg/L Standard Error 0.69	-19.01 mg/L Standard Error 0.66	-9.86 mg/L Standard Error 0.97
Change From Baseline in CRP Month 6	-16.98 mg/L Standard Error 0.70	-18.76 mg/L Standard Error 0.67	-9.68 mg/L Standard Error 1.00
Change From Baseline in CRP Month 9	-16.03 mg/L Standard Error 0.71	-18.48 mg/L Standard Error 0.68	-12.75 mg/L Standard Error 1.03
Change From Baseline in CRP Month 12	-16.58 mg/L Standard Error 0.72	-19.16 mg/L Standard Error 0.69	-11.12 mg/L Standard Error 1.05
Change From Baseline in CRP Month 15	-16.10 mg/L Standard Error 0.73	-18.80 mg/L Standard Error 0.70	-12.35 mg/L Standard Error 1.07
Change From Baseline in CRP Month 18	-17.06 mg/L Standard Error 0.74	-18.17 mg/L Standard Error 0.72	-11.62 mg/L Standard Error 1.10
Change From Baseline in CRP Month 21	-16.83 mg/L Standard Error 0.75	-17.67 mg/L Standard Error 0.72	-11.07 mg/L Standard Error 1.11

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Baseline	5.56 units on a scale Standard Deviation 0.91	5.46 units on a scale Standard Deviation 0.94	5.62 units on a scale Standard Deviation 0.95
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 1	4.21 units on a scale Standard Deviation 1.08	3.77 units on a scale Standard Deviation 1.09	4.96 units on a scale Standard Deviation 1.17
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 2	3.67 units on a scale Standard Deviation 1.21	3.31 units on a scale Standard Deviation 1.18	4.50 units on a scale Standard Deviation 1.19
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 3	3.41 units on a scale Standard Deviation 1.21	3.05 units on a scale Standard Deviation 1.12	4.14 units on a scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 6	3.21 units on a scale Standard Deviation 1.25	2.76 units on a scale Standard Deviation 1.08	3.85 units on a scale Standard Deviation 1.34
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 9	3.05 units on a scale Standard Deviation 1.22	2.69 units on a scale Standard Deviation 1.15	3.49 units on a scale Standard Deviation 1.20
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 12	2.92 units on a scale Standard Deviation 1.18	2.52 units on a scale Standard Deviation 1.07	3.42 units on a scale Standard Deviation 1.30
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 15	2.78 units on a scale Standard Deviation 1.10	2.50 units on a scale Standard Deviation 1.12	3.38 units on a scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 18	2.70 units on a scale Standard Deviation 1.06	2.47 units on a scale Standard Deviation 0.98	3.32 units on a scale Standard Deviation 1.17
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 21	2.67 units on a scale Standard Deviation 1.10	2.48 units on a scale Standard Deviation 1.07	3.33 units on a scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Month 24	2.65 units on a scale Standard Deviation 1.08	2.44 units on a scale Standard Deviation 1.03	3.22 units on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=372 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Baseline	6.62 units on a scale Standard Deviation 0.98	6.54 units on a scale Standard Deviation 0.96	6.60 units on a scale Standard Deviation 1.02
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 1	5.18 units on a scale Standard Deviation 1.28	4.70 units on a scale Standard Deviation 1.32	5.84 units on a scale Standard Deviation 1.24
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 2	4.54 units on a scale Standard Deviation 1.45	4.17 units on a scale Standard Deviation 1.39	5.35 units on a scale Standard Deviation 1.24
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 3	4.21 units on a scale Standard Deviation 1.45	3.94 units on a scale Standard Deviation 1.31	4.98 units on a scale Standard Deviation 1.37
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 6	4.05 units on a scale Standard Deviation 1.44	3.62 units on a scale Standard Deviation 1.31	4.61 units on a scale Standard Deviation 1.48
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 9	3.84 units on a scale Standard Deviation 1.37	3.53 units on a scale Standard Deviation 1.36	4.27 units on a scale Standard Deviation 1.36
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 12	3.69 units on a scale Standard Deviation 1.33	3.37 units on a scale Standard Deviation 1.29	4.23 units on a scale Standard Deviation 1.38
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 15	3.59 units on a scale Standard Deviation 1.23	3.32 units on a scale Standard Deviation 1.31	4.17 units on a scale Standard Deviation 1.46
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 18	3.51 units on a scale Standard Deviation 1.22	3.33 units on a scale Standard Deviation 1.18	4.05 units on a scale Standard Deviation 1.37
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 21	3.49 units on a scale Standard Deviation 1.26	3.33 units on a scale Standard Deviation 1.29	4.09 units on a scale Standard Deviation 1.39
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Month 24	3.43 units on a scale Standard Deviation 1.25	3.29 units on a scale Standard Deviation 1.29	3.99 units on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=366 Participants 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.	CP-690,550 10 mg BID n=389 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Change From Baseline in DAS28-3(CRP) Month 1	-1.30 units on a scale Standard Error 0.06	-1.71 units on a scale Standard Error 0.06	-0.58 units on a scale Standard Error 0.08
Change From Baseline in DAS28-3(CRP) Month 2	-1.85 units on a scale Standard Error 0.06	-2.16 units on a scale Standard Error 0.06	-1.02 units on a scale Standard Error 0.08
Change From Baseline in DAS28-3(CRP) Month 3	-2.09 units on a scale Standard Error 0.06	-2.42 units on a scale Standard Error 0.06	-1.36 units on a scale Standard Error 0.08
Change From Baseline in DAS28-3(CRP) Month 6	-2.27 units on a scale Standard Error 0.06	-2.68 units on a scale Standard Error 0.06	-1.62 units on a scale Standard Error 0.09
Change From Baseline in DAS28-3(CRP) Month 9	-2.40 units on a scale Standard Error 0.06	-2.72 units on a scale Standard Error 0.06	-1.95 units on a scale Standard Error 0.09
Change From Baseline in DAS28-3(CRP) Month 12	-2.52 units on a scale Standard Error 0.06	-2.85 units on a scale Standard Error 0.06	-1.99 units on a scale Standard Error 0.09
Change From Baseline in DAS28-3(CRP) Month 15	-2.65 units on a scale Standard Error 0.06	-2.85 units on a scale Standard Error 0.06	-2.03 units on a scale Standard Error 0.09
Change From Baseline in DAS28-3(CRP) Month 18	-2.72 units on a scale Standard Error 0.06	-2.91 units on a scale Standard Error 0.06	-2.05 units on a scale Standard Error 0.10
Change From Baseline in DAS28-3(CRP) Month 21	-2.75 units on a scale Standard Error 0.06	-2.89 units on a scale Standard Error 0.06	-2.05 units on a scale Standard Error 0.10
Change From Baseline in DAS28-3(CRP) Month 24	-2.76 units on a scale Standard Error 0.07	-2.94 units on a scale Standard Error 0.06	-2.12 units on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=338 Participants 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.	CP-690,550 10 mg BID n=369 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=167 Participants 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.
Change From Baseline in DAS28-4(ESR) Month 1	-1.40 units on a scale Standard Error 0.07	-1.83 units on a scale Standard Error 0.07	-0.72 units on a scale Standard Error 0.10
Change From Baseline in DAS28-4(ESR) Month 2	-2.03 units on a scale Standard Error 0.07	-2.36 units on a scale Standard Error 0.07	-1.17 units on a scale Standard Error 0.10
Change From Baseline in DAS28-4(ESR) Month 3	-2.34 units on a scale Standard Error 0.07	-2.59 units on a scale Standard Error 0.07	-1.53 units on a scale Standard Error 0.10
Change From Baseline in DAS28-4(ESR) Month 6	-2.47 units on a scale Standard Error 0.07	-2.88 units on a scale Standard Error 0.07	-1.87 units on a scale Standard Error 0.10
Change From Baseline in DAS28-4(ESR) Month 9	-2.64 units on a scale Standard Error 0.07	-2.93 units on a scale Standard Error 0.07	-2.19 units on a scale Standard Error 0.10
Change From Baseline in DAS28-4(ESR) Month 12	-2.78 units on a scale Standard Error 0.07	-3.05 units on a scale Standard Error 0.07	-2.20 units on a scale Standard Error 0.11
Change From Baseline in DAS28-4(ESR) Month 15	-2.87 units on a scale Standard Error 0.07	-3.08 units on a scale Standard Error 0.07	-2.25 units on a scale Standard Error 0.11
Change From Baseline in DAS28-4(ESR) Month 18	-2.92 units on a scale Standard Error 0.07	-3.09 units on a scale Standard Error 0.07	-2.34 units on a scale Standard Error 0.11
Change From Baseline in DAS28-4(ESR) Month 21	-2.96 units on a scale Standard Error 0.08	-3.10 units on a scale Standard Error 0.07	-2.30 units on a scale Standard Error 0.11
Change From Baseline in DAS28-4(ESR) Month 24	-2.99 units on a scale Standard Error 0.08	-3.16 units on a scale Standard Error 0.07	-2.40 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=367 Participants 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.	CP-690,550 10 mg BID n=394 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 1	16.67 percentage of participants	33.16 percentage of participants	5.98 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 2	35.42 percentage of participants	47.97 percentage of participants	14.13 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 3	40.33 percentage of participants	56.85 percentage of participants	19.57 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 6	47.68 percentage of participants	62.69 percentage of participants	27.72 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 9	52.04 percentage of participants	60.41 percentage of participants	33.15 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 12	52.59 percentage of participants	64.97 percentage of participants	32.61 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 15	53.41 percentage of participants	58.88 percentage of participants	29.89 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 18	52.59 percentage of participants	56.09 percentage of participants	25.00 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 21	52.59 percentage of participants	55.84 percentage of participants	28.26 percentage of participants
Percentage of Participants With DAS28-3(CRP) ≤3.2 Month 24	52.32 percentage of participants	56.85 percentage of participants	29.35 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=342 Participants 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.	CP-690,550 10 mg BID n=372 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 1	7.40 percentage of participants	14.09 percentage of participants	2.99 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 2	18.42 percentage of participants	25.81 percentage of participants	4.71 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 3	25.15 percentage of participants	30.38 percentage of participants	9.94 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 6	27.78 percentage of participants	38.17 percentage of participants	14.04 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 9	29.24 percentage of participants	39.78 percentage of participants	18.13 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 12	33.33 percentage of participants	41.13 percentage of participants	18.71 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 15	33.04 percentage of participants	40.86 percentage of participants	18.13 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 18	32.16 percentage of participants	35.22 percentage of participants	16.37 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 21	34.21 percentage of participants	38.17 percentage of participants	16.37 percentage of participants
Percentage of Participants With DAS28-4(ESR) ≤3.2 Month 24	34.80 percentage of participants	36.02 percentage of participants	15.79 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=367 Participants 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.	CP-690,550 10 mg BID n=394 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants With DAS28-3(CRP) <2.6 Month 1	7.38 percentage of participants	14.14 percentage of participants	2.72 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 2	20.44 percentage of participants	28.68 percentage of participants	5.43 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 3	25.89 percentage of participants	37.82 percentage of participants	9.78 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 6	31.34 percentage of participants	47.21 percentage of participants	15.22 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 9	36.24 percentage of participants	45.69 percentage of participants	17.39 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 12	36.51 percentage of participants	49.49 percentage of participants	20.65 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 15	37.60 percentage of participants	49.24 percentage of participants	19.57 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 18	38.42 percentage of participants	44.67 percentage of participants	19.02 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 21	37.06 percentage of participants	44.67 percentage of participants	17.39 percentage of participants
Percentage of Participants With DAS28-3(CRP) <2.6 Month 24	38.42 percentage of participants	43.91 percentage of participants	18.48 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=342 Participants 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.	CP-690,550 10 mg BID n=372 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Percentage of Participants With DAS28-4(ESR) <2.6 Month 12	18.71 percentage of participants	23.39 percentage of participants	11.70 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 15	16.37 percentage of participants	24.19 percentage of participants	12.87 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 18	16.96 percentage of participants	19.89 percentage of participants	11.11 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 21	18.42 percentage of participants	21.42 percentage of participants	8.77 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 24	20.76 percentage of participants	22.31 percentage of participants	9.94 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 6	14.62 percentage of participants	21.77 percentage of participants	7.60 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 9	16.37 percentage of participants	23.66 percentage of participants	9.94 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 1	2.07 percentage of participants	5.69 percentage of participants	0.00 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 2	9.06 percentage of participants	12.90 percentage of participants	2.35 percentage of participants
Percentage of Participants With DAS28-4(ESR) <2.6 Month 3	13.74 percentage of participants	17.47 percentage of participants	4.68 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=367 Participants 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.	CP-690,550 10 mg BID n=394 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 9	80.38 percentage of participants	82.74 percentage of participants	64.13 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 12	76.29 percentage of participants	78.68 percentage of participants	60.87 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 15	75.20 percentage of participants	73.35 percentage of participants	59.24 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 18	73.02 percentage of participants	71.57 percentage of participants	55.98 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 21	69.48 percentage of participants	69.29 percentage of participants	50.54 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 24	68.94 percentage of participants	69.80 percentage of participants	49.46 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 1	71.86 percentage of participants	80.46 percentage of participants	37.50 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 2	80.11 percentage of participants	85.79 percentage of participants	58.15 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 3	83.65 percentage of participants	89.34 percentage of participants	68.48 percentage of participants
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Month 6	82.83 percentage of participants	85.03 percentage of participants	64.13 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=342 Participants 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.	CP-690,550 10 mg BID n=372 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 1	62.43 percentage of participants	74.25 percentage of participants	33.53 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 2	74.27 percentage of participants	82.26 percentage of participants	50.00 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 3	80.41 percentage of participants	88.17 percentage of participants	66.67 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 6	78.95 percentage of participants	84.14 percentage of participants	60.82 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 9	78.36 percentage of participants	81.72 percentage of participants	61.40 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 12	76.61 percentage of participants	79.57 percentage of participants	59.65 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 15	74.85 percentage of participants	73.12 percentage of participants	56.73 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 18	70.18 percentage of participants	70.97 percentage of participants	52.05 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 21	69.88 percentage of participants	69.89 percentage of participants	48.54 percentage of participants
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Month 24	68.71 percentage of participants	69.62 percentage of participants	49.12 percentage of participants

SECONDARY outcome

Timeframe: Months 6, 9, 12, 15, 18, 21, and 24

Population: FAS, no imputation.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months	28.42 percentage of participants	38.54 percentage of participants	13.98 percentage of participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS, no imputation.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 2 consecutive visits	8.6 percentage of participants	6.5 percentage of participants	7.5 percentage of participants
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 3 consecutive visits	8.6 percentage of participants	11.1 percentage of participants	14.5 percentage of participants
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 4 consecutive visits	5.6 percentage of participants	6.8 percentage of participants	10.2 percentage of participants
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 5 consecutive visits	7.0 percentage of participants	4.3 percentage of participants	5.4 percentage of participants
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 6 consecutive visits	6.7 percentage of participants	6.0 percentage of participants	4.8 percentage of participants
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 7 consecutive visits	6.7 percentage of participants	6.8 percentage of participants	5.9 percentage of participants
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 8 consecutive visits	9.4 percentage of participants	4.5 percentage of participants	5.4 percentage of participants
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 9 consecutive visits	9.7 percentage of participants	11.6 percentage of participants	9.7 percentage of participants
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits 10 consecutive visits	23.6 percentage of participants	30.5 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS, no imputation.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 2 consecutive visits	9.9 percentage of participants	9.8 percentage of participants	9.1 percentage of participants
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 3 consecutive visits	10.7 percentage of participants	9.1 percentage of participants	8.1 percentage of participants
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 4 consecutive visits	6.4 percentage of participants	7.3 percentage of participants	5.4 percentage of participants
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 5 consecutive visits	9.7 percentage of participants	5.3 percentage of participants	3.2 percentage of participants
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 6 consecutive visits	4.6 percentage of participants	4.8 percentage of participants	5.4 percentage of participants
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 7 consecutive visits	6.2 percentage of participants	6.0 percentage of participants	5.9 percentage of participants
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 8 consecutive visits	5.6 percentage of participants	7.1 percentage of participants	2.2 percentage of participants
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 9 consecutive visits	5.6 percentage of participants	8.3 percentage of participants	1.6 percentage of participants
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits 10 consecutive visits	5.9 percentage of participants	11.8 percentage of participants	1.1 percentage of participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS, no imputation.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 2 consecutive visits	10.7 percentage of participants	8.8 percentage of participants	5.9 percentage of participants
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 3 consecutive visits	5.9 percentage of participants	7.8 percentage of participants	3.8 percentage of participants
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 4 consecutive visits	5.4 percentage of participants	6.0 percentage of participants	4.3 percentage of participants
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 5 consecutive visits	4.3 percentage of participants	5.8 percentage of participants	1.6 percentage of participants
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 6 consecutive visits	3.8 percentage of participants	3.3 percentage of participants	1.1 percentage of participants
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 7 consecutive visits	2.9 percentage of participants	4.8 percentage of participants	2.7 percentage of participants
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 8 consecutive visits	2.9 percentage of participants	4.0 percentage of participants	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 1 participant met this category
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 9 consecutive visits	3.2 percentage of participants	5.8 percentage of participants	1.1 percentage of participants
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits 10 consecutive visits	1.3 percentage of participants	2.8 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS, no imputation.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 2 consecutive visits	10.2 percentage of participants	10.6 percentage of participants	7.0 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 3 consecutive visits	8.6 percentage of participants	8.6 percentage of participants	7.0 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 4 consecutive visits	6.4 percentage of participants	7.3 percentage of participants	3.8 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 5 consecutive visits	5.1 percentage of participants	5.5 percentage of participants	4.3 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 6 consecutive visits	5.4 percentage of participants	4.0 percentage of participants	1.1 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 7 consecutive visits	4.0 percentage of participants	7.3 percentage of participants	1.6 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 8 consecutive visits	3.2 percentage of participants	6.5 percentage of participants	1.1 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 9 consecutive visits	4.0 percentage of participants	7.6 percentage of participants	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 1 participant met this category
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits 10 consecutive visits	1.3 percentage of participants	2.8 percentage of participants	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 1 participant met this category

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS, no imputation.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 2 consecutive visits	6.2 percentage of participants	7.6 percentage of participants	4.3 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 3 consecutive visits	5.4 percentage of participants	5.3 percentage of participants	2.7 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 4 consecutive visits	4.0 percentage of participants	4.0 percentage of participants	3.2 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 5 consecutive visits	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 2 participants met this category	1.3 percentage of participants	1.6 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 6 consecutive visits	2.4 percentage of participants	2.0 percentage of participants	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 1 participant met this category
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 7 consecutive visits	1.9 percentage of participants	3.0 percentage of participants	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 1 participant met this category
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 8 consecutive visits	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 2 participants met this category	2.0 percentage of participants	0 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 9 consecutive visits	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 2 participants met this category	2.5 percentage of participants	1.1 percentage of participants
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits 10 consecutive visits	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 2 participants met this category	NA percentage of participants Values less than 1% were grouped and specific values labelled as 'not applicable'. Only 3 participants met this category	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=396 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Health Assessment Questionnaire Disability Index (HAQ-DI) Baseline	1.54 units on a scale Standard Deviation 0.65	1.50 units on a scale Standard Deviation 0.67	1.52 units on a scale Standard Deviation 0.65
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 1	1.05 units on a scale Standard Deviation 0.67	0.89 units on a scale Standard Deviation 0.65	1.30 units on a scale Standard Deviation 0.67
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 2	0.89 units on a scale Standard Deviation 0.67	0.74 units on a scale Standard Deviation 0.62	1.17 units on a scale Standard Deviation 0.66
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 3	0.78 units on a scale Standard Deviation 0.64	0.67 units on a scale Standard Deviation 0.63	1.03 units on a scale Standard Deviation 0.63
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 6	0.69 units on a scale Standard Deviation 0.64	0.57 units on a scale Standard Deviation 0.59	0.92 units on a scale Standard Deviation 0.62
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 9	0.66 units on a scale Standard Deviation 0.62	0.56 units on a scale Standard Deviation 0.58	0.83 units on a scale Standard Deviation 0.57
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 12	0.64 units on a scale Standard Deviation 0.61	0.51 units on a scale Standard Deviation 0.56	0.79 units on a scale Standard Deviation 0.58
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 15	0.59 units on a scale Standard Deviation 0.59	0.51 units on a scale Standard Deviation 0.56	0.83 units on a scale Standard Deviation 0.64
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 18	0.58 units on a scale Standard Deviation 0.58	0.48 units on a scale Standard Deviation 0.55	0.74 units on a scale Standard Deviation 0.60
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 21	0.59 units on a scale Standard Deviation 0.58	0.49 units on a scale Standard Deviation 0.56	0.76 units on a scale Standard Deviation 0.64
Health Assessment Questionnaire Disability Index (HAQ-DI) Month 24	0.58 units on a scale Standard Deviation 0.60	0.48 units on a scale Standard Deviation 0.56	0.77 units on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=365 Participants 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.	CP-690,550 10 mg BID n=391 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Change From Baseline in HAQ-DI Score Month 1	-0.48 units on a scale Standard Error 0.03	-0.62 units on a scale Standard Error 0.03	-0.23 units on a scale Standard Error 0.04
Change From Baseline in HAQ-DI Score Month 2	-0.65 units on a scale Standard Error 0.03	-0.77 units on a scale Standard Error 0.03	-0.35 units on a scale Standard Error 0.4
Change From Baseline in HAQ-DI Score Month 3	-0.75 units on a scale Standard Error 0.03	-0.85 units on a scale Standard Error 0.03	-0.47 units on a scale Standard Error 0.04
Change From Baseline in HAQ-DI Score Month 6	-0.83 units on a scale Standard Error 0.03	-0.94 units on a scale Standard Error 0.03	-0.58 units on a scale Standard Error 0.04
Change From Baseline in HAQ-DI Score Month 9	-0.85 units on a scale Standard Error 0.03	-0.95 units on a scale Standard Error 0.03	-0.65 units on a scale Standard Error 0.04
Change From Baseline in HAQ-DI Score Month 12	-0.87 units on a scale Standard Error 0.03	-0.98 units on a scale Standard Error 0.03	-0.68 units on a scale Standard Error 0.04
Change From Baseline in HAQ-DI Score Month 15	-0.90 units on a scale Standard Error 0.03	-0.98 units on a scale Standard Error 0.03	-0.65 units on a scale Standard Error 0.05
Change From Baseline in HAQ-DI Score Month 18	-0.90 units on a scale Standard Error 0.03	-1.01 units on a scale Standard Error 0.03	-0.74 units on a scale Standard Error 0.05
Change From Baseline in HAQ-DI Score Month 21	-0.90 units on a scale Standard Error 0.03	-1.00 units on a scale Standard Error 0.03	-0.72 units on a scale Standard Error 0.05
Change From Baseline in HAQ-DI Score Month 24	-0.90 units on a scale Standard Error 0.03	-1.01 units on a scale Standard Error 0.03	-0.70 units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=366 Participants 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.	CP-690,550 10 mg BID n=392 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 1	64.38 percentage of participants	73.91 percentage of participants	45.65 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 2	69.13 percentage of participants	79.85 percentage of participants	61.41 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 3	72.95 percentage of participants	80.36 percentage of participants	65.22 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 6	74.32 percentage of participants	77.81 percentage of participants	63.04 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 9	73.50 percentage of participants	73.21 percentage of participants	61.41 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 12	68.03 percentage of participants	71.43 percentage of participants	58.70 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 15	65.30 percentage of participants	67.86 percentage of participants	51.63 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 18	64.21 percentage of participants	64.80 percentage of participants	48.91 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 21	62.30 percentage of participants	65.05 percentage of participants	46.74 percentage of participants
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Month 24	60.11 percentage of participants	65.05 percentage of participants	46.74 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=366 Participants 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.	CP-690,550 10 mg BID n=392 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 1	54.79 percentage of participants	65.73 percentage of participants	32.61 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 2	62.30 percentage of participants	73.21 percentage of participants	47.83 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 3	65.57 percentage of participants	74.23 percentage of participants	54.89 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 6	69.67 percentage of participants	73.21 percentage of participants	53.80 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 9	69.13 percentage of participants	69.39 percentage of participants	53.26 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 12	65.03 percentage of participants	67.35 percentage of participants	52.72 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 15	61.20 percentage of participants	65.31 percentage of participants	47.83 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 18	59.84 percentage of participants	63.27 percentage of participants	46.20 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 21	58.74 percentage of participants	61.22 percentage of participants	44.02 percentage of participants
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Month 24	56.83 percentage of participants	62.76 percentage of participants	43.48 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=366 Participants 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.	CP-690,550 10 mg BID n=392 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 1	47.95 percentage of participants	55.75 percentage of participants	26.09 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 2	55.46 percentage of participants	67.86 percentage of participants	39.67 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 3	60.66 percentage of participants	69.64 percentage of participants	43.48 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 6	63.11 percentage of participants	68.88 percentage of participants	48.91 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 9	65.30 percentage of participants	65.05 percentage of participants	47.28 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 12	59.56 percentage of participants	63.01 percentage of participants	45.65 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 15	58.20 percentage of participants	60.71 percentage of participants	44.57 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 18	56.28 percentage of participants	60.71 percentage of participants	41.30 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 21	55.19 percentage of participants	58.16 percentage of participants	41.85 percentage of participants
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Month 24	53.28 percentage of participants	59.44 percentage of participants	37.50 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=395 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=185 Participants 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.
Short Form 36 (SF-36) Mental Component Score Baseline	40.48 units on a scale Standard Deviation 12.00	40.73 units on a scale Standard Deviation 11.73	40.93 units on a scale Standard Deviation 11.27
Short Form 36 (SF-36) Mental Component Score Month 1	44.90 units on a scale Standard Deviation 11.40	46.70 units on a scale Standard Deviation 10.78	43.98 units on a scale Standard Deviation 10.71
Short Form 36 (SF-36) Mental Component Score Month 2	45.95 units on a scale Standard Deviation 12.10	46.09 units on a scale Standard Deviation 11.28	44.35 units on a scale Standard Deviation 10.48
Short Form 36 (SF-36) Mental Component Score Month 3	46.82 units on a scale Standard Deviation 11.21	46.59 units on a scale Standard Deviation 11.33	45.27 units on a scale Standard Deviation 10.42
Short Form 36 (SF-36) Mental Component Score Month 6	47.08 units on a scale Standard Deviation 10.97	47.55 units on a scale Standard Deviation 10.26	45.73 units on a scale Standard Deviation 12.06
Short Form 36 (SF-36) Mental Component Score Month 9	46.91 units on a scale Standard Deviation 10.74	48.04 units on a scale Standard Deviation 10.42	46.86 units on a scale Standard Deviation 10.85
Short Form 36 (SF-36) Mental Component Score Month 12	47.04 units on a scale Standard Deviation 10.67	48.05 units on a scale Standard Deviation 9.99	45.71 units on a scale Standard Deviation 11.01
Short Form 36 (SF-36) Mental Component Score Month 15	47.40 units on a scale Standard Deviation 10.31	48.04 units on a scale Standard Deviation 10.13	45.03 units on a scale Standard Deviation 11.75
Short Form 36 (SF-36) Mental Component Score Month 18	47.64 units on a scale Standard Deviation 10.32	48.25 units on a scale Standard Deviation 9.86	46.76 units on a scale Standard Deviation 11.49
Short Form 36 (SF-36) Mental Component Score Month 21	46.93 units on a scale Standard Deviation 10.85	48.50 units on a scale Standard Deviation 10.04	46.70 units on a scale Standard Deviation 11.66
Short Form 36 (SF-36) Mental Component Score Month 24	47.32 units on a scale Standard Deviation 10.23	48.96 units on a scale Standard Deviation 10.36	46.42 units on a scale Standard Deviation 10.62

