| Primary | Modified Total Sharp Score (mTSS) at Month 6 | 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). | 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. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG00020.50± 40.58
- OG00118.85± 39.21
- OG00217.54± 29.96
|
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| |
| Primary | Change From Baseline at Month 6 in mTSS | 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. | FAS, imputation using LEP | Posted | | Least Squares Mean | Standard Error | score on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 | 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). | FAS. Missing values due to participant withdrawal were imputed using nonresponder imputation (NRI) method. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly | |
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| Primary | Absolute Blood Pressure (BP) Values (mmHg) | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Change From Baseline in BP Values (mmHg) | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | mmHg | | Months 1, 2, 3, 6, 9, 12, 15, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | mTSS Score at Baseline, Months 12 and 24 | 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). | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Months 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in mTSS Score at Months 12 and 24 | 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. | 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. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Months 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | 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. | FAS (LEP); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Number | | percentage of participants | | Months 6, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | 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. | | Posted | | Number | | percentage of participants | | Months 6, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Erosion Scores | 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. | FAS, imputation using LEP | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Months 6, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | JSN Scores | 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. | FAS, imputation using LEP | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Months 6, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Erosion Scores | 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. | FAS, imputation using LEP | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 6, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in JSN Scores | 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. | FAS, imputation using LEP | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 6, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants Achieving an ACR70 Response | 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. | | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants Achieving an ACR20 Response | 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. | | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants Achieving an ACR50 Response | 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. | | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Tender Joints Count (TJC) | 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). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | tender joints | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | CP-690,550 10 mg BID |
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| Secondary | Change From Baseline in TJC | 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). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Least Squares Mean | Standard Error | tender joints | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. |
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| Secondary | Swollen Joints Count (SJC) | 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). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | swollen joints | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. |
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| Secondary | Change From Baseline in SJC | 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). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Least Squares Mean | Standard Error | swollen joints | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. |
|
| Secondary | Patient Assessment of Arthritis Pain | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | mm | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in Patient Assessment of Arthritis Pain | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Least Squares Mean | Standard Error | mm | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Physician Global Assessment of Arthritis | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | mm | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in Physician Global Assessment of Arthritis | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Least Squares Mean | Standard Error | mm | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Patient Global Assessment of Arthritis | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | mm | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in Patient Global Assessment of Arthritis | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Least Squares Mean | Standard Error | mm | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | C-Reactive Protein | CRP measured in milligrams per liter (mg/L) | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | mg/L | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in CRP | Change from Baseline in CRP measured in mg/L. | | Posted | | Least Squares Mean | Standard Error | mg/L | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly | |
|
| Secondary | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly |
|
| Secondary | Change From Baseline in DAS28-3(CRP) | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in DAS28-4(ESR) | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With DAS28-3(CRP) ≤3.2 | 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. | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With DAS28-4(ESR) ≤3.2 | 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. | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With DAS28-3(CRP) <2.6 | 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. | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With DAS28-4(ESR) <2.6 | 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. | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | 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). | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | 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). | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly | |
|
| Secondary | Percentage of Participants With an ACR70 Response Sustained at Least 6 Months | 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. | | Posted | | Number | | percentage of participants | | Months 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 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. | | Posted | | Number | | percentage of participants | | Months 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 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. | | Posted | | Number | | percentage of participants | | Months 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 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. | | Posted | | Number | | percentage of participants | | Months 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 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. | | Posted | | Number | | percentage of participants | | Months 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 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. | | Posted | | Number | | percentage of participants | | Months 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Health Assessment Questionnaire Disability Index (HAQ-DI) | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | |
|
| Secondary | Change From Baseline in HAQ-DI Score | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
|
| Secondary | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | 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. | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
|
| Secondary | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | 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. | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
|
| Secondary | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | 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. | FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
|
| Secondary | Short Form 36 (SF-36) Mental Component Score | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly |
|
| Secondary | SF-36 Physical Component Score | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly |
|
| Secondary | Change From Baseline in SF-36 Mental Component Score | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly |
|
| Secondary | Change From Baseline in SF-36 Physical Component Score | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly |
|
| Secondary | SF-36 Domain Scores | 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). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in SF-36 Domain Scores | 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). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Work Limitation Questionnaire (WLQ) Score | 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). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in WLQ Scores | 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 items); 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). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | WLQ Work Loss Index Score | 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]). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 3, 6, and 12 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly |
|
| Secondary | Change From Baseline in WLQ Work Loss Index Score | 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]). | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a specific timepoint for each treatment group, respectively. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 3, 6, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15 or 20 mg, Weekly |
|
| Secondary | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 3, 6, 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
|
| Secondary | Change From Baseline in EQ-5D Health State Profile Utility Score | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoints for each group, respectively. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 3, 6, 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | events | | Baseline and Months 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | events | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | days | | Baseline and Months 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | days | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | hours per day | | Baseline and Months 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | hours per day | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Months 3, 6, 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Months 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly |
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| Secondary | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | MTX 10, 15, or 20 mg, Weekly |
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| Secondary | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | events | | Months 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | events | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | days | | Months 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | days | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | hours per day | | Months 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | hours per day | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Months 3, 6, 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, and 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | 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 | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Months 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Change From Baseline in MOS-SS at Months 1, 2, and 3 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Months 1, 2, and 3 | | | | ID | Title | Description |
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| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | 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. | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Months 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | 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 | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 1, 2, 3, 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Change From Baseline in FACIT-Fatigue Scale | 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 | FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Months 1, 2, 3, 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Change From Baseline in Heart Rate | | 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. | Posted | | Mean | Standard Deviation | beats per minute | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
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| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Change From Baseline in Temperature | | 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. | Posted | | Mean | Standard Deviation | degrees centigrade | | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | | | | ID | Title | Description |
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| OG000 | CP-690,550 5 mg BID | 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. | | OG001 | 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. | | OG002 | 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. |
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