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=395 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=185 Participants 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.
SF-36 Physical Component Score Baseline	32.92 units on a scale Standard Deviation 7.36	33.20 units on a scale Standard Deviation 7.33	33.58 units on a scale Standard Deviation 7.82
SF-36 Physical Component Score Month 1	33.81 units on a scale Standard Deviation 8.47	40.61 units on a scale Standard Deviation 8.11	35.40 units on a scale Standard Deviation 8.28
SF-36 Physical Component Score Month 2	40.98 units on a scale Standard Deviation 8.44	42.52 units on a scale Standard Deviation 8.38	37.51 units on a scale Standard Deviation 8.22
SF-36 Physical Component Score Month 3	42.25 units on a scale Standard Deviation 8.57	43.35 units on a scale Standard Deviation 8.53	38.60 units on a scale Standard Deviation 8.01
SF-36 Physical Component Score Month 6	42.82 units on a scale Standard Deviation 8.42	44.34 units on a scale Standard Deviation 8.79	40.37 units on a scale Standard Deviation 8.11
SF-36 Physical Component Score Month 9	42.96 units on a scale Standard Deviation 8.69	44.77 units on a scale Standard Deviation 8.80	40.30 units on a scale Standard Deviation 7.97
SF-36 Physical Component Score Month 12	43.65 units on a scale Standard Deviation 8.68	45.72 units on a scale Standard Deviation 8.43	41.27 units on a scale Standard Deviation 8.05
SF-36 Physical Component Score Month 15	44.54 units on a scale Standard Deviation 8.83	45.62 units on a scale Standard Deviation 8.78	41.02 units on a scale Standard Deviation 8.27
SF-36 Physical Component Score Month 18	44.53 units on a scale Standard Deviation 8.42	45.50 units on a scale Standard Deviation 8.95	41.15 units on a scale Standard Deviation 8.50
SF-36 Physical Component Score Month 21	45.06 units on a scale Standard Deviation 8.36	45.56 units on a scale Standard Deviation 8.84	41.67 units on a scale Standard Deviation 8.44
SF-36 Physical Component Score Month 24	44.95 units on a scale Standard Deviation 8.76	45.78 units on a scale Standard Deviation 8.50	41.53 units on a scale Standard Deviation 8.30

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=365 Participants 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.	CP-690,550 10 mg BID n=389 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=183 Participants 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.
Change From Baseline in SF-36 Mental Component Score Month 1	4.37 units on a scale Standard Error 0.51	6.14 units on a scale Standard Error 0.49	3.25 units on a scale Standard Error 0.70
Change From Baseline in SF-36 Mental Component Score Month 2	5.39 units on a scale Standard Error 0.51	5.51 units on a scale Standard Error 0.49	3.41 units on a scale Standard Error 0.71
Change From Baseline in SF-36 Mental Component Score Month 3	6.12 units on a scale Standard Error 0.51	5.89 units on a scale Standard Error 0.49	4.33 units on a scale Standard Error 0.72
Change From Baseline in SF-36 Mental Component Score Month 6	6.36 units on a scale Standard Error 0.52	6.53 units on a scale Standard Error 0.50	4.84 units on a scale Standard Error 0.73
Change From Baseline in SF-36 Mental Component Score Month 9	5.99 units on a scale Standard Error 0.52	6.83 units on a scale Standard Error 0.50	6.04 units on a scale Standard Error 0.75
Change From Baseline in SF-36 Mental Component Score Month 12	6.21 units on a scale Standard Error 0.53	6.62 units on a scale Standard Error 0.51	4.72 units on a scale Standard Error 0.77
Change From Baseline in SF-36 Mental Component Score Month 15	6.38 units on a scale Standard Error 0.54	6.30 units on a scale Standard Error 0.52	4.09 units on a scale Standard Error 0.78
Change From Baseline in SF-36 Mental Component Score Month 18	6.51 units on a scale Standard Error 0.54	6.70 units on a scale Standard Error 0.52	5.78 units on a scale Standard Error 0.80
Change From Baseline in SF-36 Mental Component Score Month 21	5.80 units on a scale Standard Error 0.55	6.94 units on a scale Standard Error 0.53	5.58 units on a scale Standard Error 0.81
Change From Baseline in SF-36 Mental Component Score Month 24	6.23 units on a scale Standard Error 0.55	7.49 units on a scale Standard Error 0.53	5.54 units on a scale Standard Error 0.82

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=365 Participants 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.	CP-690,550 10 mg BID n=389 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=183 Participants 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.
Change From Baseline in SF-36 Physical Component Score Month 1	5.83 units on a scale Standard Error 0.43	7.54 units on a scale Standard Error 0.41	2.17 units on a scale Standard Error 0.59
Change From Baseline in SF-36 Physical Component Score Month 2	8.04 units on a scale Standard Error 0.43	9.45 units on a scale Standard Error 0.41	4.23 units on a scale Standard Error 0.60
Change From Baseline in SF-36 Physical Component Score Month 3	9.23 units on a scale Standard Error 0.43	10.32 units on a scale Standard Error 0.41	4.98 units on a scale Standard Error 0.60
Change From Baseline in SF-36 Physical Component Score Month 6	9.66 units on a scale Standard Error 0.44	11.24 units on a scale Standard Error 0.42	6.55 units on a scale Standard Error 0.62
Change From Baseline in SF-36 Physical Component Score Month 9	9.63 units on a scale Standard Error 0.44	11.53 units on a scale Standard Error 0.42	6.56 units on a scale Standard Error 0.63
Change From Baseline in SF-36 Physical Component Score Month 12	10.30 units on a scale Standard Error 0.44	12.35 units on a scale Standard Error 0.43	7.48 units on a scale Standard Error 0.65
Change From Baseline in SF-36 Physical Component Score Month 15	10.87 units on a scale Standard Error 0.45	12.06 units on a scale Standard Error 0.43	7.43 units on a scale Standard Error 0.65
Change From Baseline in SF-36 Physical Component Score Month 18	10.76 units on a scale Standard Error 0.45	12.04 units on a scale Standard Error 0.44	7.47 units on a scale Standard Error 0.67
Change From Baseline in SF-36 Physical Component Score Month 21	11.19 units on a scale Standard Error 0.46	12.19 units on a scale Standard Error 0.44	7.93 units on a scale Standard Error 0.68
Change From Baseline in SF-36 Physical Component Score Month 24	11.03 units on a scale Standard Error 0.46	12.46 units on a scale Standard Error 0.44	7.63 units on a scale Standard Error 0.68

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=396 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
SF-36 Domain Scores Baseline Vitality	41.87 units on a scale Standard Deviation 9.90	41.63 units on a scale Standard Deviation 10.01	41.77 units on a scale Standard Deviation 9.56
SF-36 Domain Scores Month 1 Vitality	47.94 units on a scale Standard Deviation 9.98	48.99 units on a scale Standard Deviation 9.55	44.83 units on a scale Standard Deviation 9.67
SF-36 Domain Scores Month 2 Vitality	49.24 units on a scale Standard Deviation 10.90	49.68 units on a scale Standard Deviation 10.47	45.51 units on a scale Standard Deviation 9.53
SF-36 Domain Scores Month 3 Vitality	50.10 units on a scale Standard Deviation 10.37	50.59 units on a scale Standard Deviation 10.00	47.06 units on a scale Standard Deviation 9.11
SF-36 Domain Scores Month 6 Vitality	50.35 units on a scale Standard Deviation 10.09	50.69 units on a scale Standard Deviation 10.27	48.03 units on a scale Standard Deviation 9.87
SF-36 Domain Scores Month 9 Vitality	50.52 units on a scale Standard Deviation 10.05	51.34 units on a scale Standard Deviation 10.17	48.52 units on a scale Standard Deviation 9.79
SF-36 Domain Scores Month 12 Vitality	50.43 units on a scale Standard Deviation 10.35	51.96 units on a scale Standard Deviation 9.50	48.83 units on a scale Standard Deviation 8.94
SF-36 Domain Scores Month 15 Vitality	51.40 units on a scale Standard Deviation 9.84	51.23 units on a scale Standard Deviation 9.89	48.21 units on a scale Standard Deviation 10.18
SF-36 Domain Scores Month 18 Vitality	51.18 units on a scale Standard Deviation 9.48	51.83 units on a scale Standard Deviation 9.62	48.93 units on a scale Standard Deviation 10.48
SF-36 Domain Scores Month 21 Vitality	51.29 units on a scale Standard Deviation 9.74	51.68 units on a scale Standard Deviation 9.86	49.26 units on a scale Standard Deviation 10.59
SF-36 Domain Scores Month 24 Vitality	50.81 units on a scale Standard Deviation 9.45	52.00 units on a scale Standard Deviation 10.12	49.07 units on a scale Standard Deviation 9.94
SF-36 Domain Scores Baseline Social Functioning	36.41 units on a scale Standard Deviation 11.32	36.66 units on a scale Standard Deviation 11.06	37.64 units on a scale Standard Deviation 11.32
SF-36 Domain Scores Month 1 Social Functioning	41.33 units on a scale Standard Deviation 10.45	44.13 units on a scale Standard Deviation 9.85	40.12 units on a scale Standard Deviation 10.72
SF-36 Domain Scores Month 2 Social Functioning	43.56 units on a scale Standard Deviation 10.89	43.78 units on a scale Standard Deviation 10.44	41.36 units on a scale Standard Deviation 10.28
SF-36 Domain Scores Month 3 Social Functioning	44.75 units on a scale Standard Deviation 10.20	44.60 units on a scale Standard Deviation 10.49	42.52 units on a scale Standard Deviation 9.75
SF-36 Domain Scores Month 6 Social Functioning	45.21 units on a scale Standard Deviation 9.97	46.18 units on a scale Standard Deviation 9.68	44.15 units on a scale Standard Deviation 10.42
SF-36 Domain Scores Month 9 Social Functioning	45.37 units on a scale Standard Deviation 9.47	46.46 units on a scale Standard Deviation 9.50	45.08 units on a scale Standard Deviation 9.71
SF-36 Domain Scores Month 12 Social Functioning	45.43 units on a scale Standard Deviation 10.00	46.88 units on a scale Standard Deviation 9.45	43.22 units on a scale Standard Deviation 9.94
SF-36 Domain Scores Month 15 Social Functioning	46.09 units on a scale Standard Deviation 9.56	46.99 units on a scale Standard Deviation 9.25	42.96 units on a scale Standard Deviation 10.84
SF-36 Domain Scores Month 18 Social Functioning	46.39 units on a scale Standard Deviation 9.32	46.82 units on a scale Standard Deviation 9.34	44.44 units on a scale Standard Deviation 10.94
SF-36 Domain Scores Month 21 Social Functioning	46.22 units on a scale Standard Deviation 9.05	47.22 units on a scale Standard Deviation 9.61	44.49 units on a scale Standard Deviation 9.98
SF-36 Domain Scores Month 24 Social Functioning	46.52 units on a scale Standard Deviation 9.11	47.76 units on a scale Standard Deviation 9.27	43.87 units on a scale Standard Deviation 10.38
SF-36 Domain Scores Basline Role Emotional	34.01 units on a scale Standard Deviation 13.32	34.69 units on a scale Standard Deviation 13.06	34.69 units on a scale Standard Deviation 12.57
SF-36 Domain Scores Month 1 Role Emotional	39.21 units on a scale Standard Deviation 12.35	41.31 units on a scale Standard Deviation 11.72	36.93 units on a scale Standard Deviation 12.10
SF-36 Domain Scores Month 2 Role Emotional	40.59 units on a scale Standard Deviation 12.21	41.60 units on a scale Standard Deviation 11.62	38.30 units on a scale Standard Deviation 11.87
SF-36 Domain Scores Month 3 Role Emotional	41.55 units on a scale Standard Deviation 11.59	42.18 units on a scale Standard Deviation 11.43	39.15 units on a scale Standard Deviation 11.72
SF-36 Domain Scores Month 6 Role Emotional	41.95 units on a scale Standard Deviation 11.69	43.80 units on a scale Standard Deviation 10.75	40.34 units on a scale Standard Deviation 12.72
SF-36 Domain Scores Month 9 Role Emotional	41.84 units on a scale Standard Deviation 11.82	44.08 units on a scale Standard Deviation 10.85	41.12 units on a scale Standard Deviation 11.81
SF-36 Domain Scores Month 12 Role Emotional	42.19 units on a scale Standard Deviation 11.43	44.29 units on a scale Standard Deviation 10.85	40.90 units on a scale Standard Deviation 11.62
SF-36 Domain Scores Month 15 Role Emotional	43.07 units on a scale Standard Deviation 10.93	44.72 units on a scale Standard Deviation 10.98	39.83 units on a scale Standard Deviation 12.09
SF-36 Domain Scores Month 18 Role Emotional	43.36 units on a scale Standard Deviation 11.02	44.00 units on a scale Standard Deviation 10.91	42.43 units on a scale Standard Deviation 11.81
SF-36 Domain Scores Month 21 Role Emotional	42.38 units on a scale Standard Deviation 11.44	44.53 units on a scale Standard Deviation 10.65	41.25 units on a scale Standard Deviation 12.14
SF-36 Domain Scores Month 24 Role Emotional	43.49 units on a scale Standard Deviation 11.12	45.27 units on a scale Standard Deviation 11.02	41.14 units on a scale Standard Deviation 11.68
SF-36 Domain Scores Baseline Mental Health	38.87 units on a scale Standard Deviation 11.88	39.51 units on a scale Standard Deviation 11.76	39.75 units on a scale Standard Deviation 11.30
SF-36 Domain Scores Month 1 Mental Health	43.56 units on a scale Standard Deviation 11.28	45.59 units on a scale Standard Deviation 10.92	42.83 units on a scale Standard Deviation 10.84
SF-36 Domain Scores Month 2 Mental Health	44.57 units on a scale Standard Deviation 12.34	45.27 units on a scale Standard Deviation 11.43	43.35 units on a scale Standard Deviation 10.34
SF-36 Domain Scores Month 3 Mental Health	45.78 units on a scale Standard Deviation 11.73	45.71 units on a scale Standard Deviation 11.86	44.09 units on a scale Standard Deviation 10.55
SF-36 Domain Scores Month 6 Mental Health	46.21 units on a scale Standard Deviation 11.29	46.48 units on a scale Standard Deviation 11.07	44.06 units on a scale Standard Deviation 11.85
SF-36 Domain Scores Month 9 Mental Health	45.85 units on a scale Standard Deviation 11.12	47.31 units on a scale Standard Deviation 10.93	45.41 units on a scale Standard Deviation 11.36
SF-36 Domain Scores Month 12 Mental Health	46.54 units on a scale Standard Deviation 11.33	47.43 units on a scale Standard Deviation 10.68	44.78 units on a scale Standard Deviation 11.25
SF-36 Domain Scores Month 15 Mental Health	46.48 units on a scale Standard Deviation 10.87	47.16 units on a scale Standard Deviation 10.71	44.38 units on a scale Standard Deviation 11.92
SF-36 Domain Scores Month 18 Mental Health	46.78 units on a scale Standard Deviation 10.82	48.05 units on a scale Standard Deviation 10.17	44.95 units on a scale Standard Deviation 12.62
SF-36 Domain Scores Month 21 Mental Health	46.37 units on a scale Standard Deviation 11.64	48.06 units on a scale Standard Deviation 10.74	46.03 units on a scale Standard Deviation 12.31
SF-36 Domain Scores Month 24 Mental Health	46.47 units on a scale Standard Deviation 10.53	48.18 units on a scale Standard Deviation 10.69	45.95 units on a scale Standard Deviation 10.96
SF-36 Domain Scores Baseline Physical Functioning	30.21 units on a scale Standard Deviation 9.47	31.57 units on a scale Standard Deviation 9.86	32.04 units on a scale Standard Deviation 9.57
SF-36 Domain Scores Month 1 Physical Functioning	36.41 units on a scale Standard Deviation 10.45	38.68 units on a scale Standard Deviation 10.31	32.82 units on a scale Standard Deviation 10.09
SF-36 Domain Scores Month 2 Physical Functioning	38.24 units on a scale Standard Deviation 11.05	40.41 units on a scale Standard Deviation 10.82	35.29 units on a scale Standard Deviation 10.26
SF-36 Domain Scores Month 3 Physical Functioning	39.91 units on a scale Standard Deviation 10.77	41.39 units on a scale Standard Deviation 10.84	36.12 units on a scale Standard Deviation 9.97
SF-36 Domain Scores Month 6 Physical Functioning	40.62 units on a scale Standard Deviation 10.98	42.79 units on a scale Standard Deviation 10.83	37.61 units on a scale Standard Deviation 10.17
SF-36 Domain Scores Month 9 Physical Functioning	41.05 units on a scale Standard Deviation 11.03	43.45 units on a scale Standard Deviation 10.23	38.52 units on a scale Standard Deviation 10.34
SF-36 Domain Scores Month 12 Physical Functioning	41.72 units on a scale Standard Deviation 11.20	44.29 units on a scale Standard Deviation 10.17	39.66 units on a scale Standard Deviation 9.70
SF-36 Domain Scores Month 15 Physical Functioning	42.67 units on a scale Standard Deviation 10.84	44.03 units on a scale Standard Deviation 10.58	38.85 units on a scale Standard Deviation 10.12
SF-36 Domain Scores Month 18 Physical Functioning	43.06 units on a scale Standard Deviation 10.32	44.30 units on a scale Standard Deviation 10.64	39.01 units on a scale Standard Deviation 10.90
SF-36 Domain Scores Month 21 Physical Functioning	43.01 units on a scale Standard Deviation 10.65	44.25 units on a scale Standard Deviation 10.31	39.32 units on a scale Standard Deviation 10.57
SF-36 Domain Scores Month 24 Physical Functioning	43.45 units on a scale Standard Deviation 10.29	44.55 units on a scale Standard Deviation 10.40	39.85 units on a scale Standard Deviation 10.74
SF-36 Domain Scores Baseline Role Physical	33.54 units on a scale Standard Deviation 9.64	34.11 units on a scale Standard Deviation 9.35	33.98 units on a scale Standard Deviation 9.42
SF-36 Domain Scores Month 1 Role Physical	39.05 units on a scale Standard Deviation 9.74	41.30 units on a scale Standard Deviation 9.28	36.39 units on a scale Standard Deviation 9.36
SF-36 Domain Scores Month 2 Role Physical	41.30 units on a scale Standard Deviation 9.85	42.73 units on a scale Standard Deviation 9.58	38.43 units on a scale Standard Deviation 9.33
SF-36 Domain Scores Month 3 Role Physical	42.37 units on a scale Standard Deviation 9.83	43.51 units on a scale Standard Deviation 9.43	39.37 units on a scale Standard Deviation 9.67
SF-36 Domain Scores Month 6 Role Physical	43.27 units on a scale Standard Deviation 9.42	44.46 units on a scale Standard Deviation 9.82	40.78 units on a scale Standard Deviation 9.76
SF-36 Domain Scores Month 9 Role Physical	42.78 units on a scale Standard Deviation 9.60	45.04 units on a scale Standard Deviation 9.47	40.80 units on a scale Standard Deviation 9.66
SF-36 Domain Scores Month 12 Role Physical	43.67 units on a scale Standard Deviation 9.36	45.81 units on a scale Standard Deviation 9.39	41.28 units on a scale Standard Deviation 9.28
SF-36 Domain Scores Month 15 Role Physical	44.46 units on a scale Standard Deviation 9.41	45.90 units on a scale Standard Deviation 9.47	41.17 units on a scale Standard Deviation 9.35
SF-36 Domain Scores Month 18 Role Physical	44.44 units on a scale Standard Deviation 90.4	45.27 units on a scale Standard Deviation 9.30	42.31 units on a scale Standard Deviation 10.15
SF-36 Domain Scores Month 21 Role Physical	44.51 units on a scale Standard Deviation 9.18	45.77 units on a scale Standard Deviation 9.45	42.72 units on a scale Standard Deviation 9.72
SF-36 Domain Scores Month 24 Role Physical	44.73 units on a scale Standard Deviation 9.34	46.20 units on a scale Standard Deviation 9.04	41.83 units on a scale Standard Deviation 10.15
SF-36 Domain Scores Baseline Bodily Pain	33.29 units on a scale Standard Deviation 8.11	33.27 units on a scale Standard Deviation 7.25	33.80 units on a scale Standard Deviation 7.53
SF-36 Domain Scores Month 1 Bodily Pain	40.54 units on a scale Standard Deviation 8.47	42.81 units on a scale Standard Deviation 8.57	37.54 units on a scale Standard Deviation 7.55
SF-36 Domain Scores Month 2 Bodily Pain	42.78 units on a scale Standard Deviation 9.09	44.15 units on a scale Standard Deviation 9.19	38.93 units on a scale Standard Deviation 7.89
SF-36 Domain Scores Month 3 Bodily Pain	44.14 units on a scale Standard Deviation 8.73	44.79 units on a scale Standard Deviation 9.35	40.61 units on a scale Standard Deviation 8.19
SF-36 Domain Scores Month 6 Bodily Pain	44.44 units on a scale Standard Deviation 8.87	46.05 units on a scale Standard Deviation 9.47	42.36 units on a scale Standard Deviation 8.66
SF-36 Domain Scores Month 9 Bodily Pain	44.37 units on a scale Standard Deviation 8.90	46.40 units on a scale Standard Deviation 9.58	42.62 units on a scale Standard Deviation 8.32
SF-36 Domain Scores Month 12 Bodily Pain	45.32 units on a scale Standard Deviation 9.32	47.17 units on a scale Standard Deviation 9.25	42.47 units on a scale Standard Deviation 8.85
SF-36 Domain Scores Month 15 Bodily Pain	45.97 units on a scale Standard Deviation 9.38	47.18 units on a scale Standard Deviation 9.34	42.72 units on a scale Standard Deviation 9.75
SF-36 Domain Scores Month 18 Bodily Pain	45.72 units on a scale Standard Deviation 9.26	47.38 units on a scale Standard Deviation 9.31	43.35 units on a scale Standard Deviation 9.25
SF-36 Domain Scores Month 21 Bodily Pain	46.42 units on a scale Standard Deviation 9.30	47.43 units on a scale Standard Deviation 9.34	43.70 units on a scale Standard Deviation 9.47
SF-36 Domain Scores Month 24 Bodily Pain	46.24 units on a scale Standard Deviation 9.46	47.66 units on a scale Standard Deviation 9.42	43.37 units on a scale Standard Deviation 9.43
SF-36 Domain Scores Baseline General Health Perception	38.02 units on a scale Standard Deviation 9.03	37.24 units on a scale Standard Deviation 8.55	37.63 units on a scale Standard Deviation 8.60
SF-36 Domain Scores Month 1 General Health Perception	41.69 units on a scale Standard Deviation 9.37	42.40 units on a scale Standard Deviation 8.78	39.58 units on a scale Standard Deviation 8.69
SF-36 Domain Scores Month 2 General Health Perception	43.11 units on a scale Standard Deviation 9.19	43.18 units on a scale Standard Deviation 9.19	40.68 units on a scale Standard Deviation 8.10
SF-36 Domain Scores Month 3 General Health Perception	43.86 units on a scale Standard Deviation 9.43	43.72 units on a scale Standard Deviation 8.99	41.35 units on a scale Standard Deviation 8.07
SF-36 Domain Scores Month 6 General Health Perception	44.00 units on a scale Standard Deviation 9.48	44.32 units on a scale Standard Deviation 9.24	42.53 units on a scale Standard Deviation 8.11
SF-36 Domain Scores Month 9 General Health Perception	44.17 units on a scale Standard Deviation 9.32	44.53 units on a scale Standard Deviation 9.73	42.09 units on a scale Standard Deviation 8.51
SF-36 Domain Scores Month 12 General Health Perception	44.24 units on a scale Standard Deviation 9.18	45.06 units on a scale Standard Deviation 9.35	42.74 units on a scale Standard Deviation 8.30
SF-36 Domain Scores Month 15 General Health Perception	44.78 units on a scale Standard Deviation 9.23	45.14 units on a scale Standard Deviation 9.40	41.85 units on a scale Standard Deviation 8.40
SF-36 Domain Scores Month 18 General Health Perception	44.92 units on a scale Standard Deviation 8.93	45.00 units on a scale Standard Deviation 9.60	42.15 units on a scale Standard Deviation 9.92
SF-36 Domain Scores Month 21 General Health Perception	45.03 units on a scale Standard Deviation 9.08	45.02 units on a scale Standard Deviation 9.73	42.69 units on a scale Standard Deviation 9.06
SF-36 Domain Scores Month 24 General Health Perception	44.75 units on a scale Standard Deviation 8.78	45.14 units on a scale Standard Deviation 9.41	42.75 units on a scale Standard Deviation 8.65

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=365 Participants 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.	CP-690,550 10 mg BID n=391 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Change From Baseline in SF-36 Domain Scores Month 15 Role Emotional	8.21 units on a scale Standard Error 0.59	9.61 units on a scale Standard Error 0.57	4.97 units on a scale Standard Error 0.86
Change From Baseline in SF-36 Domain Scores Month 18 Role Emotional	8.43 units on a scale Standard Error 0.60	9.16 units on a scale Standard Error 0.58	7.53 units on a scale Standard Error 0.89
Change From Baseline in SF-36 Domain Scores Month 21 Social Functioning	8.76 units on a scale Standard Error 0.54	9.87 units on a scale Standard Error 0.52	7.37 units on a scale Standard Error 0.80
Change From Baseline in SF-36 Domain Scores Month 24 Social Functioning	9.05 units on a scale Standard Error 0.55	10.43 units on a scale Standard Error 0.53	6.85 units on a scale Standard Error 0.82
Change From Baseline in SF-36 Domain Scores Month 1 Role Emotional	5.06 units on a scale Standard Error 0.56	6.88 units on a scale Standard Error 0.54	2.58 units on a scale Standard Error 0.77
Change From Baseline in SF-36 Domain Scores Month 2 Role Emotional	6.39 units on a scale Standard Error 0.56	7.26 units on a scale Standard Error 0.54	3.62 units on a scale Standard Error 0.78
Change From Baseline in SF-36 Domain Scores Month 3 Role Emotional	7.20 units on a scale Standard Error 0.56	7.73 units on a scale Standard Error 0.54	4.38 units on a scale Standard Error 0.79
Change From Baseline in SF-36 Domain Scores Month 6 Role Emotional	7.49 units on a scale Standard Error 0.57	9.17 units on a scale Standard Error 0.55	5.58 units on a scale Standard Error 0.81
Change From Baseline in SF-36 Domain Scores Month 9 Role Emotional	7.21 units on a scale Standard Error 0.58	9.35 units on a scale Standard Error 0.55	6.37 units on a scale Standard Error 0.83
Change From Baseline in SF-36 Domain Scores Month 12 Role Emotional	7.63 units on a scale Standard Error 0.58	9.38 units on a scale Standard Error 0.56	5.94 units on a scale Standard Error 0.85
Change From Baseline in SF-36 Domain Scores Month 1 Vitality	6.04 units on a scale Standard Error 0.49	7.27 units on a scale Standard Error 0.47	3.03 units on a scale Standard Error 0.68
Change From Baseline in SF-36 Domain Scores Month 2 Vitality	7.36 units on a scale Standard Error 0.49	7.94 units on a scale Standard Error 0.47	3.68 units on a scale Standard Error 0.69
Change From Baseline in SF-36 Domain Scores Month 3 Vitality	8.13 units on a scale Standard Error 0.49	8.79 units on a scale Standard Error 0.47	4.99 units on a scale Standard Error 0.69
Change From Baseline in SF-36 Domain Scores Month 6 Vitality	8.36 units on a scale Standard Error 0.50	8.58 units on a scale Standard Error 0.48	5.89 units on a scale Standard Error 0.71
Change From Baseline in SF-36 Domain Scores Month 9 Vitality	8.32 units on a scale Standard Error 0.50	9.06 units on a scale Standard Error 0.49	6.33 units on a scale Standard Error 0.73
Change From Baseline in SF-36 Domain Scores Month 12 Vitality	8.30 units on a scale Standard Error 0.51	9.31 units on a scale Standard Error 0.49	6.44 units on a scale Standard Error 0.74
Change From Baseline in SF-36 Domain Scores Month 15 Vitality	9.00 units on a scale Standard Error 0.52	8.33 units on a scale Standard Error 0.50	5.79 units on a scale Standard Error 0.75
Change From Baseline in SF-36 Domain Scores Month 18 Vitality	8.65 units on a scale Standard Error 0.52	9.09 units on a scale Standard Error 0.51	6.46 units on a scale Standard Error 0.77
Change From Baseline in SF-36 Domain Scores Month 21 Vitality	8.66 units on a scale Standard Error 0.53	8.94 units on a scale Standard Error 0.51	6.73 units on a scale Standard Error 0.78
Change From Baseline in SF-36 Domain Scores Month 24 Vitality	8.19 units on a scale Standard Error 0.53	9.29 units on a scale Standard Error 0.51	6.47 units on a scale Standard Error 0.79
Change From Baseline in SF-36 Domain Scores Month 1 Social Functioning	4.69 units on a scale Standard Error 0.50	7.46 units on a scale Standard Error 0.48	3.10 units on a scale Standard Error 0.69
Change From Baseline in SF-36 Domain Scores Month 2 Social Functioning	6.97 units on a scale Standard Error 0.50	7.15 units on a scale Standard Error 0.48	4.18 units on a scale Standard Error 0.70
Change From Baseline in SF-36 Domain Scores Month 3 Social Functioning	8.06 units on a scale Standard Error 0.50	7.90 units on a scale Standard Error 0.48	5.18 units on a scale Standard Error 0.71
Change From Baseline in SF-36 Domain Scores Month 6 Social Functioning	8.35 units on a scale Standard Error 0.51	9.23 units on a scale Standard Error 0.49	6.82 units on a scale Standard Error 0.72
Change From Baseline in SF-36 Domain Scores Month 9 Social Functioning	8.39 units on a scale Standard Error 0.51	9.37 units on a scale Standard Error 0.49	7.78 units on a scale Standard Error 0.75
Change From Baseline in SF-36 Domain Scores Month 12 Social Functioning	8.46 units on a scale Standard Error 0.52	9.60 units on a scale Standard Error 0.50	5.83 units on a scale Standard Error 0.76
Change From Baseline in SF-36 Domain Scores Month 15 Social Functioning	8.85 units on a scale Standard Error 0.53	9.49 units on a scale Standard Error 0.51	5.85 units on a scale Standard Error 0.77
Change From Baseline in SF-36 Domain Scores Month 18 Social Functioning	8.99 units on a scale Standard Error 0.54	9.44 units on a scale Standard Error 0.52	7.33 units on a scale Standard Error 0.79
Change From Baseline in SF-36 Domain Scores Month 21 Role Emotional	7.48 units on a scale Standard Error 0.60	9.70 units on a scale Standard Error 0.58	6.32 units on a scale Standard Error 0.90
Change From Baseline in SF-36 Domain Scores Month 24 Role Emotional	8.61 units on a scale Standard Error 0.61	10.51 units on a scale Standard Error 0.59	6.59 units on a scale Standard Error 0.91
Change From Baseline in SF-36 Domain Scores Month 1 Mental Health	4.57 units on a scale Standard Error 0.52	6.37 units on a scale Standard Error 0.50	3.50 units on a scale Standard Error 0.72
Change From Baseline in SF-36 Domain Scores Month 2 Mental Health	5.53 units on a scale Standard Error 0.52	6.05 units on a scale Standard Error 0.50	3.94 units on a scale Standard Error 0.72
Change From Baseline in SF-36 Domain Scores Month 3 Mental Health	6.59 units on a scale Standard Error 0.52	6.35 units on a scale Standard Error 0.50	4.67 units on a scale Standard Error 0.73
Change From Baseline in SF-36 Domain Scores Month 6 Mental Health	7.05 units on a scale Standard Error 0.53	6.81 units on a scale Standard Error 0.51	4.65 units on a scale Standard Error 0.75
Change From Baseline in SF-36 Domain Scores Month 9 Mental Health	6.46 units on a scale Standard Error 0.53	7.39 units on a scale Standard Error 0.51	6.10 units on a scale Standard Error 0.77
Change From Baseline in SF-36 Domain Scores Month 12 Mental Health	7.27 units on a scale Standard Error 0.54	7.31 units on a scale Standard Error 0.52	5.38 units on a scale Standard Error 0.78
Change From Baseline in SF-36 Domain Scores Month 15 Mental Health	7.01 units on a scale Standard Error 0.55	6.73 units on a scale Standard Error 0.53	5.02 units on a scale Standard Error 0.79
Change From Baseline in SF-36 Domain Scores Month 18 Mental Health	7.21 units on a scale Standard Error 0.55	7.74 units on a scale Standard Error 0.54	5.41 units on a scale Standard Error 0.82
Change From Baseline in SF-36 Domain Scores Month 21 Mental Health	6.78 units on a scale Standard Error 0.56	7.75 units on a scale Standard Error 0.54	6.39 units on a scale Standard Error 0.83
Change From Baseline in SF-36 Domain Scores Month 24 Mental Health	6.88 units on a scale Standard Error 0.56	8.05 units on a scale Standard Error 0.54	6.40 units on a scale Standard Error 0.84
Change From Baseline in SF-36 Domain Scores Month 1 Physical Functioning	5.74 units on a scale Standard Error 0.52	7.41 units on a scale Standard Error 0.49	1.34 units on a scale Standard Error 0.71
Change From Baseline in SF-36 Domain Scores Month 2 Physical Functioning	7.59 units on a scale Standard Error 0.52	9.19 units on a scale Standard Error 0.50	3.66 units on a scale Standard Error 0.72
Change From Baseline in SF-36 Domain Scores Month 3 Physical Functioning	9.18 units on a scale Standard Error 0.52	10.16 units on a scale Standard Error 0.50	4.30 units on a scale Standard Error 0.73
Change From Baseline in SF-36 Domain Scores Month 6 Physical Functioning	9.70 units on a scale Standard Error 0.53	11.39 units on a scale Standard Error 0.50	5.69 units on a scale Standard Error 0.74
Change From Baseline in SF-36 Domain Scores Month 9 Physical Functioning	9.98 units on a scale Standard Error 0.53	12.00 units on a scale Standard Error 0.51	6.32 units on a scale Standard Error 0.76
Change From Baseline in SF-36 Domain Scores Month 12 Physical Functioning	10.68 units on a scale Standard Error 0.54	12.76 units on a scale Standard Error 0.52	7.41 units on a scale Standard Error 0.77
Change From Baseline in SF-36 Domain Scores Month 15 Physical Functioning	11.18 units on a scale Standard Error 0.55	12.29 units on a scale Standard Error 0.52	6.89 units on a scale Standard Error 0.79
Change From Baseline in SF-36 Domain Scores Month 18 Physical Functioning	11.50 units on a scale Standard Error 0.55	12.66 units on a scale Standard Error 0.53	7.05 units on a scale Standard Error 0.81
Change From Baseline in SF-36 Domain Scores Month 21 Physical Functioning	11.33 units on a scale Standard Error 0.55	12.71 units on a scale Standard Error 0.53	7.35 units on a scale Standard Error 0.82
Change From Baseline in SF-36 Domain Scores Month 24 Physical Functioning	11.66 units on a scale Standard Error 0.56	13.04 units on a scale Standard Error 0.54	7.93 units on a scale Standard Error 0.83
Change From Baseline in SF-36 Domain Scores Month 1 Role Physical	5.52 units on a scale Standard Error 0.48	7.57 units on a scale Standard Error 0.46	2.75 units on a scale Standard Error 0.66
Change From Baseline in SF-36 Domain Scores Month 2 Role Physical	7.81 units on a scale Standard Error 0.48	9.05 units on a scale Standard Error 0.46	4.57 units on a scale Standard Error 0.67
Change From Baseline in SF-36 Domain Scores Month 3 Role Physical	8.77 units on a scale Standard Error 0.48	9.81 units on a scale Standard Error 0.46	5.24 units on a scale Standard Error 0.67
Change From Baseline in SF-36 Domain Scores Month 6 Role Physical	9.55 units on a scale Standard Error 0.49	10.63 units on a scale Standard Error 0.47	6.60 units on a scale Standard Error 0.69
Change From Baseline in SF-36 Domain Scores Month 9 Role Physical	8.88 units on a scale Standard Error 0.49	11.13 units on a scale Standard Error 0.47	6.57 units on a scale Standard Error 0.71
Change From Baseline in SF-36 Domain Scores Month 12 Role Physical	9.79 units on a scale Standard Error 0.50	11.72 units on a scale Standard Error 0.48	7.03 units on a scale Standard Error 0.72
Change From Baseline in SF-36 Domain Scores Month 15 Role Physical	10.27 units on a scale Standard Error 0.50	11.64 units on a scale Standard Error 0.49	7.06 units on a scale Standard Error 0.73
Change From Baseline in SF-36 Domain Scores Month 18 Role Physical	10.10 units on a scale Standard Error 0.51	11.23 units on a scale Standard Error 0.49	8.20 units on a scale Standard Error 0.75
Change From Baseline in SF-36 Domain Scores Month 21 Role Physical	10.11 units on a scale Standard Error 0.51	11.78 units on a scale Standard Error 0.49	8.65 units on a scale Standard Error 0.76
Change From Baseline in SF-36 Domain Scores Month 24 Role Physical	10.31 units on a scale Standard Error 0.52	12.26 units on a scale Standard Error 0.50	7.78 units on a scale Standard Error 0.77
Change From Baseline in SF-36 Domain Scores Month 1 Bodily Pain	7.21 units on a scale Standard Error 0.48	9.54 units on a scale Standard Error 0.46	4.10 units on a scale Standard Error 0.66
Change From Baseline in SF-36 Domain Scores Month 2 Bodily Pain	9.45 units on a scale Standard Error 0.48	10.88 units on a scale Standard Error 0.46	5.40 units on a scale Standard Error 0.67
Change From Baseline in SF-36 Domain Scores Month 3 Bodily Pain	10.69 units on a scale Standard Error 0.48	11.49 units on a scale Standard Error 0.46	6.81 units on a scale Standard Error 0.68
Change From Baseline in SF-36 Domain Scores Month 6 Bodily Pain	10.90 units on a scale Standard Error 0.49	12.58 units on a scale Standard Error 0.47	8.32 units on a scale Standard Error 0.69
Change From Baseline in SF-36 Domain Scores Month 9 Bodily Pain	10.66 units on a scale Standard Error 0.49	12.74 units on a scale Standard Error 0.47	8.77 units on a scale Standard Error 0.71
Change From Baseline in SF-36 Domain Scores Month 12 Bodily Pain	11.64 units on a scale Standard Error 0.50	13.32 units on a scale Standard Error 0.48	8.43 units on a scale Standard Error 0.73
Change From Baseline in SF-36 Domain Scores Month 15 Bodily Pain	12.09 units on a scale Standard Error 0.51	13.10 units on a scale Standard Error 0.49	8.72 units on a scale Standard Error 0.74
Change From Baseline in SF-36 Domain Scores Month 18 Bodily Pain	11.75 units on a scale Standard Error 0.51	13.43 units on a scale Standard Error 0.50	9.11 units on a scale Standard Error 0.76
Change From Baseline in SF-36 Domain Scores Month 21 Bodily Pain	12.35 units on a scale Standard Error 0.52	13.52 units on a scale Standard Error 0.50	9.39 units on a scale Standard Error 0.77
Change From Baseline in SF-36 Domain Scores Month 24 Bodily Pain	12.16 units on a scale Standard Error 0.52	13.80 units on a scale Standard Error 0.50	9.06 units on a scale Standard Error 0.78
Change From Baseline in SF-36 Domain Scores Month 1 General Health Perception	3.94 units on a scale Standard Error 0.41	5.19 units on a scale Standard Error 0.39	2.15 units on a scale Standard Error 0.57
Change From Baseline in SF-36 Domain Scores Month 2 General Health Perception	5.37 units on a scale Standard Error 0.41	5.97 units on a scale Standard Error 0.39	3.27 units on a scale Standard Error 0.57
Change From Baseline in SF-36 Domain Scores Month 3 General Health Perception	6.04 units on a scale Standard Error 0.41	6.44 units on a scale Standard Error 0.39	3.86 units on a scale Standard Error 0.58
Change From Baseline in SF-36 Domain Scores Month 6 General Health Perception	6.14 units on a scale Standard Error 0.42	6.84 units on a scale Standard Error 0.40	4.87 units on a scale Standard Error 0.59
Change From Baseline in SF-36 Domain Scores Month 9 General Health Perception	6.08 units on a scale Standard Error 0.42	6.89 units on a scale Standard Error 0.40	4.71 units on a scale Standard Error 0.60
Change From Baseline in SF-36 Domain Scores Month 12 General Health Perception	6.08 units on a scale Standard Error 0.42	7.20 units on a scale Standard Error 0.41	5.33 units on a scale Standard Error 0.61
Change From Baseline in SF-36 Domain Scores Month 15 General Health Perception	6.41 units on a scale Standard Error 0.43	7.04 units on a scale Standard Error 0.41	4.57 units on a scale Standard Error 0.62
Change From Baseline in SF-36 Domain Scores Month 18 General Health Perception	6.50 units on a scale Standard Error 0.43	6.95 units on a scale Standard Error 0.42	4.61 units on a scale Standard Error 0.64
Change From Baseline in SF-36 Domain Scores Month 21 General Health Perception	6.62 units on a scale Standard Error 0.44	7.06 units on a scale Standard Error 0.42	4.96 units on a scale Standard Error 0.64
Change From Baseline in SF-36 Domain Scores Month 24 General Health Perception	6.39 units on a scale Standard Error 0.44	7.37 units on a scale Standard Error 0.42	4.75 units on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=194 Participants 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.	CP-690,550 10 mg BID n=212 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=99 Participants 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.
Work Limitation Questionnaire (WLQ) Score Baseline: Time Management	46.41 units on a scale Standard Deviation 25.59	47.79 units on a scale Standard Deviation 28.29	47.26 units on a scale Standard Deviation 28.19
Work Limitation Questionnaire (WLQ) Score Baseline: Physical Demands	51.18 units on a scale Standard Deviation 23.02	50.99 units on a scale Standard Deviation 25.47	50.15 units on a scale Standard Deviation 25.54
Work Limitation Questionnaire (WLQ) Score Baseline: Mental Demands	31.29 units on a scale Standard Deviation 24.72	33.84 units on a scale Standard Deviation 26.72	28.57 units on a scale Standard Deviation 26.35
Work Limitation Questionnaire (WLQ) Score Baseline: Output Demands	40.77 units on a scale Standard Deviation 27.36	40.50 units on a scale Standard Deviation 28.07	38.34 units on a scale Standard Deviation 28.09
Work Limitation Questionnaire (WLQ) Score Month 21: Physical Demands	62.50 units on a scale Standard Deviation 29.17	27.08 units on a scale Standard Deviation 20.62	62.50 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Work Limitation Questionnaire (WLQ) Score Month 1: Time Management	40.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	37.50 units on a scale Standard Deviation 53.03	40.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Work Limitation Questionnaire (WLQ) Score Month 2: Time Management	25.00 units on a scale Standard Deviation 35.36	15.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	95.00 units on a scale Standard Deviation 8.66
Work Limitation Questionnaire (WLQ) Score Month 3: Time Management	31.47 units on a scale Standard Deviation 27.99	29.02 units on a scale Standard Deviation 29.19	34.76 units on a scale Standard Deviation 27.70
Work Limitation Questionnaire (WLQ) Score Month 3: Physical Demands	48.11 units on a scale Standard Deviation 31.33	45.77 units on a scale Standard Deviation 32.86	54.47 units on a scale Standard Deviation 28.36
Work Limitation Questionnaire (WLQ) Score Month 3: Mental Demands	23.84 units on a scale Standard Deviation 26.67	22.50 units on a scale Standard Deviation 27.28	22.66 units on a scale Standard Deviation 24.71
Work Limitation Questionnaire (WLQ) Score Month 3: Output Demands	26.46 units on a scale Standard Deviation 26.26	25.63 units on a scale Standard Deviation 28.30	27.77 units on a scale Standard Deviation 26.38
Work Limitation Questionnaire (WLQ) Score Month 6: Physical Demands	50.13 units on a scale Standard Deviation 31.81	45.76 units on a scale Standard Deviation 35.45	46.46 units on a scale Standard Deviation 30.78
Work Limitation Questionnaire (WLQ) Score Month 6: Time Management	29.18 units on a scale Standard Deviation 28.16	25.11 units on a scale Standard Deviation 28.08	27.87 units on a scale Standard Deviation 25.18
Work Limitation Questionnaire (WLQ) Score Month 6: Mental Demands	22.01 units on a scale Standard Deviation 24.05	18.00 units on a scale Standard Deviation 24.11	20.29 units on a scale Standard Deviation 23.90
Work Limitation Questionnaire (WLQ) Score Month 6: Output Demands	24.55 units on a scale Standard Deviation 24.47	20.31 units on a scale Standard Deviation 23.33	24.66 units on a scale Standard Deviation 25.38
Work Limitation Questionnaire (WLQ) Score Month 9: Time Management	70.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	35.00 units on a scale Standard Deviation 33.91	62.92 units on a scale Standard Deviation 32.12
Work Limitation Questionnaire (WLQ) Score Month 12: Time Management	30.82 units on a scale Standard Deviation 29.76	24.43 units on a scale Standard Deviation 28.49	25.86 units on a scale Standard Deviation 25.57
Work Limitation Questionnaire (WLQ) Score Month 12: Physical Demands	47.87 units on a scale Standard Deviation 33.29	46.42 units on a scale Standard Deviation 37.18	39.98 units on a scale Standard Deviation 32.42
Work Limitation Questionnaire (WLQ) Score Month 12: Mental Demands	22.99 units on a scale Standard Deviation 25.59	15.11 units on a scale Standard Deviation 21.94	17.21 units on a scale Standard Deviation 21.88
Work Limitation Questionnaire (WLQ) Score Month 12: Output Demands	25.65 units on a scale Standard Deviation 25.74	17.36 units on a scale Standard Deviation 22.98	21.49 units on a scale Standard Deviation 26.87
Work Limitation Questionnaire (WLQ) Score Month 15: Time Management	5.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	8.33 units on a scale Standard Deviation 14.43	75.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Work Limitation Questionnaire (WLQ) Score Month 15: Physical Demands	8.33 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	33.33 units on a scale Standard Deviation 57.74	54.17 units on a scale Standard Deviation 25.34
Work Limitation Questionnaire (WLQ) Score Month 15: Mental Demands	5.56 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	0.00 units on a scale Standard Deviation 0.00	37.50 units on a scale Standard Deviation 53.03
Work Limitation Questionnaire (WLQ) Score Month 15: Output Demands	0.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	6.67 units on a scale Standard Deviation 11.55	48.33 units on a scale Standard Deviation 44.78
Work Limitation Questionnaire (WLQ) Score Month 18: Time Management	23.19 units on a scale Standard Deviation 25.28	22.16 units on a scale Standard Deviation 26.77	25.09 units on a scale Standard Deviation 28.46
Work Limitation Questionnaire (WLQ) Score Month 18: Physical Demands	50.79 units on a scale Standard Deviation 34.51	43.14 units on a scale Standard Deviation 37.06	43.93 units on a scale Standard Deviation 33.15
Work Limitation Questionnaire (WLQ) Score Month 18: Mental Demands	19.24 units on a scale Standard Deviation 23.15	17.51 units on a scale Standard Deviation 23.83	17.78 units on a scale Standard Deviation 22.99
Work Limitation Questionnaire (WLQ) Score Month 18: Output Demands	22.85 units on a scale Standard Deviation 24.60	19.83 units on a scale Standard Deviation 25.37	22.63 units on a scale Standard Deviation 26.31
Work Limitation Questionnaire (WLQ) Score Month 21: Time Management	67.50 units on a scale Standard Deviation 17.68	60.00 units on a scale Standard Deviation 35.36	80.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Work Limitation Questionnaire (WLQ) Score Month 21: Mental Demands	29.63 units on a scale Standard Deviation 26.98	87.50 units on a scale Standard Deviation 17.68	25.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Work Limitation Questionnaire (WLQ) Score Month 21: Output Demands	31.67 units on a scale Standard Deviation 27.54	82.50 units on a scale Standard Deviation 24.75	45.00 units on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Work Limitation Questionnaire (WLQ) Score Month 24: Time Management	28.17 units on a scale Standard Deviation 29.38	21.06 units on a scale Standard Deviation 25.37	25.11 units on a scale Standard Deviation 25.07
Work Limitation Questionnaire (WLQ) Score Month 24: Physical Demands	51.10 units on a scale Standard Deviation 35.26	45.94 units on a scale Standard Deviation 36.65	43.75 units on a scale Standard Deviation 33.06
Work Limitation Questionnaire (WLQ) Score Month 24: Mental Demands	19.44 units on a scale Standard Deviation 22.70	17.25 units on a scale Standard Deviation 23.29	17.50 units on a scale Standard Deviation 24.04
Work Limitation Questionnaire (WLQ) Score Month 24: Output Demands	22.98 units on a scale Standard Deviation 25.23	19.39 units on a scale Standard Deviation 24.03	20.02 units on a scale Standard Deviation 23.85

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=170 Participants 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.	CP-690,550 10 mg BID n=177 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=81 Participants 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.
Change From Baseline in WLQ Scores Month 3 Time Management Scale	-14.28 units on a scale Standard Error 2.11	-16.87 units on a scale Standard Error 2.04	-10.46 units on a scale Standard Error 2.98
Change From Baseline in WLQ Scores Month 6 Time Management Scale	-16.99 units on a scale Standard Error 2.16	-20.12 units on a scale Standard Error 2.10	-15.78 units on a scale Standard Error 3.10
Change From Baseline in WLQ Scores Month 12 Time Management Scale	-16.22 units on a scale Standard Error 2.23	-20.72 units on a scale Standard Error 2.20	-18.32 units on a scale Standard Error 3.29
Change From Baseline in WLQ Scores Month 15 Time Management Scale	-32.18 units on a scale Standard Error 21.24	-14.92 units on a scale Standard Error 15.04	29.59 units on a scale Standard Error 21.29
Change From Baseline in WLQ Scores Month 18 Time Management Scale	-21.55 units on a scale Standard Error 2.33	-22.60 units on a scale Standard Error 2.30	-18.68 units on a scale Standard Error 3.47
Change From Baseline in WLQ Scores Month 21 Time Management Scale	5.99 units on a scale Standard Error 14.90	-16.26 units on a scale Standard Error 20.82	-7.27 units on a scale Standard Error 20.89
Change From Baseline in WLQ Scores Month 24 Time Management Scale	-15.44 units on a scale Standard Error 2.37	-22.25 units on a scale Standard Error 2.35	-18.54 units on a scale Standard Error 3.64
Change From Baseline in WLQ Scores Month 3 Physical Demand	-6.44 units on a scale Standard Error 2.62	-8.36 units on a scale Standard Error 2.55	0.13 units on a scale Standard Error 3.74
Change From Baseline in WLQ Scores Month 6 Physical Demand	-1.25 units on a scale Standard Error 2.68	-9.48 units on a scale Standard Error 2.64	-6.45 units on a scale Standard Error 3.88
Change From Baseline in WLQ Scores Month 12 Physical Demand	-5.36 units on a scale Standard Error 2.77	-6.66 units on a scale Standard Error 2.76	-14.62 units on a scale Standard Error 4.11
Change From Baseline in WLQ Scores Month 15 Physical Demand	-28.94 units on a scale Standard Error 28.32	-12.26 units on a scale Standard Error 16.51	-13.80 units on a scale Standard Error 16.68
Change From Baseline in WLQ Scores Month 18 Physical Demand	-2.35 units on a scale Standard Error 2.86	-11.77 units on a scale Standard Error 2.95	-7.77 units on a scale Standard Error 4.38
Change From Baseline in WLQ Scores Month 21 Physical Demand	3.65 units on a scale Standard Error 16.22	-18.17 units on a scale Standard Error 27.87	4.80 units on a scale Standard Error 27.94
Change From Baseline in WLQ Scores Month 24 Physical Demand	-2.71 units on a scale Standard Error 3.02	-9.56 units on a scale Standard Error 3.03	-8.03 units on a scale Standard Error 4.62
Change From Baseline in WLQ Scores Month 3 Mental/Interpersonal Demands	-6.81 units on a scale Standard Error 1.68	-8.56 units on a scale Standard Error 1.64	-5.99 units on a scale Standard Error 2.39
Change From Baseline in WLQ Scores Month 6 Mental/Interpersonal Demands	-10.03 units on a scale Standard Error 1.72	-12.35 units on a scale Standard Error 1.69	-9.36 units on a scale Standard Error 2.49
Change From Baseline in WLQ Scores Month 12 Mental/Interpersonal Demands	-9.35 units on a scale Standard Error 1.77	-15.21 units on a scale Standard Error 11.76	-11.64 units on a scale Standard Error 2.63
Change From Baseline in WLQ Scores Month 15 Mental/Interpersonal Demands	-17.52 units on a scale Standard Error 17.41	-21.78 units on a scale Standard Error 10.18	15.00 units on a scale Standard Error 12.54
Change From Baseline in WLQ Scores Month 18 Mental/Interpersonal Demands	-11.09 units on a scale Standard Error 1.83	-13.08 units on a scale Standard Error 1.86	-11.33 units on a scale Standard Error 2.76
Change From Baseline in WLQ Scores Month 21 Mental/Interpersonal Demands	-4.00 units on a scale Standard Error 9.96	23.24 units on a scale Standard Error 17.09	-29.23 units on a scale Standard Error 17.14
Change From Baseline in WLQ Scores Month 24 Mental/Interpersonal Demands	-9.34 units on a scale Standard Error 1.89	-13.58 units on a scale Standard Error 1.90	-13.14 units on a scale Standard Error 2.87
Change From Baseline in WLQ Scores Month 3 Output Demand	-12.69 units on a scale Standard Error 1.84	-13.43 units on a scale Standard Error 1.82	-8.73 units on a scale Standard Error 2.72
Change From Baseline in WLQ Scores Month 6 Output Demand	-14.78 units on a scale Standard Error 1.89	-19.16 units on a scale Standard Error 1.89	-14.02 units on a scale Standard Error 2.80
Change From Baseline in WLQ Scores Month 12 Output Demand	-14.83 units on a scale Standard Error 1.93	-21.15 units on a scale Standard Error 1.96	-15.84 units on a scale Standard Error 2.95
Change From Baseline in WLQ Scores Month 15 Output Demand	-29.63 units on a scale Standard Error 18.09	-18.43 units on a scale Standard Error 10.61	17.17 units on a scale Standard Error 13.10
Change From Baseline in WLQ Scores Month 18 Output Demand	-14.17 units on a scale Standard Error 1.98	-18.82 units on a scale Standard Error 2.06	-14.15 units on a scale Standard Error 3.09
Change From Baseline in WLQ Scores Month 21 Output Demand	0.32 units on a scale Standard Error 12.69	16.85 units on a scale Standard Error 17.72	-20.75 units on a scale Standard Error 17.79
Change From Baseline in WLQ Scores Month 24 Output Demand	-13.60 units on a scale Standard Error 2.05	-20.77 units on a scale Standard Error 2.08	-16.40 units on a scale Standard Error 3.17

SECONDARY outcome

Timeframe: Baseline and Months 3, 6, and 12

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=199 Participants 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.	CP-690,550 10 mg BID n=215 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=99 Participants 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.
WLQ Work Loss Index Score Baseline	11.00 units on a scale Standard Deviation 5.93	11.21 units on a scale Standard Deviation 6.08	10.55 units on a scale Standard Deviation 6.24
WLQ Work Loss Index Score Month 3	8.05 units on a scale Standard Deviation 6.25	7.60 units on a scale Standard Deviation 6.43	8.32 units on a scale Standard Deviation 5.78
WLQ Work Loss Index Score Month 6	7.72 units on a scale Standard Deviation 5.74	6.49 units on a scale Standard Deviation 5.62	7.29 units on a scale Standard Deviation 5.69
WLQ Work Loss Index Score Month 12	7.89 units on a scale Standard Deviation 6.07	5.88 units on a scale Standard Deviation 5.31	6.47 units on a scale Standard Deviation 5.90

SECONDARY outcome

Timeframe: Months 3, 6, 12, 15, 18, 21, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a specific timepoint for each treatment group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=176 Participants 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.	CP-690,550 10 mg BID n=185 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=83 Participants 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.
Change From Baseline in WLQ Work Loss Index Score Month 3	-2.82 units on a scale Standard Error 0.41	-3.21 units on a scale Standard Error 0.40	-2.03 units on a scale Standard Error 0.59
Change From Baseline in WLQ Work Loss Index Score Month 6	-3.24 units on a scale Standard Error 0.42	-4.23 units on a scale Standard Error 0.41	-3.18 units on a scale Standard Error 0.61
Change From Baseline in WLQ Work Loss Index Score Month 12	-3.35 units on a scale Standard Error 0.44	-4.99 units on a scale Standard Error 0.43	-3.84 units on a scale Standard Error 0.65
Change From Baseline in WLQ Work Loss Index Score Month 15	-7.10 units on a scale Standard Error 4.07	-4.99 units on a scale Standard Error 2.39	-0.19 units on a scale Standard Error 2.43
Change From Baseline in WLQ Work Loss Index Score Month 18	-3.61 units on a scale Standard Error 0.45	-4.90 units on a scale Standard Error 0.45	-3.48 units on a scale Standard Error 0.68
Change From Baseline in WLQ Work Loss Index Score Month 21	-1.14 units on a scale Standard Error 2.33	2.24 units on a scale Standard Error 3.99	-4.92 units on a scale Standard Error 4.00
Change From Baseline in WLQ Work Loss Index Score Month 24	-3.18 units on a scale Standard Error 0.46	-4.96 units on a scale Standard Error 0.46	-4.11 units on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Baseline and Months 3, 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=185 Participants 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.
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score Baseline	0.39 units on a scale Standard Deviation 0.33	0.42 units on a scale Standard Deviation 0.31	0.46 units on a scale Standard Deviation 0.30
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score Month 3	0.67 units on a scale Standard Deviation 0.25	0.69 units on a scale Standard Deviation 0.23	0.63 units on a scale Standard Deviation 0.23
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score Month 6	0.68 units on a scale Standard Deviation 0.23	0.72 units on a scale Standard Deviation 0.22	0.63 units on a scale Standard Deviation 0.26
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score Month 12	0.70 units on a scale Standard Deviation 0.25	0.74 units on a scale Standard Deviation 0.22	0.66 units on a scale Standard Deviation 0.21
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score Month 18	0.73 units on a scale Standard Deviation 0.22	0.75 units on a scale Standard Deviation 0.23	0.66 units on a scale Standard Deviation 0.24
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score Month 24	0.72 units on a scale Standard Deviation 0.24	0.76 units on a scale Standard Deviation 0.22	0.71 units on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: Months 3, 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoints for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=352 Participants 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.	CP-690,550 10 mg BID n=381 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=170 Participants 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.
Change From Baseline in EQ-5D Health State Profile Utility Score Month 3	0.26 units on a scale Standard Error 0.01	0.28 units on a scale Standard Error 0.01	0.21 units on a scale Standard Error 0.02
Change From Baseline in EQ-5D Health State Profile Utility Score Month 6	0.27 units on a scale Standard Error 0.01	0.30 units on a scale Standard Error 0.01	0.20 units on a scale Standard Error 0.02
Change From Baseline in EQ-5D Health State Profile Utility Score Month 12	0.28 units on a scale Standard Error 0.01	0.31 units on a scale Standard Error 0.01	0.23 units on a scale Standard Error 0.02
Change From Baseline in EQ-5D Health State Profile Utility Score Month 18	0.31 units on a scale Standard Error 0.01	0.33 units on a scale Standard Error 0.01	0.23 units on a scale Standard Error 0.02
Change From Baseline in EQ-5D Health State Profile Utility Score Month 24	0.30 units on a scale Standard Error 0.01	0.33 units on a scale Standard Error 0.01	0.28 units on a scale Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline and Months 3 and 6

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=372 Participants 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.	CP-690,550 10 mg BID n=396 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: home healthcare services	1.99 units on a scale Standard Deviation 0.09	1.99 units on a scale Standard Deviation 0.07	2.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: required aids/devices	1.94 units on a scale Standard Deviation 0.24	1.96 units on a scale Standard Deviation 0.19	1.95 units on a scale Standard Deviation 0.22
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: non-medical practitioner	1.99 units on a scale Standard Deviation 0.12	1.99 units on a scale Standard Deviation 0.07	1.97 units on a scale Standard Deviation 0.16
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: currently employed	1.50 units on a scale Standard Deviation 0.50	1.53 units on a scale Standard Deviation 0.50	1.55 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: feel well enough to work	1.55 units on a scale Standard Deviation 0.50	1.57 units on a scale Standard Deviation 0.50	1.65 units on a scale Standard Deviation 0.48
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: unable to work due to RA	1.64 units on a scale Standard Deviation 0.48	1.66 units on a scale Standard Deviation 0.47	1.52 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: lost job/retired early	1.74 units on a scale Standard Deviation 0.44	1.81 units on a scale Standard Deviation 0.40	1.78 units on a scale Standard Deviation 0.42
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: work disabled due to RA	1.68 units on a scale Standard Deviation 0.47	1.70 units on a scale Standard Deviation 0.46	1.68 units on a scale Standard Deviation 0.47
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: retired	1.55 units on a scale Standard Deviation 0.50	1.57 units on a scale Standard Deviation 0.50	1.52 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: sick leave due to RA	1.94 units on a scale Standard Deviation 0.24	1.94 units on a scale Standard Deviation 0.23	1.89 units on a scale Standard Deviation 0.31
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: performed part-time work	1.97 units on a scale Standard Deviation 0.16	1.97 units on a scale Standard Deviation 0.17	1.95 units on a scale Standard Deviation 0.22
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: performed paid work	1.77 units on a scale Standard Deviation 0.42	1.82 units on a scale Standard Deviation 0.38	1.69 units on a scale Standard Deviation 0.46
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: unable to do chores	1.79 units on a scale Standard Deviation 0.41	1.81 units on a scale Standard Deviation 0.40	1.70 units on a scale Standard Deviation 0.46
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: chores by housekeeper	1.96 units on a scale Standard Deviation 0.20	1.94 units on a scale Standard Deviation 0.24	1.94 units on a scale Standard Deviation 0.24
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: chores by family/friends	1.78 units on a scale Standard Deviation 0.41	1.83 units on a scale Standard Deviation 0.37	1.71 units on a scale Standard Deviation 0.46
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: seen any doctor	1.12 units on a scale Standard Deviation 0.33	1.13 units on a scale Standard Deviation 0.33	1.12 units on a scale Standard Deviation 0.32
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: treated in ER	1.95 units on a scale Standard Deviation 0.21	1.91 units on a scale Standard Deviation 0.28	1.91 units on a scale Standard Deviation 0.28
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL:admitted for overnight stay	0.24 units on a scale Standard Deviation 0.56	0.31 units on a scale Standard Deviation 0.83	0.25 units on a scale Standard Deviation 0.58
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: hospitalized	1.89 units on a scale Standard Deviation 0.31	1.93 units on a scale Standard Deviation 0.26	1.88 units on a scale Standard Deviation 0.33
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: any outpatient surgery	1.98 units on a scale Standard Deviation 0.15	1.96 units on a scale Standard Deviation 0.19	1.98 units on a scale Standard Deviation 0.15
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: non-study diagnostic tests	1.74 units on a scale Standard Deviation 0.44	1.74 units on a scale Standard Deviation 0.44	1.69 units on a scale Standard Deviation 0.46
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: in a nursing home	2.00 units on a scale Standard Deviation 0.00	1.99 units on a scale Standard Deviation 0.11	1.98 units on a scale Standard Deviation 0.13
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: home healthcare services	1.99 units on a scale Standard Deviation 0.10	1.99 units on a scale Standard Deviation 0.11	1.98 units on a scale Standard Deviation 0.13
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: used aids/devices	1.90 units on a scale Standard Deviation 0.30	1.91 units on a scale Standard Deviation 0.29	1.91 units on a scale Standard Deviation 0.29
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: non-medical practitioner	1.97 units on a scale Standard Deviation 0.17	1.96 units on a scale Standard Deviation 0.20	1.96 units on a scale Standard Deviation 0.19
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: currently employed	1.55 units on a scale Standard Deviation 0.50	1.53 units on a scale Standard Deviation 0.50	1.54 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: feel well enough to work	1.78 units on a scale Standard Deviation 0.42	1.78 units on a scale Standard Deviation 0.42	1.78 units on a scale Standard Deviation 0.42
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: unable to work due to RA	1.45 units on a scale Standard Deviation 0.50	1.49 units on a scale Standard Deviation 0.50	1.42 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: Lost job/retired early	1.75 units on a scale Standard Deviation 0.44	1.81 units on a scale Standard Deviation 0.40	1.77 units on a scale Standard Deviation 0.43
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: work disabled due to RA	1.55 units on a scale Standard Deviation 0.50	1.58 units on a scale Standard Deviation 0.50	1.59 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: retired	1.60 units on a scale Standard Deviation 0.49	1.61 units on a scale Standard Deviation 0.49	1.53 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: sick leave due to RA	1.74 units on a scale Standard Deviation 0.44	1.73 units on a scale Standard Deviation 0.45	1.74 units on a scale Standard Deviation 0.44
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: performed part time work	1.90 units on a scale Standard Deviation 0.30	1.88 units on a scale Standard Deviation 0.33	1.83 units on a scale Standard Deviation 0.38
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: performed paid work	1.61 units on a scale Standard Deviation 0.49	1.57 units on a scale Standard Deviation 0.50	1.57 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: unable to do chores	1.41 units on a scale Standard Deviation 0.49	1.40 units on a scale Standard Deviation 0.49	1.44 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: chores by housekeeper	1.91 units on a scale Standard Deviation 0.29	1.87 units on a scale Standard Deviation 0.33	1.93 units on a scale Standard Deviation 0.26
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 BL: chores by family/friends	1.48 units on a scale Standard Deviation 0.50	1.50 units on a scale Standard Deviation 0.50	1.49 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: seen any doctor	1.36 units on a scale Standard Deviation 0.48	1.30 units on a scale Standard Deviation 0.46	1.30 units on a scale Standard Deviation 0.46
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: treated in ER	1.97 units on a scale Standard Deviation 0.18	1.96 units on a scale Standard Deviation 0.20	1.98 units on a scale Standard Deviation 0.13
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3:admitted for overnight stay	0.08 units on a scale Standard Deviation 0.29	0.06 units on a scale Standard Deviation 0.25	0.33 units on a scale Standard Deviation 0.58
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3:hospitalization	1.99 units on a scale Standard Deviation 0.11	1.99 units on a scale Standard Deviation 0.09	1.99 units on a scale Standard Deviation 0.11
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: outpatient surgery	1.99 units on a scale Standard Deviation 0.12	1.98 units on a scale Standard Deviation 0.13	1.99 units on a scale Standard Deviation 0.11
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: non-study diagnostic tests	1.90 units on a scale Standard Deviation 0.30	1.90 units on a scale Standard Deviation 0.31	1.92 units on a scale Standard Deviation 0.27
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: in nursing home	2.00 units on a scale Standard Deviation 0.05	1.99 units on a scale Standard Deviation 0.09	2.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: home healthcare services	2.00 units on a scale Standard Deviation 0.05	1.99 units on a scale Standard Deviation 0.10	2.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: required aids/devices	1.94 units on a scale Standard Deviation 0.23	1.95 units on a scale Standard Deviation 0.22	1.92 units on a scale Standard Deviation 0.27
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: non-medical practitioner	1.98 units on a scale Standard Deviation 0.14	1.98 units on a scale Standard Deviation 0.12	1.99 units on a scale Standard Deviation 0.11
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: currently employed	1.51 units on a scale Standard Deviation 0.50	1.53 units on a scale Standard Deviation 0.50	1.53 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: feel well enough to work	1.62 units on a scale Standard Deviation 0.49	1.58 units on a scale Standard Deviation 0.50	1.67 units on a scale Standard Deviation 0.47
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: unable to work due to RA	1.56 units on a scale Standard Deviation 0.50	1.64 units on a scale Standard Deviation 0.48	1.50 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: lost job/retired early	1.70 units on a scale Standard Deviation 0.46	1.79 units on a scale Standard Deviation 0.41	1.83 units on a scale Standard Deviation 0.38
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: work disabled due to RA	1.64 units on a scale Standard Deviation 0.48	1.68 units on a scale Standard Deviation 0.47	1.67 units on a scale Standard Deviation 0.47
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: retired	1.56 units on a scale Standard Deviation 0.50	1.59 units on a scale Standard Deviation 0.49	1.54 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: sick leave due to RA	1.87 units on a scale Standard Deviation 0.33	1.90 units on a scale Standard Deviation 0.31	1.85 units on a scale Standard Deviation 0.36
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: performed part-time work	1.93 units on a scale Standard Deviation 0.25	1.95 units on a scale Standard Deviation 0.21	1.92 units on a scale Standard Deviation 0.27
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: performed paid work	1.69 units on a scale Standard Deviation 0.46	1.72 units on a scale Standard Deviation 0.45	1.66 units on a scale Standard Deviation 0.47
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: unable to do chores	1.69 units on a scale Standard Deviation 0.46	1.71 units on a scale Standard Deviation 0.45	1.54 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: chores by housekeeper	1.95 units on a scale Standard Deviation 0.22	1.92 units on a scale Standard Deviation 0.27	1.89 units on a scale Standard Deviation 0.31
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 3: chores by family/friends	1.70 units on a scale Standard Deviation 0.46	1.71 units on a scale Standard Deviation 0.45	1.58 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: seen any doctor	1.40 units on a scale Standard Deviation 0.49	1.39 units on a scale Standard Deviation 0.49	1.35 units on a scale Standard Deviation 0.48
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: treated in ER	1.96 units on a scale Standard Deviation 0.20	1.95 units on a scale Standard Deviation 0.22	1.98 units on a scale Standard Deviation 0.14
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6:admitted for overnight stay	0.36 units on a scale Standard Deviation 0.74	0.21 units on a scale Standard Deviation 0.54	1.33 units on a scale Standard Deviation 1.15
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: Hospitalization	1.99 units on a scale Standard Deviation 0.09	1.98 units on a scale Standard Deviation 0.14	1.97 units on a scale Standard Deviation 0.16
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: outpatient surgery	1.98 units on a scale Standard Deviation 0.13	1.98 units on a scale Standard Deviation 0.14	1.97 units on a scale Standard Deviation 0.16
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: non-study diagnostic test	1.91 units on a scale Standard Deviation 0.29	1.88 units on a scale Standard Deviation 0.32	1.89 units on a scale Standard Deviation 0.31
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Month 6: in nursing home	2.00 units on a scale Standard Deviation 0.05	2.00 units on a scale Standard Deviation 0.05	1.99 units on a scale Standard Deviation 0.08

SECONDARY outcome

Timeframe: Months 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

Outcome measures

SECONDARY outcome

Timeframe: Baseline and Months 3 and 6

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=326 Participants 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.	CP-690,550 10 mg BID n=345 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=165 Participants 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.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: doctor visits	4.81 events Standard Deviation 5.57	4.37 events Standard Deviation 3.86	4.82 events Standard Deviation 5.31
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: RA-related doctor visits	1.55 events Standard Deviation 1.07	1.46 events Standard Deviation 0.95	1.56 events Standard Deviation 0.96
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: hospital ER visit	2.13 events Standard Deviation 2.73	1.49 events Standard Deviation 0.98	1.38 events Standard Deviation 0.65
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: RA-related ER visits	1.12 events Standard Deviation 0.86	1.00 events Standard Deviation 0.83	1.13 events Standard Deviation 1.02
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: hospitalization	1.03 events Standard Deviation 0.16	1.00 events Standard Deviation 0.00	1.05 events Standard Deviation 0.21
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: RA-related hospitalization	1.27 events Standard Deviation 0.55	1.24 events Standard Deviation 0.69	1.13 events Standard Deviation 0.55
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: outpatient surgery	2.56 events Standard Deviation 3.24	2.13 events Standard Deviation 2.61	1.25 events Standard Deviation 0.50
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: RA-related outpatient surgery	0.33 events Standard Deviation 0.50	0.80 events Standard Deviation 0.86	0.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL:non-study diagnostic tests	2.25 events Standard Deviation 1.60	2.05 events Standard Deviation 1.27	1.75 events Standard Deviation 1.18
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: RA-related diagnostic tests	1.20 events Standard Deviation 1.22	1.21 events Standard Deviation 1.21	1.09 events Standard Deviation 0.91
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: non-medical practitioner visits	23.82 events Standard Deviation 56.10	10.07 events Standard Deviation 19.72	8.57 events Standard Deviation 11.13
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: RA-related non-medical visits	1.00 events Standard Deviation 0.82	1.13 events Standard Deviation 0.81	1.14 events Standard Deviation 0.69
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: doctor visits	3.45 events Standard Deviation 2.99	3.44 events Standard Deviation 3.12	3.57 events Standard Deviation 2.94
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: RA-related doctor visits	0.99 events Standard Deviation 0.77	0.96 events Standard Deviation 0.62	1.03 events Standard Deviation 0.72
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: hospital ER visits	1.83 events Standard Deviation 1.34	1.94 events Standard Deviation 2.08	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: RA-related ER visits	0.33 events Standard Deviation 0.65	0.13 events Standard Deviation 0.34	0.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: hospitalization	1.00 events Standard Deviation 0.00	1.00 events Standard Deviation 0.00	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: RA-related hospitalization	0.25 events Standard Deviation 0.50	0.33 events Standard Deviation 0.58	0.50 events Standard Deviation 0.71
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: outpatient surgery	1.25 events Standard Deviation 0.50	1.00 events Standard Deviation 0.00	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3:RA-related outpatient surgery	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: non-study diagnostic tests	1.32 events Standard Deviation 0.64	1.33 events Standard Deviation 0.73	1.57 events Standard Deviation 1.02
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: RA-related diagnostic tests	0.18 events Standard Deviation 0.39	0.27 events Standard Deviation 0.50	0.21 events Standard Deviation 0.80
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3:non-medical practitioner visits	10.33 events Standard Deviation 15.13	4.50 events Standard Deviation 2.43	9.00 events Standard Deviation 7.07
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3:RA-related non-medical visits	0.67 events Standard Deviation 0.82	1.00 events Standard Deviation 0.63	2.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: doctor visits	2.57 events Standard Deviation 3.64	2.48 events Standard Deviation 2.82	2.12 events Standard Deviation 1.72
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: RA-related doctor visits	0.82 events Standard Deviation 0.72	0.74 events Standard Deviation 0.64	0.74 events Standard Deviation 0.54
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: hospital ER visits	1.36 events Standard Deviation 0.84	1.22 events Standard Deviation 0.73	5.33 events Standard Deviation 5.86
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: RA-related ER visits	0.07 events Standard Deviation 0.26	0.26 events Standard Deviation 0.65	1.00 events Standard Deviation 1.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: hospitalization	1.00 events Standard Deviation 0.00	2.29 events Standard Deviation 3.40	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: RA-related hospitalization	0.00 events Standard Deviation 0.00	0.14 events Standard Deviation 0.38	0.75 events Standard Deviation 0.96
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: outpatient surgery	1.50 events Standard Deviation 1.22	1.43 events Standard Deviation 0.79	1.25 events Standard Deviation 0.50
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6:RA-related outpatient surgery	0.00 events Standard Deviation 0.00	0.14 events Standard Deviation 0.38	0.25 events Standard Deviation 0.50
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: non-study diagnostic tests	1.73 events Standard Deviation 1.39	1.54 events Standard Deviation 1.00	1.47 events Standard Deviation 0.94
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: RA related diagnostic tests	0.26 events Standard Deviation 0.63	0.12 events Standard Deviation 0.40	0.35 events Standard Deviation 0.79
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6:non-medical practitioner visits	10.40 events Standard Deviation 14.05	5.50 events Standard Deviation 6.36	4.75 events Standard Deviation 1.26
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6:RA-related non-medical visits	1.20 events Standard Deviation 1.30	1.50 events Standard Deviation 0.71	1.25 events Standard Deviation 1.26

SECONDARY outcome

Timeframe: Months 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=173 Participants 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.	CP-690,550 10 mg BID n=185 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=79 Participants 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.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: doctor visit	2.19 events Standard Deviation 1.81	2.19 events Standard Deviation 1.72	2.22 events Standard Deviation 1.62
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related doctor visit	0.77 events Standard Deviation 0.61	0.74 events Standard Deviation 0.70	0.89 events Standard Deviation 0.77
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: hospital ER visit	1.06 events Standard Deviation 0.25	1.13 events Standard Deviation 0.35	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related ER visit	0.13 events Standard Deviation 0.50	0.00 events Standard Deviation 0.00	0.20 events Standard Deviation 0.45
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: hospitalization	1.00 events Standard Deviation 0.00	1.00 events Standard Deviation 0.00	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related hospitalization	0.29 events Standard Deviation 0.49	0.00 events Standard Deviation 0.00	0.50 events Standard Deviation 0.71
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: outpatient surgery	1.00 events Standard Deviation 0.00	1.50 events Standard Deviation 1.07	1.33 events Standard Deviation 0.58
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related outpatient surgery	0.11 events Standard Deviation 0.33	0.13 events Standard Deviation 0.35	0.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:non-study diagnostic tests	1.61 events Standard Deviation 1.05	1.34 events Standard Deviation 0.57	1.18 events Standard Deviation 0.40
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related diagnostic tests	0.13 events Standard Deviation 0.50	0.22 events Standard Deviation 0.57	0.36 events Standard Deviation 0.67
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:non-medical practitioner visits	17.00 events Standard Deviation 18.38	13.33 events Standard Deviation 6.43	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:RA-related non-medical visits	1.00 events Standard Deviation 1.41	1.33 events Standard Deviation 1.15	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: doctor visits	2.17 events Standard Deviation 1.91	2.21 events Standard Deviation 1.83	2.93 events Standard Deviation 3.02
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: RA-related doctor visit	0.78 events Standard Deviation 0.74	0.82 events Standard Deviation 0.66	0.80 events Standard Deviation 0.65
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: hospital ER visit	1.60 events Standard Deviation 1.35	1.89 events Standard Deviation 1.36	1.40 events Standard Deviation 0.89
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: RA-related ER visit	0.20 events Standard Deviation 0.63	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: hospitalization	2.33 events Standard Deviation 2.31	1.00 events Standard Deviation 0.00	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:RA-related hospitalization	0.00 events Standard Deviation 0.00	0.67 events Standard Deviation 1.03	0.67 events Standard Deviation 1.15
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: outpatient surgery	1.00 events Standard Deviation 0.00	2.14 events Standard Deviation 1.68	3.00 events Standard Deviation 2.65
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:RA-related outpatient surgery	0.33 events Standard Deviation 0.82	0.14 events Standard Deviation 0.38	0.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:non-study diagnostic tests	1.48 events Standard Deviation 0.77	1.85 events Standard Deviation 1.43	1.50 events Standard Deviation 0.80
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:RA-related diagnostic tests	0.08 events Standard Deviation 0.39	0.19 events Standard Deviation 0.49	0.08 events Standard Deviation 0.29
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:non-medical practitioner visits	16.00 events Standard Deviation 19.80	18.00 events Standard Deviation 16.25	4.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:RA-related non-medical visits	2.00 events Standard Deviation 0.00	1.50 events Standard Deviation 1.91	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: doctor visits	2.27 events Standard Deviation 2.17	2.78 events Standard Deviation 3.80	2.75 events Standard Deviation 2.03
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: RA-related doctor visits	0.83 events Standard Deviation 0.60	0.76 events Standard Deviation 0.71	0.93 events Standard Deviation 0.80
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24 hospital ER visits	1.40 events Standard Deviation 0.70	1.33 events Standard Deviation 0.65	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: RA-related ER visits	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00	1.33 events Standard Deviation 1.15
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: hospitalization	1.00 events Standard Deviation 0.00	1.25 events Standard Deviation 0.50	1.50 events Standard Deviation 0.71
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:RA-related hospitalization	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: outpatient surgery	3.25 events Standard Deviation 4.50	2.00 events Standard Deviation 2.24	3.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:RA-related outpatient surgery	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00	2.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:non-study diagnostic tests	1.50 events Standard Deviation 0.83	1.29 events Standard Deviation 0.53	1.40 events Standard Deviation 0.51
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:RA related diagnostic tests	0.11 events Standard Deviation 0.32	0.03 events Standard Deviation 0.18	0.27 events Standard Deviation 0.59
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:non-medical practitioner visits	20.67 events Standard Deviation 3.06	3.50 events Standard Deviation 1.91	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:RA-related non-medical visits	0.67 events Standard Deviation 1.15	1.00 events Standard Deviation 1.15	—

SECONDARY outcome

Timeframe: Baseline and Months 3 and 6

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=190 Participants 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.	CP-690,550 10 mg BID n=196 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=94 Participants 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.
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: paid work, bothered by RA	21.04 days Standard Deviation 26.24	19.48 days Standard Deviation 25.23	22.13 days Standard Deviation 28.03
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: hospital length of stay	19.07 days Standard Deviation 10.86	23.76 days Standard Deviation 18.95	15.45 days Standard Deviation 11.61
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: days in nursing home	—	30.60 days Standard Deviation 33.62	41.67 days Standard Deviation 42.00
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: days aids/devices used	99.94 days Standard Deviation 107.83	93.06 days Standard Deviation 130.53	162.88 days Standard Deviation 140.39
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: RA-related aids used	1.61 days Standard Deviation 1.15	1.75 days Standard Deviation 1.36	2.24 days Standard Deviation 1.95
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: days of work per week	5.11 days Standard Deviation 0.98	4.96 days Standard Deviation 0.97	5.12 days Standard Deviation 0.91
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: days on sick leave due to RA	23.52 days Standard Deviation 25.55	16.59 days Standard Deviation 22.38	27.67 days Standard Deviation 30.63
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: days of part-time work	11.94 days Standard Deviation 20.56	12.12 days Standard Deviation 18.10	11.39 days Standard Deviation 14.06
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: paid work, bothered by RA	35.69 days Standard Deviation 30.24	38.54 days Standard Deviation 47.28	31.68 days Standard Deviation 30.31
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: chores by housekeeper	19.56 days Standard Deviation 27.62	25.46 days Standard Deviation 33.29	21.25 days Standard Deviation 32.37
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: chores by family	32.35 days Standard Deviation 34.46	34.13 days Standard Deviation 34.19	34.35 days Standard Deviation 33.04
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: hospital length of stay	14.25 days Standard Deviation 17.19	7.00 days Standard Deviation 7.21	20.00 days Standard Deviation 1.41
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: days in nursing home	28.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	43.33 days Standard Deviation 40.43	—
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: days aids/devices used	109.00 days Standard Deviation 116.27	123.85 days Standard Deviation 76.69	105.86 days Standard Deviation 77.06
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: RA-related aids used	1.45 days Standard Deviation 1.23	1.75 days Standard Deviation 0.55	1.71 days Standard Deviation 0.91
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: days of work per week	5.16 days Standard Deviation 1.06	4.99 days Standard Deviation 1.02	5.08 days Standard Deviation 0.80
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3:days on sick leave due to RA	20.76 days Standard Deviation 30.15	26.97 days Standard Deviation 34.53	36.61 days Standard Deviation 37.92
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: days of part time work	14.85 days Standard Deviation 25.99	29.67 days Standard Deviation 38.10	16.17 days Standard Deviation 25.29
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: chores by housekeeper	22.53 days Standard Deviation 30.49	21.43 days Standard Deviation 28.45	17.33 days Standard Deviation 28.24
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: chores by family	23.13 days Standard Deviation 29.61	21.06 days Standard Deviation 27.81	24.80 days Standard Deviation 28.39
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: hospital length of stay	9.33 days Standard Deviation 5.03	9.00 days Standard Deviation 13.62	10.75 days Standard Deviation 9.00
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: days in nursing home	14.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	90.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	61.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: days aids/devices used	74.15 days Standard Deviation 65.25	159.08 days Standard Deviation 138.46	190.25 days Standard Deviation 93.12
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: RA-related aids used	1.25 days Standard Deviation 0.55	2.00 days Standard Deviation 1.36	2.38 days Standard Deviation 0.74
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: days of work per week	5.11 days Standard Deviation 0.95	4.93 days Standard Deviation 1.05	5.10 days Standard Deviation 0.99
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6:days on sick leave due to RA	18.00 days Standard Deviation 19.68	21.94 days Standard Deviation 33.32	40.07 days Standard Deviation 41.32
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: days of part time work	14.13 days Standard Deviation 14.71	7.11 days Standard Deviation 5.49	11.71 days Standard Deviation 21.31
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: paid work, bothered by RA	26.23 days Standard Deviation 30.00	16.41 days Standard Deviation 23.15	24.49 days Standard Deviation 28.36
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: chores by housekeeper	21.57 days Standard Deviation 29.10	20.57 days Standard Deviation 28.22	13.80 days Standard Deviation 27.20
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: chores by family	23.62 days Standard Deviation 29.77	20.05 days Standard Deviation 26.35	22.09 days Standard Deviation 28.50

SECONDARY outcome

Timeframe: Months 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=154 Participants 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.	CP-690,550 10 mg BID n=153 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=64 Participants 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.
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: hospital length of stay	10.43 days Standard Deviation 8.62	9.25 days Standard Deviation 3.59	9.00 days Standard Deviation 8.49
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: days in nursing home	—	54.00 days Standard Deviation 50.91	20.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: days aids/devices used	118.05 days Standard Deviation 99.31	231.00 days Standard Deviation 190.27	65.75 days Standard Deviation 16.50
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related aids used	1.50 days Standard Deviation 0.83	1.89 days Standard Deviation 1.96	1.50 days Standard Deviation 0.58
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: days of work per week	5.14 days Standard Deviation 0.98	4.95 days Standard Deviation 1.01	5.05 days Standard Deviation 0.93
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:days on sick leave due to RA	17.47 days Standard Deviation 28.41	10.14 days Standard Deviation 9.94	2.75 days Standard Deviation 1.49
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: days of part-time work	5.56 days Standard Deviation 6.82	12.17 days Standard Deviation 10.11	16.00 days Standard Deviation 15.56
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:paid work, bothered by RA	19.31 days Standard Deviation 21.34	16.23 days Standard Deviation 22.36	21.10 days Standard Deviation 26.11
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: chores by housekeeper	13.09 days Standard Deviation 25.89	24.36 days Standard Deviation 35.96	7.40 days Standard Deviation 3.58
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: chores by family	22.04 days Standard Deviation 30.72	20.11 days Standard Deviation 27.19	17.74 days Standard Deviation 25.33
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: hospital length of stay	6.67 days Standard Deviation 3.06	13.67 days Standard Deviation 9.42	33.33 days Standard Deviation 11.55
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: days in nursing home	15.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—	—
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: days aids/devices used	126.67 days Standard Deviation 125.26	169.50 days Standard Deviation 157.29	159.50 days Standard Deviation 41.00
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: RA-related aids used	2.25 days Standard Deviation 1.06	2.25 days Standard Deviation 1.67	2.50 days Standard Deviation 1.00
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: days of work per week	5.13 days Standard Deviation 1.00	5.01 days Standard Deviation 0.99	5.00 days Standard Deviation 0.69
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:days on sick leave due to RA	16.93 days Standard Deviation 23.97	6.09 days Standard Deviation 5.87	4.20 days Standard Deviation 1.64
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: days of part time work	4.33 days Standard Deviation 3.01	6.80 days Standard Deviation 4.66	31.00 days Standard Deviation 41.01
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:paid work, bothered by RA	16.82 days Standard Deviation 22.67	16.30 days Standard Deviation 22.60	19.35 days Standard Deviation 25.33
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: chores by housekeeper	9.40 days Standard Deviation 6.99	21.75 days Standard Deviation 33.15	3.83 days Standard Deviation 2.48
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: chores by family	20.49 days Standard Deviation 29.77	21.30 days Standard Deviation 30.38	27.37 days Standard Deviation 35.36
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: hospital length of stay	5.33 days Standard Deviation 5.77	21.00 days Standard Deviation 10.65	6.00 days Standard Deviation 2.83
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: days in nursing home	2.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	21.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	15.50 days Standard Deviation 7.78
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: days aids/devices used	137.85 days Standard Deviation 150.03	178.20 days Standard Deviation 178.98	136.50 days Standard Deviation 87.00
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: RA-related aids used	2.15 days Standard Deviation 1.52	1.82 days Standard Deviation 2.09	1.50 days Standard Deviation 1.00
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: days of work per week	5.10 days Standard Deviation 1.02	5.03 days Standard Deviation 1.01	5.15 days Standard Deviation 0.80
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:days on sick leave due to RA	19.33 days Standard Deviation 27.95	3.25 days Standard Deviation 2.50	7.25 days Standard Deviation 12.46
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: days of part time work	6.60 days Standard Deviation 4.10	3.00 days Standard Deviation 2.83	19.00 days Standard Deviation 30.69
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: paid work, bothered by RA	21.95 days Standard Deviation 27.30	9.17 days Standard Deviation 9.50	16.95 days Standard Deviation 17.31
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: chores by housekeeper	6.90 days Standard Deviation 8.28	4.75 days Standard Deviation 2.99	4.00 days Standard Deviation 2.00
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: chores by family	16.65 days Standard Deviation 23.82	12.18 days Standard Deviation 21.46	17.21 days Standard Deviation 26.87

SECONDARY outcome

Timeframe: Baseline and Months 3 and 6

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=191 Participants 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.	CP-690,550 10 mg BID n=195 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=92 Participants 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.
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: home healthcare services	1.50 hours per day Standard Deviation 0.58	2.20 hours per day Standard Deviation 1.64	1.00 hours per day Standard Deviation 1.00
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: RA-related home HC services	1.00 hours per day Standard Deviation 0.82	0.83 hours per day Standard Deviation 0.75	1.33 hours per day Standard Deviation 0.58
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: work done	8.53 hours per day Standard Deviation 5.33	8.25 hours per day Standard Deviation 4.02	7.68 hours per day Standard Deviation 1.81
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: missed work due to RA	4.36 hours per day Standard Deviation 4.98	5.62 hours per day Standard Deviation 13.58	6.21 hours per day Standard Deviation 8.96
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: chores by housekeeper	4.85 hours per day Standard Deviation 2.31	6.46 hours per day Standard Deviation 9.83	4.75 hours per day Standard Deviation 2.45
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 BL: chores by family	4.26 hours per day Standard Deviation 4.56	3.92 hours per day Standard Deviation 4.23	4.08 hours per day Standard Deviation 4.01
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: home healthcare services	0.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	1.25 hours per day Standard Deviation 0.50	—
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3:RA-related home HC services	0.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	0.25 hours per day Standard Deviation 0.50	—
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: work done	8.53 hours per day Standard Deviation 4.70	8.55 hours per day Standard Deviation 5.23	8.33 hours per day Standard Deviation 3.71
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: missed work due to RA	4.11 hours per day Standard Deviation 2.51	8.86 hours per day Standard Deviation 15.72	5.58 hours per day Standard Deviation 7.95
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: chores by housekeeper	4.50 hours per day Standard Deviation 2.43	5.40 hours per day Standard Deviation 4.61	4.00 hours per day Standard Deviation 2.55
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 3: chores by family	3.44 hours per day Standard Deviation 3.77	3.35 hours per day Standard Deviation 3.50	3.61 hours per day Standard Deviation 4.19
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: home healthcare services	5.00 hours per day Standard Deviation 6.08	4.50 hours per day Standard Deviation 0.71	—
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: RA-related home HC services	0.67 hours per day Standard Deviation 0.58	2.00 hours per day Standard Deviation 2.83	—
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: work done	7.97 hours per day Standard Deviation 2.84	8.29 hours per day Standard Deviation 4.40	7.85 hours per day Standard Deviation 1.47
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: missed work due to RA	4.14 hours per day Standard Deviation 2.67	4.11 hours per day Standard Deviation 3.44	6.33 hours per day Standard Deviation 5.75
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: chores by housekeeper	4.93 hours per day Standard Deviation 2.70	5.17 hours per day Standard Deviation 2.92	4.80 hours per day Standard Deviation 2.20
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Month 6: chores by family	3.86 hours per day Standard Deviation 2.84	3.28 hours per day Standard Deviation 2.29	4.22 hours per day Standard Deviation 6.14

SECONDARY outcome

Timeframe: Months 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=154 Participants 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.	CP-690,550 10 mg BID n=153 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=64 Participants 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.
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: home healthcare services	2.00 hours per day Standard Deviation 0.00	25.00 hours per day Standard Deviation 32.53	—
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:RA-related home HC services	0.00 hours per day Standard Deviation 0.00	0.00 hours per day Standard Deviation 0.00	—
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: work done	8.38 hours per day Standard Deviation 3.90	7.99 hours per day Standard Deviation 3.59	8.34 hours per day Standard Deviation 4.32
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: missed work due to RA	2.25 hours per day Standard Deviation 1.28	4.83 hours per day Standard Deviation 5.34	3.50 hours per day Standard Deviation 0.71
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: chores by housekeeper	6.64 hours per day Standard Deviation 4.67	4.60 hours per day Standard Deviation 2.29	3.80 hours per day Standard Deviation 1.92
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: chores by family	3.44 hours per day Standard Deviation 3.66	3.29 hours per day Standard Deviation 2.40	3.19 hours per day Standard Deviation 2.25
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: home healthcare services	2.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—	—
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:RA-related home HC services	0.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—	—
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: work done	8.18 hours per day Standard Deviation 3.73	8.32 hours per day Standard Deviation 4.16	8.02 hours per day Standard Deviation 1.45
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: missed work due to RA	3.00 hours per day Standard Deviation 2.53	1.80 hours per day Standard Deviation 1.64	2.50 hours per day Standard Deviation 0.71
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: chores by housekeeper	5.60 hours per day Standard Deviation 1.34	4.92 hours per day Standard Deviation 2.94	4.33 hours per day Standard Deviation 3.01
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: chores by family	3.74 hours per day Standard Deviation 4.42	3.70 hours per day Standard Deviation 3.28	3.44 hours per day Standard Deviation 2.57
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:home healthcare services	—	2.67 hours per day Standard Deviation 1.15	2.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: RA-related home HC services	—	0.00 hours per day Standard Deviation 0.00	2.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: work done	8.63 hours per day Standard Deviation 4.69	7.84 hours per day Standard Deviation 2.36	8.02 hours per day Standard Deviation 1.48
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: missed work due to RA	6.50 hours per day Standard Deviation 6.61	2.00 hours per day Standard Deviation 0.00	4.50 hours per day Standard Deviation 7.72
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: chores by housekeeper	8.50 hours per day Standard Deviation 8.63	5.25 hours per day Standard Deviation 2.93	4.33 hours per day Standard Deviation 0.58
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: chores by family	2.97 hours per day Standard Deviation 2.14	2.81 hours per day Standard Deviation 2.22	3.75 hours per day Standard Deviation 3.19

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=276 Participants 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.	CP-690,550 10 mg BID n=292 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=138 Participants 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.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Baseline	4.94 units on a scale Standard Deviation 3.26	4.71 units on a scale Standard Deviation 3.07	4.57 units on a scale Standard Deviation 3.15
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 3	3.59 units on a scale Standard Deviation 2.92	3.25 units on a scale Standard Deviation 3.78	3.57 units on a scale Standard Deviation 2.80
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 6	2.97 units on a scale Standard Deviation 3.58	2.27 units on a scale Standard Deviation 2.58	3.04 units on a scale Standard Deviation 2.75
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 12	2.69 units on a scale Standard Deviation 2.75	2.08 units on a scale Standard Deviation 2.38	2.94 units on a scale Standard Deviation 3.85
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 18	2.33 units on a scale Standard Deviation 2.63	2.11 units on a scale Standard Deviation 2.47	2.11 units on a scale Standard Deviation 2.38
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 24	2.47 units on a scale Standard Deviation 2.63	2.35 units on a scale Standard Deviation 2.75	2.52 units on a scale Standard Deviation 2.68

SECONDARY outcome

Timeframe: Months 3 and 6

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=351 Participants 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.	CP-690,550 10 mg BID n=381 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=171 Participants 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.
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: seen any doctor	0.24 units on a scale Standard Deviation 0.49	0.18 units on a scale Standard Deviation 0.48	0.18 units on a scale Standard Deviation 0.46
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: treated in ER	0.01 units on a scale Standard Deviation 0.25	0.04 units on a scale Standard Deviation 0.32	0.06 units on a scale Standard Deviation 0.31
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3:admitted for overnight stay	0.00 units on a scale Standard Deviation 0.00	-0.60 units on a scale Standard Deviation 0.89	—
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3:hospitalization	0.10 units on a scale Standard Deviation 0.33	0.07 units on a scale Standard Deviation 0.26	0.12 units on a scale Standard Deviation 0.36
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: outpatient surgery	0.01 units on a scale Standard Deviation 0.19	0.02 units on a scale Standard Deviation 0.24	0.01 units on a scale Standard Deviation 0.17
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: non-study diagnostic test	0.16 units on a scale Standard Deviation 0.51	0.17 units on a scale Standard Deviation 0.47	0.23 units on a scale Standard Deviation 0.50
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: in nursing home	-0.00 units on a scale Standard Deviation 0.05	0.00 units on a scale Standard Deviation 0.11	0.02 units on a scale Standard Deviation 0.13
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: home healthcare services	0.01 units on a scale Standard Deviation 0.12	0.00 units on a scale Standard Deviation 0.11	0.02 units on a scale Standard Deviation 0.13
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: required aids/devices	0.05 units on a scale Standard Deviation 0.29	0.04 units on a scale Standard Deviation 0.27	-0.01 units on a scale Standard Deviation 0.25
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: non-medical practitioner	0.01 units on a scale Standard Deviation 0.18	0.03 units on a scale Standard Deviation 0.20	0.03 units on a scale Standard Deviation 0.20
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: currently employed	-0.03 units on a scale Standard Deviation 0.26	-0.00 units on a scale Standard Deviation 0.27	0.00 units on a scale Standard Deviation 0.27
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: feel well enough to work	-0.16 units on a scale Standard Deviation 0.46	-0.17 units on a scale Standard Deviation 0.45	-0.11 units on a scale Standard Deviation 0.45
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: unable to work due to RA	0.12 units on a scale Standard Deviation 0.44	0.13 units on a scale Standard Deviation 0.52	0.05 units on a scale Standard Deviation 0.55
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: lost job/retired early	-0.07 units on a scale Standard Deviation 0.47	-0.02 units on a scale Standard Deviation 0.38	0.05 units on a scale Standard Deviation 0.45
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: work disabled due to RA	0.10 units on a scale Standard Deviation 0.42	0.11 units on a scale Standard Deviation 0.49	0.06 units on a scale Standard Deviation 0.43
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: retired	-0.01 units on a scale Standard Deviation 0.24	-0.02 units on a scale Standard Deviation 0.28	0.01 units on a scale Standard Deviation 0.33
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: sick leave due to RA	0.14 units on a scale Standard Deviation 0.42	0.18 units on a scale Standard Deviation 0.45	0.13 units on a scale Standard Deviation 0.44
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: performed part-time work	0.04 units on a scale Standard Deviation 0.31	0.08 units on a scale Standard Deviation 0.36	0.09 units on a scale Standard Deviation 0.41
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: performed paid work	0.09 units on a scale Standard Deviation 0.48	0.16 units on a scale Standard Deviation 0.51	0.12 units on a scale Standard Deviation 0.46
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: unable to do chores	0.28 units on a scale Standard Deviation 0.57	0.32 units on a scale Standard Deviation 0.54	0.09 units on a scale Standard Deviation 0.53
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: chores by housekeeper	0.04 units on a scale Standard Deviation 0.29	0.05 units on a scale Standard Deviation 0.29	-0.04 units on a scale Standard Deviation 0.29
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 3: chores by family/friends	0.21 units on a scale Standard Deviation 0.53	0.21 units on a scale Standard Deviation 0.49	0.09 units on a scale Standard Deviation 0.53
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: seen any doctor	0.28 units on a scale Standard Deviation 0.53	0.26 units on a scale Standard Deviation 0.50	0.22 units on a scale Standard Deviation 0.47
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: treated in ER	0.00 units on a scale Standard Deviation 0.29	0.03 units on a scale Standard Deviation 0.33	0.05 units on a scale Standard Deviation 0.29
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6:admitted for overnight stay	—	-0.20 units on a scale Standard Deviation 0.45	—
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: Hospitalization	0.10 units on a scale Standard Deviation 0.33	0.06 units on a scale Standard Deviation 0.29	0.09 units on a scale Standard Deviation 0.35
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: outpatient surgery	0.01 units on a scale Standard Deviation 0.21	0.02 units on a scale Standard Deviation 0.24	-0.01 units on a scale Standard Deviation 0.21
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: non-study diagnostic test	0.17 units on a scale Standard Deviation 0.54	0.15 units on a scale Standard Deviation 0.52	0.18 units on a scale Standard Deviation 0.54
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: in nursing home	-0.00 units on a scale Standard Deviation 0.05	0.01 units on a scale Standard Deviation 0.09	0.01 units on a scale Standard Deviation 0.14
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: home healthcare services	0.00 units on a scale Standard Deviation 0.14	0.01 units on a scale Standard Deviation 0.14	0.01 units on a scale Standard Deviation 0.11
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: required aids/devices	0.04 units on a scale Standard Deviation 0.28	0.05 units on a scale Standard Deviation 0.29	0.04 units on a scale Standard Deviation 0.27
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: non-medical practitioner	0.01 units on a scale Standard Deviation 0.18	0.04 units on a scale Standard Deviation 0.20	0.00 units on a scale Standard Deviation 0.20
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: currently employed	-0.04 units on a scale Standard Deviation 0.28	-0.01 units on a scale Standard Deviation 0.27	0.00 units on a scale Standard Deviation 0.28
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: feel well enough to work	-0.24 units on a scale Standard Deviation 0.55	-0.19 units on a scale Standard Deviation 0.45	-0.10 units on a scale Standard Deviation 0.53
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: unable to work due to RA	0.18 units on a scale Standard Deviation 0.54	0.15 units on a scale Standard Deviation 0.50	0.05 units on a scale Standard Deviation 0.55
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: lost job/retired early	0.00 units on a scale Standard Deviation 0.47	0.01 units on a scale Standard Deviation 0.35	0.04 units on a scale Standard Deviation 0.46
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: work disabled due to RA	0.14 units on a scale Standard Deviation 0.49	0.13 units on a scale Standard Deviation 0.44	0.07 units on a scale Standard Deviation 0.42
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: retired	-0.01 units on a scale Standard Deviation 0.30	-0.03 units on a scale Standard Deviation 0.30	0.03 units on a scale Standard Deviation 0.36
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: sick leave due to RA	0.21 units on a scale Standard Deviation 0.46	0.23 units on a scale Standard Deviation 0.43	0.17 units on a scale Standard Deviation 0.44
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: performed part-time work	0.09 units on a scale Standard Deviation 0.34	0.09 units on a scale Standard Deviation 0.33	0.12 units on a scale Standard Deviation 0.45
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: performed paid work	0.18 units on a scale Standard Deviation 0.51	0.26 units on a scale Standard Deviation 0.52	0.14 units on a scale Standard Deviation 0.48
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: unable to do chores	0.37 units on a scale Standard Deviation 0.54	0.41 units on a scale Standard Deviation 0.54	0.24 units on a scale Standard Deviation 0.56
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: chores by housekeeper	0.04 units on a scale Standard Deviation 0.25	0.08 units on a scale Standard Deviation 0.32	0.01 units on a scale Standard Deviation 0.24
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Month 6: chores by family/friends	0.30 units on a scale Standard Deviation 0.52	0.34 units on a scale Standard Deviation 0.50	0.22 units on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Months 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

SECONDARY outcome

Timeframe: Months 3 and 6

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=215 Participants 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.	CP-690,550 10 mg BID n=250 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=115 Participants 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.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3: doctor visits	-1.83 events Standard Deviation 5.24	-1.12 events Standard Deviation 4.13	-1.52 events Standard Deviation 5.46
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3: RA-related doctor visit	-0.55 events Standard Deviation 1.30	-0.50 events Standard Deviation 1.14	-0.48 events Standard Deviation 0.99
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3: hospital ER visit	-4.33 events Standard Deviation 5.86	1.60 events Standard Deviation 3.78	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3: RA-related ER visit	-0.67 events Standard Deviation 1.15	-1.00 events Standard Deviation 1.58	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3: hospitalization	—	0.00 events Standard Deviation 0.00	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3: RA-related hospitalization	—	-0.50 events Standard Deviation 0.71	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3: non-study diagnostic test	-0.73 events Standard Deviation 2.24	-0.61 events Standard Deviation 1.50	0.38 events Standard Deviation 1.19
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3: RA-related diagnostic test	-0.73 events Standard Deviation 1.01	-0.67 events Standard Deviation 1.20	-0.50 events Standard Deviation 0.93
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3:non-medical practitioner visit	-62.33 events Standard Deviation 102.11	-2.33 events Standard Deviation 2.52	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 3:RA-related non-medical visit	-0.67 events Standard Deviation 0.58	-0.33 events Standard Deviation 0.58	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6: doctor visit	-2.44 events Standard Deviation 4.87	-1.98 events Standard Deviation 4.65	-2.72 events Standard Deviation 5.43
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6: RA-related doctor visit	-0.69 events Standard Deviation 1.27	-0.66 events Standard Deviation 1.23	-0.77 events Standard Deviation 1.10
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6: hospital ER visit	—	0.60 events Standard Deviation 1.34	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6: RA-related ER visit	—	-0.40 events Standard Deviation 1.14	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6: hospitalization	—	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6: RA-related hospitalization	—	-1.50 events Standard Deviation 0.71	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6: non-study diagnostic test	-0.60 events Standard Deviation 1.52	-0.40 events Standard Deviation 1.30	-0.67 events Standard Deviation 2.16
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6: RA related diagnostic test	-0.80 events Standard Deviation 1.64	-0.88 events Standard Deviation 1.09	-0.67 events Standard Deviation 0.82
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6:non-medical practitioner visit	-8.00 events Standard Deviation 2.83	-5.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Month 6:RA-related non-medical visit	0.00 events Standard Deviation 0.00	-1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.

SECONDARY outcome

Timeframe: Months 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=167 Participants 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.	CP-690,550 10 mg BID n=174 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=78 Participants 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.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: doctor visit	-2.57 events Standard Deviation 5.87	-2.32 events Standard Deviation 4.33	-3.17 events Standard Deviation 5.86
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related doctor visit	-0.72 events Standard Deviation 1.30	-0.68 events Standard Deviation 1.12	-0.72 events Standard Deviation 1.14
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: hospital ER visit	-3.50 events Standard Deviation 5.07	0.00 events Standard Deviation 0.00	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related ER visit	-1.25 events Standard Deviation 0.96	-1.00 events Standard Deviation 1.41	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: hospitalization	0.00 events Standard Deviation 0.00	—	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related hospitalization	-0.50 events Standard Deviation 0.71	—	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:non-study diagnostic tests	-0.09 events Standard Deviation 2.88	-0.71 events Standard Deviation 1.69	-1.00 events Standard Deviation 1.00
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related diagnostic tests	-0.82 events Standard Deviation 1.25	-0.88 events Standard Deviation 1.69	-0.60 events Standard Deviation 0.89
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:non-medical practitioner visit	-8.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	8.00 events Standard Deviation 11.31	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:RA-related non-medical visit	-2.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	0.00 events Standard Deviation 0.00	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: doctor visits	-2.58 events Standard Deviation 4.37	-1.98 events Standard Deviation 3.67	-2.20 events Standard Deviation 6.97
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: RA-related doctor visit	-0.69 events Standard Deviation 1.17	-0.51 events Standard Deviation 1.03	-0.69 events Standard Deviation 1.21
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: hospital ER visit	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	-1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: RA-related ER visit	1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	-1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	-0.50 events Standard Deviation 0.71
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: hospitalization	—	—	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:RA-related hospitalization	—	—	-1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: outpatient surgery	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:RA-related outpatient surgery	2.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:non-study diagnostic test	-1.55 events Standard Deviation 2.73	0.00 events Standard Deviation 2.24	-0.50 events Standard Deviation 2.12
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:RA-related diagnostic test	-0.33 events Standard Deviation 0.58	-0.64 events Standard Deviation 0.67	-0.50 events Standard Deviation 0.71
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:non-medical practitioner visit	-10.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	-15.67 events Standard Deviation 28.01	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:RA-related non-medical visit	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	0.33 events Standard Deviation 1.53	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: doctor visit	-2.78 events Standard Deviation 6.00	-1.65 events Standard Deviation 5.42	-2.41 events Standard Deviation 6.48
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: RA-related doctor visit	-0.71 events Standard Deviation 1.37	-0.63 events Standard Deviation 1.15	-0.63 events Standard Deviation 1.10
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: hospital ER visit	0.00 events Standard Deviation 0.00	-1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: RA-related ER visit	-0.67 events Standard Deviation 1.15	-2.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: outpatient surgery	4.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:RA-relate outpatient surgery	-1.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:non-study diagnostic test	-1.50 events Standard Deviation 4.20	-0.18 events Standard Deviation 1.08	-0.50 events Standard Deviation 0.71
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:RA related diagnostic test	-0.33 events Standard Deviation 0.58	-0.64 events Standard Deviation 0.67	-0.50 events Standard Deviation 0.71
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:non-medical practitioner visit	-168.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	-1.00 events Standard Deviation 1.41	—
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:RA-related non-medical visit	0.00 events Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	-0.33 events Standard Deviation 0.58	—

SECONDARY outcome

Timeframe: Months 3 and 6

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=154 Participants 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.	CP-690,550 10 mg BID n=164 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=74 Participants 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.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: hospital length of stay	—	-10.00 days Standard Deviation 7.07	—
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: days in nursing home	—	0.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: days aids/devices used	-45.92 days Standard Deviation 91.00	-12.36 days Standard Deviation 173.11	-65.50 days Standard Deviation 200.00
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: RA-related aids used	-0.31 days Standard Deviation 1.11	-0.43 days Standard Deviation 1.91	-0.25 days Standard Deviation 2.05
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: days of work per week	0.13 days Standard Deviation 0.69	0.06 days Standard Deviation 0.74	-0.01 days Standard Deviation 0.54
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3:days on sick leave due to RA	0.40 days Standard Deviation 32.44	7.58 days Standard Deviation 26.57	10.94 days Standard Deviation 33.96
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: days of part time work	1.92 days Standard Deviation 32.76	15.14 days Standard Deviation 34.60	-0.17 days Standard Deviation 26.90
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: paid work, bothered by RA	-15.31 days Standard Deviation 39.58	-15.16 days Standard Deviation 34.88	-9.30 days Standard Deviation 31.97
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: chores by housekeeper	-20.70 days Standard Deviation 35.90	-11.61 days Standard Deviation 31.25	-9.29 days Standard Deviation 36.09
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 3: chores by family	-19.14 days Standard Deviation 40.06	-17.71 days Standard Deviation 36.57	-12.18 days Standard Deviation 35.70
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: hospital length of stay	—	-22.00 days Standard Deviation 2.83	8.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: days in nursing home	—	0.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: days aids/devices used	-46.93 days Standard Deviation 127.42	58.00 days Standard Deviation 126.45	-93.20 days Standard Deviation 211.52
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: RA-related aids used	-0.64 days Standard Deviation 1.50	0.13 days Standard Deviation 0.99	-1.60 days Standard Deviation 2.70
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: days of work per week	0.07 days Standard Deviation 0.67	0.03 days Standard Deviation 0.73	0.00 days Standard Deviation 0.50
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6:days on sick leave due to RA	-18.27 days Standard Deviation 17.19	13.56 days Standard Deviation 27.92	13.82 days Standard Deviation 46.97
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: days of part time work	11.50 days Standard Deviation 14.34	-2.60 days Standard Deviation 18.57	0.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: paid work, bothered by RA	-15.90 days Standard Deviation 36.80	-16.43 days Standard Deviation 30.15	-7.81 days Standard Deviation 38.47
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: chores by housekeeper	-13.80 days Standard Deviation 19.66	-11.94 days Standard Deviation 33.28	-2.40 days Standard Deviation 7.70
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Month 6: chores by family	-14.94 days Standard Deviation 39.94	-20.54 days Standard Deviation 37.40	-20.94 days Standard Deviation 40.56

SECONDARY outcome

Timeframe: Months 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=131 Participants 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.	CP-690,550 10 mg BID n=130 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=57 Participants 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.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: hospital length of stay	-2.00 days Standard Deviation 2.83	—	—
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: days in nursing home	—	3.50 days Standard Deviation 4.95	—
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: days aids/devices used	-27.07 days Standard Deviation 159.25	-5.00 days Standard Deviation 81.85	-75.00 days Standard Deviation 63.64
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: RA-related aids used	-0.46 days Standard Deviation 1.71	0.00 days Standard Deviation 0.82	0.00 days Standard Deviation 0.00
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: days of work per week	0.11 days Standard Deviation 0.86	-0.01 days Standard Deviation 0.66	0.04 days Standard Deviation 0.42
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:days on sick leave due to RA	5.25 days Standard Deviation 28.21	-2.80 days Standard Deviation 16.41	-2.20 days Standard Deviation 2.49
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: days of part-time work	2.20 days Standard Deviation 6.83	-15.00 days Standard Deviation 17.00	—
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12:paid work, bothered by RA	-18.49 days Standard Deviation 28.09	-12.63 days Standard Deviation 34.77	-12.35 days Standard Deviation 37.16
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: chores by housekeeper	-8.43 days Standard Deviation 14.55	-1.92 days Standard Deviation 6.19	4.67 days Standard Deviation 5.03
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: chores by family	-13.11 days Standard Deviation 34.25	-20.05 days Standard Deviation 44.57	-15.24 days Standard Deviation 29.17
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: hospital length of stay	—	—	21.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: days aids/devices used	65.09 days Standard Deviation 81.85	96.00 days Standard Deviation 53.39	-77.33 days Standard Deviation 289.83
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: RA-related aids used	0.82 days Standard Deviation 0.87	1.00 days Standard Deviation 0.82	0.00 days Standard Deviation 1.73
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: days of work per week	0.13 days Standard Deviation 0.85	-0.04 days Standard Deviation 0.85	-0.06 days Standard Deviation 0.60
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:days on sick leave due to RA	-4.80 days Standard Deviation 13.18	-6.78 days Standard Deviation 8.94	-31.67 days Standard Deviation 47.93
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: days of part time work	-1.00 days Standard Deviation 4.85	-35.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18:paid work, bothered by RA	-15.19 days Standard Deviation 39.72	-20.12 days Standard Deviation 33.90	-15.07 days Standard Deviation 43.23
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: chores by housekeeper	-24.50 days Standard Deviation 32.54	-19.22 days Standard Deviation 28.80	-5.50 days Standard Deviation 7.78
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: chores by family	-9.15 days Standard Deviation 34.94	-14.17 days Standard Deviation 35.55	3.36 days Standard Deviation 30.47
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: days aids/devices used	79.90 days Standard Deviation 127.89	-38.50 days Standard Deviation 50.79	-45.00 days Standard Deviation 198.24
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: RA-related aids used	1.10 days Standard Deviation 1.20	-0.50 days Standard Deviation 1.00	-0.75 days Standard Deviation 2.36
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: days of work per week	0.06 days Standard Deviation 0.87	0.05 days Standard Deviation 0.78	0.05 days Standard Deviation 0.79
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24:days on sick leave due to RA	-3.86 days Standard Deviation 7.06	-3.00 days Standard Deviation 5.66	-5.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: days of part time work	1.67 days Standard Deviation 6.03	-45.00 days Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: paid work, bothered by RA	-12.54 days Standard Deviation 37.97	-23.63 days Standard Deviation 26.77	-22.47 days Standard Deviation 25.29
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: chores by housekeeper	-15.33 days Standard Deviation 24.10	-12.00 days Standard Deviation 29.28	0.00 days Standard Deviation 5.66
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: chores by family	-7.30 days Standard Deviation 31.83	-27.54 days Standard Deviation 37.94	-13.86 days Standard Deviation 37.70

SECONDARY outcome

Timeframe: Months 3 and 6

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=154 Participants 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.	CP-690,550 10 mg BID n=165 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=74 Participants 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.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 6: chores by family	-0.68 hours per day Standard Deviation 4.15	-0.51 hours per day Standard Deviation 3.02	-0.45 hours per day Standard Deviation 6.24
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 3: home healthcare services	—	-1.00 hours per day Standard Deviation 1.41	—
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 3:RA-related home HC services	—	0.00 hours per day Standard Deviation 0.00	—
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 3: work done	0.23 hours per day Standard Deviation 4.19	0.34 hours per day Standard Deviation 6.12	0.80 hours per day Standard Deviation 3.82
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 3: missed work due to RA	-1.00 hours per day Standard Deviation 8.94	1.29 hours per day Standard Deviation 5.06	3.00 hours per day Standard Deviation 9.36
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 3: chores by housekeeper	-0.80 hours per day Standard Deviation 1.62	-0.61 hours per day Standard Deviation 2.37	-1.14 hours per day Standard Deviation 1.86
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 3: chores by family	-1.98 hours per day Standard Deviation 4.92	-0.39 hours per day Standard Deviation 3.90	-1.63 hours per day Standard Deviation 5.14
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 6: work done	-0.34 hours per day Standard Deviation 4.32	0.03 hours per day Standard Deviation 4.79	0.23 hours per day Standard Deviation 1.48
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 6: missed work due to RA	-1.67 hours per day Standard Deviation 5.13	-0.40 hours per day Standard Deviation 1.14	-4.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Month 6: chores by housekeeper	-1.10 hours per day Standard Deviation 2.38	-0.25 hours per day Standard Deviation 3.19	-0.20 hours per day Standard Deviation 1.30

SECONDARY outcome

Timeframe: Months 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=131 Participants 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.	CP-690,550 10 mg BID n=131 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=57 Participants 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.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: work done	0.34 hours per day Standard Deviation 4.30	-0.21 hours per day Standard Deviation 4.37	0.75 hours per day Standard Deviation 4.43
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: missed work due to RA	-1.60 hours per day Standard Deviation 4.93	0.00 hours per day Standard Deviation 1.00	—
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: chores by housekeeper	0.29 hours per day Standard Deviation 2.63	-5.23 hours per day Standard Deviation 18.66	-0.50 hours per day Standard Deviation 0.71
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 12: chores by family	-0.67 hours per day Standard Deviation 4.67	-1.35 hours per day Standard Deviation 6.69	-0.24 hours per day Standard Deviation 3.10
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: work done	0.17 hours per day Standard Deviation 4.56	0.16 hours per day Standard Deviation 5.24	0.04 hours per day Standard Deviation 1.37
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: missed work due to RA	-5.80 hours per day Standard Deviation 11.97	1.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: chores by housekeeper	-2.00 hours per day Standard Deviation 2.16	-8.78 hours per day Standard Deviation 22.26	0.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 18: chores by family	0.03 hours per day Standard Deviation 3.43	-1.57 hours per day Standard Deviation 5.25	-0.17 hours per day Standard Deviation 1.19
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: work done	0.42 hours per day Standard Deviation 5.37	-0.04 hours per day Standard Deviation 2.51	0.17 hours per day Standard Deviation 1.32
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: missed work due to RA	-5.33 hours per day Standard Deviation 7.57	0.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.	—
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: chores by housekeeper	0.17 hours per day Standard Deviation 3.06	0.50 hours per day Standard Deviation 1.51	1.00 hours per day Standard Deviation NA Standard deviation could not be calculated as only 1 participant contributed data for this variable at this timepoint.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Month 24: chores by family	-0.97 hours per day Standard Deviation 3.40	-1.00 hours per day Standard Deviation 3.00	-0.47 hours per day Standard Deviation 1.36

SECONDARY outcome

Timeframe: Months 3, 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=242 Participants 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.	CP-690,550 10 mg BID n=258 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=113 Participants 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.
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 3	-1.40 units on a scale Standard Deviation 2.88	-1.45 units on a scale Standard Deviation 3.90	-0.81 units on a scale Standard Deviation 2.94
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 6	-2.11 units on a scale Standard Deviation 2.92	-2.44 units on a scale Standard Deviation 2.97	-1.22 units on a scale Standard Deviation 3.39
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 12	-2.15 units on a scale Standard Deviation 3.22	-2.68 units on a scale Standard Deviation 3.17	-1.51 units on a scale Standard Deviation 2.93
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 18	-2.28 units on a scale Standard Deviation 3.25	-2.62 units on a scale Standard Deviation 3.15	-2.22 units on a scale Standard Deviation 3.33
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Month 24	-2.24 units on a scale Standard Deviation 3.36	-2.38 units on a scale Standard Deviation 3.11	-1.88 units on a scale Standard Deviation 3.24

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, and 3

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=372 Participants 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.	CP-690,550 10 mg BID n=397 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=186 Participants 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.
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 BL: overall sleep problem	42.65 units on a scale Standard Deviation 19.48	42.82 units on a scale Standard Deviation 20.51	42.84 units on a scale Standard Deviation 18.07
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 BL: sleep problem summary	40.66 units on a scale Standard Deviation 19.84	41.43 units on a scale Standard Deviation 20.77	41.13 units on a scale Standard Deviation 18.20
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 BL: somnolence	35.77 units on a scale Standard Deviation 21.68	36.68 units on a scale Standard Deviation 22.28	38.21 units on a scale Standard Deviation 21.19
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 BL: snoring	34.30 units on a scale Standard Deviation 32.90	31.99 units on a scale Standard Deviation 32.37	32.58 units on a scale Standard Deviation 32.13
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 BL: sleep disturbance	45.61 units on a scale Standard Deviation 25.91	44.77 units on a scale Standard Deviation 26.54	44.30 units on a scale Standard Deviation 25.52
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 BL: awaken short of breath	20.43 units on a scale Standard Deviation 25.52	19.35 units on a scale Standard Deviation 24.42	18.71 units on a scale Standard Deviation 23.40
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 BL: adequacy	46.29 units on a scale Standard Deviation 26.63	44.41 units on a scale Standard Deviation 26.95	44.65 units on a scale Standard Deviation 26.22
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 1: overall sleep problem	33.74 units on a scale Standard Deviation 18.23	33.60 units on a scale Standard Deviation 20.19	38.15 units on a scale Standard Deviation 17.57
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 1: sleep problem summary	33.11 units on a scale Standard Deviation 18.84	33.21 units on a scale Standard Deviation 20.83	37.28 units on a scale Standard Deviation 18.17
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 1: somnolence	29.75 units on a scale Standard Deviation 19.71	29.15 units on a scale Standard Deviation 19.65	35.11 units on a scale Standard Deviation 19.21
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 1: snoring	30.30 units on a scale Standard Deviation 29.30	28.21 units on a scale Standard Deviation 30.26	30.76 units on a scale Standard Deviation 31.63
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 1: sleep disturbance	33.81 units on a scale Standard Deviation 22.52	33.58 units on a scale Standard Deviation 24.94	37.09 units on a scale Standard Deviation 23.70
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 1: awaken short of breath	16.66 units on a scale Standard Deviation 22.84	17.40 units on a scale Standard Deviation 23.90	17.07 units on a scale Standard Deviation 22.76
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 1: adequacy	53.64 units on a scale Standard Deviation 26.20	54.08 units on a scale Standard Deviation 27.32	47.23 units on a scale Standard Deviation 24.62
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 2: overall sleep problem	31.73 units on a scale Standard Deviation 18.37	32.76 units on a scale Standard Deviation 20.25	35.25 units on a scale Standard Deviation 17.24
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 2: sleep problem summary	31.26 units on a scale Standard Deviation 18.68	32.71 units on a scale Standard Deviation 20.63	34.66 units on a scale Standard Deviation 17.19
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 2: somnolence	27.96 units on a scale Standard Deviation 19.32	29.02 units on a scale Standard Deviation 21.10	31.65 units on a scale Standard Deviation 19.75
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 2: snoring	31.09 units on a scale Standard Deviation 28.38	28.92 units on a scale Standard Deviation 30.40	28.20 units on a scale Standard Deviation 28.56
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 2: sleep disturbance	30.93 units on a scale Standard Deviation 23.06	32.31 units on a scale Standard Deviation 24.56	34.56 units on a scale Standard Deviation 22.32
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 2: awaken short of breath	15.44 units on a scale Standard Deviation 21.04	17.16 units on a scale Standard Deviation 22.07	15.96 units on a scale Standard Deviation 20.21
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 2: adequacy	54.83 units on a scale Standard Deviation 26.71	55.08 units on a scale Standard Deviation 27.81	50.84 units on a scale Standard Deviation 25.73
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 3: overall sleep problem	30.07 units on a scale Standard Deviation 18.59	31.55 units on a scale Standard Deviation 19.86	33.93 units on a scale Standard Deviation 18.86
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 3: sleep problem summary	29.87 units on a scale Standard Deviation 19.22	31.76 units on a scale Standard Deviation 20.55	33.66 units on a scale Standard Deviation 19.82
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 3: somnolence	27.18 units on a scale Standard Deviation 18.34	29.16 units on a scale Standard Deviation 20.99	30.39 units on a scale Standard Deviation 19.13
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 3: snoring	30.06 units on a scale Standard Deviation 30.12	27.94 units on a scale Standard Deviation 30.11	28.60 units on a scale Standard Deviation 28.46
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 3: sleep disturbance	29.24 units on a scale Standard Deviation 22.54	29.83 units on a scale Standard Deviation 24.10	32.76 units on a scale Standard Deviation 23.87
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 3: awaken short of breath	16.76 units on a scale Standard Deviation 22.64	16.87 units on a scale Standard Deviation 22.25	16.74 units on a scale Standard Deviation 21.71
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Month 3: adequacy	58.55 units on a scale Standard Deviation 27.53	55.27 units on a scale Standard Deviation 27.60	51.74 units on a scale Standard Deviation 26.72

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=367 Participants 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.	CP-690,550 10 mg BID n=393 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS Month 1	55.31 percentage of participants	55.22 percentage of participants	51.09 percentage of participants
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS Month 2	57.06 percentage of participants	55.41 percentage of participants	48.88 percentage of participants
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS Month 3	58.71 percentage of participants	60.05 percentage of participants	51.74 percentage of participants
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS Month 6	61.76 percentage of participants	58.04 percentage of participants	58.23 percentage of participants
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS Month 12	58.10 percentage of participants	58.43 percentage of participants	50.00 percentage of participants
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS Month 18	63.03 percentage of participants	62.37 percentage of participants	52.59 percentage of participants
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS Month 24	61.74 percentage of participants	55.87 percentage of participants	55.66 percentage of participants

SECONDARY outcome

Timeframe: Months 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=340 Participants 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.	CP-690,550 10 mg BID n=366 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=158 Participants 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.
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 6: overall sleep problem	30.73 units on a scale Standard Deviation 18.51	30.05 units on a scale Standard Deviation 20.09	32.71 units on a scale Standard Deviation 19.54
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 6: sleep problem summary	30.59 units on a scale Standard Deviation 19.02	29.81 units on a scale Standard Deviation 20.75	32.17 units on a scale Standard Deviation 19.47
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 6: somnolence	26.82 units on a scale Standard Deviation 18.62	27.34 units on a scale Standard Deviation 20.69	29.79 units on a scale Standard Deviation 19.76
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 6: snoring	30.12 units on a scale Standard Deviation 29.49	31.01 units on a scale Standard Deviation 30.68	27.39 units on a scale Standard Deviation 29.11
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 6: sleep disturbance	29.26 units on a scale Standard Deviation 22.20	28.61 units on a scale Standard Deviation 24.64	31.76 units on a scale Standard Deviation 25.72
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 6: awaken short of breath	17.00 units on a scale Standard Deviation 22.24	14.70 units on a scale Standard Deviation 21.28	14.68 units on a scale Standard Deviation 20.98
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 6: adequacy	56.09 units on a scale Standard Deviation 26.92	56.45 units on a scale Standard Deviation 27.84	53.61 units on a scale Standard Deviation 26.74
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 12: overall sleep problem	30.01 units on a scale Standard Deviation 17.75	29.30 units on a scale Standard Deviation 18.50	33.49 units on a scale Standard Deviation 18.56
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 12: sleep problem summary	29.89 units on a scale Standard Deviation 18.87	29.10 units on a scale Standard Deviation 18.99	33.70 units on a scale Standard Deviation 19.36
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 12: somnolence	26.62 units on a scale Standard Deviation 18.29	27.17 units on a scale Standard Deviation 20.09	31.11 units on a scale Standard Deviation 18.47
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 12: snoring	32.13 units on a scale Standard Deviation 28.80	31.76 units on a scale Standard Deviation 31.54	30.67 units on a scale Standard Deviation 27.84
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 12: sleep disturbance	28.73 units on a scale Standard Deviation 20.85	27.75 units on a scale Standard Deviation 22.73	32.44 units on a scale Standard Deviation 23.52
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 12: awaken short of breath	15.81 units on a scale Standard Deviation 22.01	14.73 units on a scale Standard Deviation 21.89	16.59 units on a scale Standard Deviation 21.10
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 12: adequacy	56.98 units on a scale Standard Deviation 27.00	58.18 units on a scale Standard Deviation 27.13	54.15 units on a scale Standard Deviation 26.80
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 18: overall sleep problem	29.99 units on a scale Standard Deviation 17.44	28.54 units on a scale Standard Deviation 17.92	31.93 units on a scale Standard Deviation 19.62
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 18: sleep problem summary	29.94 units on a scale Standard Deviation 17.82	28.15 units on a scale Standard Deviation 18.38	32.24 units on a scale Standard Deviation 20.72
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 18: somnolence	25.77 units on a scale Standard Deviation 17.62	26.73 units on a scale Standard Deviation 18.78	28.68 units on a scale Standard Deviation 19.90
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 18:snoring	33.07 units on a scale Standard Deviation 28.88	31.13 units on a scale Standard Deviation 29.89	29.74 units on a scale Standard Deviation 29.90
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 18: sleep disturbance	29.04 units on a scale Standard Deviation 21.28	27.30 units on a scale Standard Deviation 21.32	29.31 units on a scale Standard Deviation 22.59
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 18: awaken short of breath	15.42 units on a scale Standard Deviation 20.11	13.38 units on a scale Standard Deviation 19.82	16.55 units on a scale Standard Deviation 21.47
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 18: adequacy	57.11 units on a scale Standard Deviation 26.35	59.01 units on a scale Standard Deviation 27.11	53.62 units on a scale Standard Deviation 29.50
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 24: overall sleep problem	29.78 units on a scale Standard Deviation 17.64	29.55 units on a scale Standard Deviation 19.26	32.25 units on a scale Standard Deviation 19.17
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 24: sleep problem summary	30.01 units on a scale Standard Deviation 18.21	29.57 units on a scale Standard Deviation 19.80	31.79 units on a scale Standard Deviation 19.69
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 24: somnolence	25.71 units on a scale Standard Deviation 18.41	26.98 units on a scale Standard Deviation 20.53	28.36 units on a scale Standard Deviation 18.36
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 24: snoring	32.44 units on a scale Standard Deviation 29.18	30.22 units on a scale Standard Deviation 30.53	30.00 units on a scale Standard Deviation 28.32
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 24: sleep disturbance	29.03 units on a scale Standard Deviation 21.00	27.74 units on a scale Standard Deviation 23.40	31.43 units on a scale Standard Deviation 23.59
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 24: awaken short of breath	15.45 units on a scale Standard Deviation 21.23	15.90 units on a scale Standard Deviation 20.86	16.60 units on a scale Standard Deviation 19.99
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Month 24: adequacy	57.46 units on a scale Standard Deviation 28.15	57.52 units on a scale Standard Deviation 27.70	56.42 units on a scale Standard Deviation 26.66

SECONDARY outcome

Timeframe: Months 1, 2, and 3

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=364 Participants 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.	CP-690,550 10 mg BID n=392 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=184 Participants 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.
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 1: overall sleep problem	-8.95 units on a scale Standard Error 0.86	-9.14 units on a scale Standard Error 0.83	-4.72 units on a scale Standard Error 1.19
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 1: sleep problem summary	-7.85 units on a scale Standard Error 0.90	-8.12 units on a scale Standard Error 0.86	-3.98 units on a scale Standard Error 1.24
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 1: somnolence	-6.35 units on a scale Standard Error 0.95	-7.31 units on a scale Standard Error 0.91	-2.15 units on a scale Standard Error 1.31
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 1: snoring	-3.12 units on a scale Standard Error 1.19	-3.72 units on a scale Standard Error 1.14	-1.66 units on a scale Standard Error 1.65
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 1: quantity	0.41 units on a scale Standard Error 0.06	0.38 units on a scale Standard Error 0.06	0.26 units on a scale Standard Error 0.09
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 1: sleep disturbance	-11.28 units on a scale Standard Error 1.07	-11.06 units on a scale Standard Error 1.03	-7.36 units on a scale Standard Error 1.48
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 1: awaken short of breath	-2.81 units on a scale Standard Error 1.04	-1.92 units on a scale Standard Error 1.00	-2.00 units on a scale Standard Error 1.44
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 1: adequacy	8.56 units on a scale Standard Error 1.33	9.73 units on a scale Standard Error 1.28	2.83 units on a scale Standard Error 1.84
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 2: overall sleep problem	-11.08 units on a scale Standard Error 0.87	-10.15 units on a scale Standard Error 0.83	-7.62 units on a scale Standard Error 1.20
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 2: sleep problem summary	-9.81 units on a scale Standard Error 0.90	-8.75 units on a scale Standard Error 0.86	-6.54 units on a scale Standard Error 1.25
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 2: somnolence	-8.11 units on a scale Standard Error 0.95	-7.56 units on a scale Standard Error 0.91	-5.45 units on a scale Standard Error 1.33
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 2: snoring	-2.31 units on a scale Standard Error 1.20	-3.16 units on a scale Standard Error 1.14	-4.54 units on a scale Standard Error 1.67
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 2: quantity	0.42 units on a scale Standard Error 0.06	0.43 units on a scale Standard Error 0.06	0.31 units on a scale Standard Error 0.09
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 2: sleep disturbance	-14.27 units on a scale Standard Error 1.08	-12.53 units on a scale Standard Error 1.03	-9.97 units on a scale Standard Error 1.50
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 2: awaken short of breath	-4.12 units on a scale Standard Error 1.05	-2.15 units on a scale Standard Error 1.00	-3.32 units on a scale Standard Error 1.46
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 2: adequacy	9.90 units on a scale Standard Error 1.34	10.84 units on a scale Standard Error 1.28	6.24 units on a scale Standard Error 1.87
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 3: overall sleep problem	-12.46 units on a scale Standard Error 0.87	-11.16 units on a scale Standard Error 0.83	-8.99 units on a scale Standard Error 1.22
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 3: sleep problem summary	-10.98 units on a scale Standard Error 0.90	-9.58 units on a scale Standard Error 0.86	-7.65 units on a scale Standard Error 1.26
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 3: somnolence	-8.71 units on a scale Standard Error 0.96	-7.35 units on a scale Standard Error 0.91	-6.39 units on a scale Standard Error 1.34
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 3: snoring	-3.36 units on a scale Standard Error 1.21	-4.25 units on a scale Standard Error 1.15	-3.36 units on a scale Standard Error 1.69
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 3: quantity	0.45 units on a scale Standard Error 0.06	0.46 units on a scale Standard Error 0.06	0.40 units on a scale Standard Error 0.09
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 3: sleep disturbance	-15.67 units on a scale Standard Error 1.08	-14.67 units on a scale Standard Error 1.03	-11.90 units on a scale Standard Error 1.52
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 3: awaken short of breath	-2.60 units on a scale Standard Error 1.06	-2.48 units on a scale Standard Error 1.01	-2.67 units on a scale Standard Error 1.48
Change From Baseline in MOS-SS at Months 1, 2, and 3 Month 3: adequacy	13.46 units on a scale Standard Error 1.35	11.00 units on a scale Standard Error 1.29	7.14 units on a scale Standard Error 1.89

SECONDARY outcome

Timeframe: Months 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=339 Participants 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.	CP-690,550 10 mg BID n=366 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=158 Participants 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.
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 24: quantity	0.41 units on a scale Standard Deviation 0.07	0.31 units on a scale Standard Deviation 0.07	0.42 units on a scale Standard Deviation 0.11
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 6: overall sleep problem	-11.62 units on a scale Standard Deviation 0.88	-12.24 units on a scale Standard Deviation 0.84	-9.77 units on a scale Standard Deviation 1.24
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 6: sleep problem summary	-10.13 units on a scale Standard Deviation 0.91	-11.12 units on a scale Standard Deviation 0.87	-8.64 units on a scale Standard Deviation 1.29
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 6: somnolence	-8.86 units on a scale Standard Deviation 0.97	-8.83 units on a scale Standard Deviation 0.93	-6.60 units on a scale Standard Deviation 1.37
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 6: snoring	-3.21 units on a scale Standard Deviation 1.22	-1.11 units on a scale Standard Deviation 1.17	-4.00 units on a scale Standard Deviation 1.74
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 6: quantity	0.47 units on a scale Standard Deviation 0.07	0.44 units on a scale Standard Deviation 0.06	0.44 units on a scale Standard Deviation 0.09
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 6: sleep disturbance	-15.44 units on a scale Standard Deviation 1.10	-15.60 units on a scale Standard Deviation 1.05	-12.69 units on a scale Standard Deviation 1.55
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 6: awaken short of breath	-2.54 units on a scale Standard Deviation 1.07	-4.33 units on a scale Standard Deviation 1.02	-4.23 units on a scale Standard Deviation 1.53
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 6: adequacy	10.76 units on a scale Standard Deviation 1.36	11.57 units on a scale Standard Deviation 1.30	8.41 units on a scale Standard Deviation 1.94
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 12: overall sleep problem	-12.21 units on a scale Standard Deviation 0.90	-11.94 units on a scale Standard Deviation 0.86	-9.10 units on a scale Standard Deviation 1.30
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 12: sleep problem summary	-10.61 units on a scale Standard Deviation 0.93	-10.76 units on a scale Standard Deviation 0.90	-7.41 units on a scale Standard Deviation 1.35
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 24: adequacy	11.02 units on a scale Standard Deviation 1.47	11.87 units on a scale Standard Deviation 1.43	11.35 units on a scale Standard Deviation 2.22
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 12: adequacy	11.41 units on a scale Standard Deviation 1.40	12.15 units on a scale Standard Deviation 1.35	9.30 units on a scale Standard Deviation 2.05
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 18: overall sleep problem	-11.55 units on a scale Standard Deviation 0.92	-12.82 units on a scale Standard Deviation 0.89	-11.27 units on a scale Standard Deviation 1.36
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 18: sleep problem summary	-10.02 units on a scale Standard Deviation 0.96	-11.88 units on a scale Standard Deviation 0.93	-9.41 units on a scale Standard Deviation 1.41
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 18: somnolence	-9.19 units on a scale Standard Deviation 1.02	-8.70 units on a scale Standard Deviation 0.99	-7.88 units on a scale Standard Deviation 1.51
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 18:snoring	-0.45 units on a scale Standard Deviation 1.29	-0.59 units on a scale Standard Deviation 1.25	-3.61 units on a scale Standard Deviation 1.92
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 18: quantity	0.47 units on a scale Standard Deviation 0.07	0.38 units on a scale Standard Deviation 0.07	0.44 units on a scale Standard Deviation 0.10
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 18: sleep disturbance	-14.89 units on a scale Standard Deviation 1.15	-15.77 units on a scale Standard Deviation 1.12	-15.97 units on a scale Standard Deviation 1.71
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 18: awaken short of breath	-3.69 units on a scale Standard Deviation 1.14	-5.50 units on a scale Standard Deviation 1.11	-1.55 units on a scale Standard Deviation 1.71
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 18: adequacy	10.91 units on a scale Standard Deviation 1.44	13.26 units on a scale Standard Deviation 1.40	9.71 units on a scale Standard Deviation 2.15
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 24: overall sleep problem	-11.64 units on a scale Standard Deviation 0.94	-11.93 units on a scale Standard Deviation 0.90	-10.84 units on a scale Standard Deviation 1.39
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 24: sleep problem summary	-9.83 units on a scale Standard Deviation 0.98	-10.59 units on a scale Standard Deviation 0.94	-9.64 units on a scale Standard Deviation 1.45
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 24: somnolence	-9.29 units on a scale Standard Deviation 1.04	-8.63 units on a scale Standard Deviation 1.00	-8.24 units on a scale Standard Deviation 1.55
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 24: snoring	-1.00 units on a scale Standard Deviation 1.32	-1.22 units on a scale Standard Deviation 1.27	-3.49 units on a scale Standard Deviation 1.97
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 24: sleep disturbance	-14.67 units on a scale Standard Deviation 1.18	-15.43 units on a scale Standard Deviation 1.13	-14.20 units on a scale Standard Deviation 1.76
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 24: awaken short of breath	-3.77 units on a scale Standard Deviation 1.17	-3.16 units on a scale Standard Deviation 1.13	-1.69 units on a scale Standard Deviation 1.77
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 12: somnolence	-8.85 units on a scale Standard Deviation 0.99	-8.24 units on a scale Standard Deviation 0.95	-5.46 units on a scale Standard Deviation 1.44
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 12: snoring	-1.44 units on a scale Standard Deviation 1.25	0.20 units on a scale Standard Deviation 1.20	-1.49 units on a scale Standard Deviation 1.82
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 12: quantity	0.49 units on a scale Standard Deviation 0.07	0.37 units on a scale Standard Deviation 0.06	0.20 units on a scale Standard Deviation 0.10
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 12: sleep disturbance	-15.94 units on a scale Standard Deviation 1.12	-15.24 units on a scale Standard Deviation 1.08	-12.00 units on a scale Standard Deviation 1.63
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Month 12: awaken short of breath	-3.65 units on a scale Standard Deviation 1.10	-4.04 units on a scale Standard Deviation 1.06	-2.12 units on a scale Standard Deviation 1.62

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=373 Participants 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.	CP-690,550 10 mg BID n=396 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=185 Participants 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.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Baseline	28.47 units on a scale Standard Deviation 10.90	29.06 units on a scale Standard Deviation 10.72	28.55 units on a scale Standard Deviation 10.54
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Month 1	34.39 units on a scale Standard Deviation 10.06	36.03 units on a scale Standard Deviation 10.25	31.70 units on a scale Standard Deviation 10.20
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Month 2	36.08 units on a scale Standard Deviation 10.16	36.76 units on a scale Standard Deviation 10.20	32.83 units on a scale Standard Deviation 10.20
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Month 3	36.93 units on a scale Standard Deviation 10.09	37.63 units on a scale Standard Deviation 10.30	34.09 units on a scale Standard Deviation 9.56
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Month 6	37.55 units on a scale Standard Deviation 9.96	38.38 units on a scale Standard Deviation 9.93	35.38 units on a scale Standard Deviation 10.15
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Month 12	37.85 units on a scale Standard Deviation 10.00	38.95 units on a scale Standard Deviation 9.73	35.99 units on a scale Standard Deviation 9.40
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Month 18	38.45 units on a scale Standard Deviation 9.20	39.22 units on a scale Standard Deviation 9.39	35.97 units on a scale Standard Deviation 10.12
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Month 24	38.52 units on a scale Standard Deviation 9.37	39.38 units on a scale Standard Deviation 9.91	35.16 units on a scale Standard Deviation 10.65

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 12, 18, and 24

Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=365 Participants 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.	CP-690,550 10 mg BID n=391 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=183 Participants 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.
Change From Baseline in FACIT-Fatigue Scale Month 1	5.79 units on a scale Standard Deviation 0.47	7.14 units on a scale Standard Deviation 0.45	3.15 units on a scale Standard Deviation 0.66
Change From Baseline in FACIT-Fatigue Scale Month 2	7.44 units on a scale Standard Deviation 0.48	7.86 units on a scale Standard Deviation 0.45	4.22 units on a scale Standard Deviation 0.66
Change From Baseline in FACIT-Fatigue Scale Month 3	8.12 units on a scale Standard Deviation 0.48	8.70 units on a scale Standard Deviation 0.46	5.25 units on a scale Standard Deviation 0.67
Change From Baseline in FACIT-Fatigue Scale Month 6	8.71 units on a scale Standard Deviation 0.48	9.12 units on a scale Standard Deviation 0.46	6.33 units on a scale Standard Deviation 0.68
Change From Baseline in FACIT-Fatigue Scale Month 12	8.75 units on a scale Standard Deviation 0.49	9.18 units on a scale Standard Deviation 0.47	6.89 units on a scale Standard Deviation 0.71
Change From Baseline in FACIT-Fatigue Scale Month 18	8.98 units on a scale Standard Deviation 0.50	9.41 units on a scale Standard Deviation 0.49	7.14 units on a scale Standard Deviation 0.74
Change From Baseline in FACIT-Fatigue Scale Month 24	8.97 units on a scale Standard Deviation 0.51	9.57 units on a scale Standard Deviation 0.49	6.24 units on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: Heart rate was measured at every study visit to determine the overall health of the participants. Any abnormalities were recorded as adverse events. Change from baseline will be analyzed as part of the wider clinical program.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=362 Participants 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.	CP-690,550 10 mg BID n=390 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=182 Participants 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.
Change From Baseline in Heart Rate Month 1	-1.64 beats per minute Standard Deviation 8.15	-1.83 beats per minute Standard Deviation 8.34	-0.73 beats per minute Standard Deviation 7.96
Change From Baseline in Heart Rate Month 2	-1.37 beats per minute Standard Deviation 8.48	-1.02 beats per minute Standard Deviation 9.33	-2.19 beats per minute Standard Deviation 7.72
Change From Baseline in Heart Rate Month 3	-1.91 beats per minute Standard Deviation 9.27	-1.76 beats per minute Standard Deviation 9.40	-2.37 beats per minute Standard Deviation 8.48
Change From Baseline in Heart Rate Month 6	-1.62 beats per minute Standard Deviation 8.64	-1.70 beats per minute Standard Deviation 9.13	-2.24 beats per minute Standard Deviation 8.65
Change From Baseline in Heart Rate Month 9	-1.31 beats per minute Standard Deviation 9.07	-1.66 beats per minute Standard Deviation 9.23	-3.50 beats per minute Standard Deviation 9.36
Change From Baseline in Heart Rate Month 12	-2.36 beats per minute Standard Deviation 9.69	-2.88 beats per minute Standard Deviation 9.12	-4.08 beats per minute Standard Deviation 10.42
Change From Baseline in Heart Rate Month 15	-1.60 beats per minute Standard Deviation 9.22	-2.12 beats per minute Standard Deviation 10.24	-3.78 beats per minute Standard Deviation 9.66
Change From Baseline in Heart Rate Month 18	-2.45 beats per minute Standard Deviation 9.38	-2.03 beats per minute Standard Deviation 8.78	-2.23 beats per minute Standard Deviation 8.47
Change From Baseline in Heart Rate Month 21	-1.77 beats per minute Standard Deviation 9.97	-2.25 beats per minute Standard Deviation 8.71	-3.34 beats per minute Standard Deviation 9.24
Change From Baseline in Heart Rate Month 24	-3.08 beats per minute Standard Deviation 10.16	-3.31 beats per minute Standard Deviation 9.69	-4.26 beats per minute Standard Deviation 10.17

SECONDARY outcome

Timeframe: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Population: Temperature was measured at every study visit to determine the overall health of the participants. Any abnormalities were recorded as adverse events. Change from baseline in temperature will be analyzed as part of the wider clinical program.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg BID n=362 Participants 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.	CP-690,550 10 mg BID n=390 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=181 Participants 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.
Change From Baseline in Temperature Month 1	-0.07 degrees centigrade Standard Deviation 0.30	-0.05 degrees centigrade Standard Deviation 0.31	-0.05 degrees centigrade Standard Deviation 0.32
Change From Baseline in Temperature Month 2	-0.07 degrees centigrade Standard Deviation 0.32	-0.03 degrees centigrade Standard Deviation 0.37	-0.04 degrees centigrade Standard Deviation 0.35
Change From Baseline in Temperature Month 3	-0.08 degrees centigrade Standard Deviation 0.34	-0.04 degrees centigrade Standard Deviation 0.34	-0.05 degrees centigrade Standard Deviation 0.36
Change From Baseline in Temperature Month 6	-0.07 degrees centigrade Standard Deviation 0.35	-0.04 degrees centigrade Standard Deviation 0.36	-0.09 degrees centigrade Standard Deviation 0.38
Change From Baseline in Temperature Month 9	-0.07 degrees centigrade Standard Deviation 0.37	-0.06 degrees centigrade Standard Deviation 0.39	-0.08 degrees centigrade Standard Deviation 0.36
Change From Baseline in Temperature Month 12	-0.10 degrees centigrade Standard Deviation 0.34	-0.03 degrees centigrade Standard Deviation 0.39	-0.12 degrees centigrade Standard Deviation 0.37
Change From Baseline in Temperature Month 15	-0.08 degrees centigrade Standard Deviation 0.35	-0.05 degrees centigrade Standard Deviation 0.42	-0.10 degrees centigrade Standard Deviation 0.35
Change From Baseline in Temperature Month 18	-0.07 degrees centigrade Standard Deviation 0.41	-0.03 degrees centigrade Standard Deviation 0.42	-0.11 degrees centigrade Standard Deviation 0.38
Change From Baseline in Temperature Month 21	-0.09 degrees centigrade Standard Deviation 0.36	-0.07 degrees centigrade Standard Deviation 0.40	-0.13 degrees centigrade Standard Deviation 0.40
Change From Baseline in Temperature Month 24	-0.10 degrees centigrade Standard Deviation 0.37	-0.07 degrees centigrade Standard Deviation 0.40	-0.12 degrees centigrade Standard Deviation 0.37

Adverse Events

CP-690,550 5 mg BID

Serious events: 40 serious events

Other events: 252 other events

Deaths: 0 deaths

CP-690,550 10 mg BID

Serious events: 43 serious events

Other events: 279 other events

Deaths: 0 deaths

MTX 10, 15, or 20 mg, Weekly

Serious events: 22 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	CP-690,550 5 mg BID n=314 Participants 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.	CP-690,550 10 mg BID n=328 Participants 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.	MTX 10, 15, or 20 mg, Weekly n=135 Participants 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.
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month12:admitted for overnight stay	0.19 units on a scale Standard Deviation 0.54	0.25 units on a scale Standard Deviation 0.46	0.20 units on a scale Standard Deviation 0.45
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: hospitalized	1.98 units on a scale Standard Deviation 0.15	1.99 units on a scale Standard Deviation 0.11	1.99 units on a scale Standard Deviation 0.12
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: seen any doctor	1.45 units on a scale Standard Deviation 0.50	1.44 units on a scale Standard Deviation 0.50	1.41 units on a scale Standard Deviation 0.49
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: treated in ER	1.95 units on a scale Standard Deviation 0.21	1.98 units on a scale Standard Deviation 0.15	1.96 units on a scale Standard Deviation 0.19
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12:any outpatient surgery	1.97 units on a scale Standard Deviation 0.17	1.98 units on a scale Standard Deviation 0.15	1.98 units on a scale Standard Deviation 0.15
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12:non-study diagnostic tests	1.90 units on a scale Standard Deviation 0.30	1.88 units on a scale Standard Deviation 0.33	1.92 units on a scale Standard Deviation 0.27
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: in a nursing home	2.00 units on a scale Standard Deviation 0.00	1.99 units on a scale Standard Deviation 0.08	1.99 units on a scale Standard Deviation 0.09
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: home healthcare services	1.99 units on a scale Standard Deviation 0.08	1.99 units on a scale Standard Deviation 0.08	2.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: used aids/devices	1.94 units on a scale Standard Deviation 0.24	1.97 units on a scale Standard Deviation 0.16	1.97 units on a scale Standard Deviation 0.17
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: non-medical practitioner	1.99 units on a scale Standard Deviation 0.08	1.99 units on a scale Standard Deviation 0.11	2.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: currently employed	1.51 units on a scale Standard Deviation 0.50	1.53 units on a scale Standard Deviation 0.50	1.53 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: feel well enough to work	1.61 units on a scale Standard Deviation 0.49	1.56 units on a scale Standard Deviation 0.50	1.61 units on a scale Standard Deviation 0.49
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: unable to work due to RA	1.64 units on a scale Standard Deviation 0.48	1.73 units on a scale Standard Deviation 0.44	1.61 units on a scale Standard Deviation 0.49
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: Lost job/retired early	1.75 units on a scale Standard Deviation 0.44	1.81 units on a scale Standard Deviation 0.39	1.80 units on a scale Standard Deviation 0.40
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: work disabled due to RA	1.66 units on a scale Standard Deviation 0.48	1.73 units on a scale Standard Deviation 0.44	1.73 units on a scale Standard Deviation 0.45
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: retired	1.51 units on a scale Standard Deviation 0.50	1.52 units on a scale Standard Deviation 0.50	1.42 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: sick leave due to RA	1.94 units on a scale Standard Deviation 0.24	1.98 units on a scale Standard Deviation 0.14	1.93 units on a scale Standard Deviation 0.26
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: performed part time work	1.97 units on a scale Standard Deviation 0.18	1.97 units on a scale Standard Deviation 0.16	1.97 units on a scale Standard Deviation 0.16
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: performed paid work	1.80 units on a scale Standard Deviation 0.40	1.84 units on a scale Standard Deviation 0.36	1.72 units on a scale Standard Deviation 0.45
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: unable to do chores	1.79 units on a scale Standard Deviation 0.41	1.83 units on a scale Standard Deviation 0.37	1.79 units on a scale Standard Deviation 0.41
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: chores by housekeeper	1.96 units on a scale Standard Deviation 0.18	1.95 units on a scale Standard Deviation 0.21	1.96 units on a scale Standard Deviation 0.19
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 12: chores by family/friends	1.83 units on a scale Standard Deviation 0.38	1.86 units on a scale Standard Deviation 0.35	1.79 units on a scale Standard Deviation 0.41
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: seen any doctor	1.43 units on a scale Standard Deviation 0.50	1.49 units on a scale Standard Deviation 0.50	1.41 units on a scale Standard Deviation 0.49
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: treated in ER	1.96 units on a scale Standard Deviation 0.18	1.97 units on a scale Standard Deviation 0.17	1.96 units on a scale Standard Deviation 0.20
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month18:admitted for overnight stay	0.60 units on a scale Standard Deviation 0.97	0.33 units on a scale Standard Deviation 0.71	0.40 units on a scale Standard Deviation 0.89
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18:hospitalization	1.99 units on a scale Standard Deviation 0.10	1.98 units on a scale Standard Deviation 0.14	1.97 units on a scale Standard Deviation 0.16
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: outpatient surgery	1.98 units on a scale Standard Deviation 0.14	1.98 units on a scale Standard Deviation 0.15	1.97 units on a scale Standard Deviation 0.16
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18:non-study diagnostic tests	1.91 units on a scale Standard Deviation 0.29	1.91 units on a scale Standard Deviation 0.29	1.90 units on a scale Standard Deviation 0.31
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: in nursing home	2.00 units on a scale Standard Deviation 0.06	2.00 units on a scale Standard Deviation 0.00	2.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: home healthcare services	2.00 units on a scale Standard Deviation 0.06	2.00 units on a scale Standard Deviation 0.00	2.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: required aids/devices	1.96 units on a scale Standard Deviation 0.20	1.97 units on a scale Standard Deviation 0.16	1.97 units on a scale Standard Deviation 0.18
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: non-medical practitioner	1.99 units on a scale Standard Deviation 0.08	1.99 units on a scale Standard Deviation 0.12	1.99 units on a scale Standard Deviation 0.09
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: currently employed	1.50 units on a scale Standard Deviation 0.50	1.51 units on a scale Standard Deviation 0.50	1.55 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: feel well enough to work	1.53 units on a scale Standard Deviation 0.50	1.57 units on a scale Standard Deviation 0.50	1.67 units on a scale Standard Deviation 0.48
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: unable to work due to RA	1.73 units on a scale Standard Deviation 0.45	1.72 units on a scale Standard Deviation 0.45	1.59 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: lost job/retired early	1.80 units on a scale Standard Deviation 0.40	1.83 units on a scale Standard Deviation 0.38	1.80 units on a scale Standard Deviation 0.40
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: work disabled due to RA	1.76 units on a scale Standard Deviation 0.43	1.78 units on a scale Standard Deviation 0.42	1.66 units on a scale Standard Deviation 0.48
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: retired	1.49 units on a scale Standard Deviation 0.50	1.53 units on a scale Standard Deviation 0.50	1.48 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: sick leave due to RA	1.94 units on a scale Standard Deviation 0.23	1.96 units on a scale Standard Deviation 0.20	1.95 units on a scale Standard Deviation 0.22
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: performed part-time work	1.98 units on a scale Standard Deviation 0.15	1.98 units on a scale Standard Deviation 0.14	1.98 units on a scale Standard Deviation 0.14
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: unable to do chores	1.84 units on a scale Standard Deviation 0.36	1.84 units on a scale Standard Deviation 0.36	1.78 units on a scale Standard Deviation 0.42
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: chores by housekeeper	1.98 units on a scale Standard Deviation 0.14	1.96 units on a scale Standard Deviation 0.20	1.95 units on a scale Standard Deviation 0.22
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: performed paid work	1.78 units on a scale Standard Deviation 0.41	1.83 units on a scale Standard Deviation 0.38	1.79 units on a scale Standard Deviation 0.41
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 18: chores by family/friends	1.86 units on a scale Standard Deviation 0.35	1.89 units on a scale Standard Deviation 0.32	1.84 units on a scale Standard Deviation 0.37
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: seen any doctor	1.46 units on a scale Standard Deviation 0.50	1.50 units on a scale Standard Deviation 0.50	1.47 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: treated in ER	1.96 units on a scale Standard Deviation 0.19	1.96 units on a scale Standard Deviation 0.20	1.97 units on a scale Standard Deviation 0.17
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month24:admitted for overnight stay	0.20 units on a scale Standard Deviation 0.63	0.67 units on a scale Standard Deviation 0.98	0.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: Hospitalization	1.99 units on a scale Standard Deviation 0.11	1.99 units on a scale Standard Deviation 0.12	1.98 units on a scale Standard Deviation 0.14
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: outpatient surgery	1.98 units on a scale Standard Deviation 0.12	1.98 units on a scale Standard Deviation 0.13	1.99 units on a scale Standard Deviation 0.10
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24:non-study diagnostic test	1.92 units on a scale Standard Deviation 0.27	1.89 units on a scale Standard Deviation 0.32	1.86 units on a scale Standard Deviation 0.35
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: in nursing home	2.00 units on a scale Standard Deviation 0.06	1.99 units on a scale Standard Deviation 0.08	1.98 units on a scale Standard Deviation 0.14
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: home healthcare services	2.00 units on a scale Standard Deviation 0.00	1.99 units on a scale Standard Deviation 0.10	1.99 units on a scale Standard Deviation 0.10
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: required aids/devices	1.95 units on a scale Standard Deviation 0.22	1.96 units on a scale Standard Deviation 0.20	1.96 units on a scale Standard Deviation 0.19
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: non-medical practitioner	1.99 units on a scale Standard Deviation 0.11	1.98 units on a scale Standard Deviation 0.13	2.00 units on a scale Standard Deviation 0.00
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: currently employed	1.49 units on a scale Standard Deviation 0.50	1.54 units on a scale Standard Deviation 0.50	1.55 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: feel well enough to work	1.55 units on a scale Standard Deviation 0.50	1.57 units on a scale Standard Deviation 0.50	1.65 units on a scale Standard Deviation 0.48
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: unable to work due to RA	1.70 units on a scale Standard Deviation 0.46	1.75 units on a scale Standard Deviation 0.43	1.52 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: lost job/retired early	1.76 units on a scale Standard Deviation 0.43	1.83 units on a scale Standard Deviation 0.38	1.81 units on a scale Standard Deviation 0.39
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: work disabled due to RA	1.75 units on a scale Standard Deviation 0.43	1.77 units on a scale Standard Deviation 0.42	1.70 units on a scale Standard Deviation 0.46
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: retired	1.47 units on a scale Standard Deviation 0.50	1.49 units on a scale Standard Deviation 0.50	1.52 units on a scale Standard Deviation 0.50
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: sick leave due to RA	1.96 units on a scale Standard Deviation 0.20	1.98 units on a scale Standard Deviation 0.13	1.90 units on a scale Standard Deviation 0.31
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: performed part-time work	1.98 units on a scale Standard Deviation 0.15	1.99 units on a scale Standard Deviation 0.09	1.95 units on a scale Standard Deviation 0.21
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: performed paid work	1.82 units on a scale Standard Deviation 0.39	1.82 units on a scale Standard Deviation 0.39	1.75 units on a scale Standard Deviation 0.44
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: unable to do chores	1.83 units on a scale Standard Deviation 0.37	1.86 units on a scale Standard Deviation 0.35	1.80 units on a scale Standard Deviation 0.40
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: chores by housekeeper	1.96 units on a scale Standard Deviation 0.19	1.96 units on a scale Standard Deviation 0.20	1.97 units on a scale Standard Deviation 0.17
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Month 24: chores by family/friends	1.87 units on a scale Standard Deviation 0.34	1.88 units on a scale Standard Deviation 0.33	1.81 units on a scale Standard Deviation 0.39