Rheumatoid Arthritis
Conditions
Keywords
Long term open label study in Japan, CP-690, 550, tofacitinib
Brief summary
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another qualifying study of CP-690,550.
Interventions
DRUGCP-690,550
5 mg BID up to 10 mg BID until launch
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have completed their participation in a randomized qualifying study of CP-690,550 for the treatment of rheumatoid arthritis
Exclusion criteria
* Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Week 288 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | ACR70 response: greater than or equal to (\>=) 70 percent (%) improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in Patient Global Assessment of Arthritis | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in Physician Global Assessment of Arthritis | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in Patient Assessment of Arthritis Pain | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in Tender/Painful Joint Counts | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | This was carried out on 68 joints. Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in Swollen Joint Counts | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 | ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96 | 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). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement. Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
Countries
Japan
Participant flow
Pre-assignment details
Participants received study drug (CP-690,550 or placebo) in the precedent study A3921039 (NCT00603512) for 12 weeks, A3921040 (NCT00687193) for 12 weeks, or A3921044 (NCT00847613) for 2 years.
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 5 mg BID CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | 381 |
| CP-690,550 10 mg BID CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | 105 |
| Total | 486 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 99 | 24 |
| Overall Study | Lack of Efficacy | 3 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Not assigned treatment | 1 | 0 |
| Overall Study | Other | 22 | 7 |
| Overall Study | Withdrawal by Subject | 15 | 5 |
Baseline characteristics
| Characteristic | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 11.2 | 49.3 years STANDARD_DEVIATION 11.7 | 52.6 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 318 Participants | 86 Participants | 404 Participants |
| Sex: Female, Male Male | 63 Participants | 19 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 345 / 381 | 101 / 105 | 446 / 486 |
| serious Total, serious adverse events | 111 / 381 | 28 / 105 | 139 / 486 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.
Time frame: Baseline up to Week 288
Population: Safety analysis set: all participants who received at least 1 dose of study medication in current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Number of participants with AEs (including SAEs) | 371 Particiants |
| CP-690,550 5 mg BID | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Number of participants with SAEs | 111 Particiants |
| CP-690,550 10 mg BID | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Number of participants with AEs (including SAEs) | 105 Particiants |
| CP-690,550 10 mg BID | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Number of participants with SAEs | 28 Particiants |
| Total | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Number of participants with AEs (including SAEs) | 476 Particiants |
| Total | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Number of participants with SAEs | 139 Particiants |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 24 (n=357, 104, 461) | 4.95 Units on a scale | Standard Error 0.67 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 192 (n=138, 42, 180) | 2.05 Units on a scale | Standard Error 0.99 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 120 (n=242, 80, 322) | 3.79 Units on a scale | Standard Error 0.8 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 12 (n=370, 105, 475) | 5.13 Units on a scale | Standard Error 0.63 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 168 (n=213, 70, 283) | 3.64 Units on a scale | Standard Error 0.8 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 144 (n=224, 76, 300) | 3.57 Units on a scale | Standard Error 0.84 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 264 (n=59, 5, 64) | 2.59 Units on a scale | Standard Error 1.42 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 48 (n=331, 102, 433) | 4.56 Units on a scale | Standard Error 0.66 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 240 (n=65, 5, 70) | 2.41 Units on a scale | Standard Error 1.27 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 72 (n=315, 99, 414) | 3.63 Units on a scale | Standard Error 0.69 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 288 (n=3, 0, 3) | 18.64 Units on a scale | Standard Error 4.01 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 216 (n=76, 13, 89) | 1.49 Units on a scale | Standard Error 1.29 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 96 (n=281, 87, 368) | 3.88 Units on a scale | Standard Error 0.68 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 48 (n=331, 102, 433) | 4.45 Units on a scale | Standard Error 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 12 (n=370, 105, 475) | 4.82 Units on a scale | Standard Error 1.01 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 24 (n=357, 104, 461) | 3.38 Units on a scale | Standard Error 1.26 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 72 (n=315, 99, 414) | 4.15 Units on a scale | Standard Error 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 96 (n=281, 87, 368) | 4.53 Units on a scale | Standard Error 1.25 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 120 (n=242, 80, 322) | 3.68 Units on a scale | Standard Error 1.37 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 144 (n=224, 76, 300) | 2.24 Units on a scale | Standard Error 1.4 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 168 (n=213, 70, 283) | 2.45 Units on a scale | Standard Error 1.41 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 192 (n=138, 42, 180) | 3.44 Units on a scale | Standard Error 1.8 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 216 (n=76, 13, 89) | 3.14 Units on a scale | Standard Error 3.04 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 240 (n=65, 5, 70) | -0.04 Units on a scale | Standard Error 1.81 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 264 (n=59, 5, 64) | -2.25 Units on a scale | Standard Error 1.41 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 192 (n=138, 42, 180) | 2.38 Units on a scale | Standard Error 0.86 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 72 (n=315, 99, 414) | 3.75 Units on a scale | Standard Error 0.59 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 264 (n=59, 5, 64) | 2.21 Units on a scale | Standard Error 1.32 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 216 (n=76, 13, 89) | 1.73 Units on a scale | Standard Error 1.18 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 48 (n=331, 102, 433) | 4.54 Units on a scale | Standard Error 0.56 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 12 (n=370, 105, 475) | 5.06 Units on a scale | Standard Error 0.54 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 240 (n=65, 5, 70) | 2.23 Units on a scale | Standard Error 1.19 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 144 (n=224, 76, 300) | 3.23 Units on a scale | Standard Error 0.72 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 120 (n=242, 80, 322) | 3.76 Units on a scale | Standard Error 0.69 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 24 (n=357, 104, 461) | 4.60 Units on a scale | Standard Error 0.59 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 168 (n=213, 70, 283) | 3.35 Units on a scale | Standard Error 0.7 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 96 (n=281, 87, 368) | 4.03 Units on a scale | Standard Error 0.6 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | Week 288 (n=3, 0, 3) | 18.64 Units on a scale | Standard Error 4.01 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 264 (n=59, 5, 64) | 8.72 Units on a scale | Standard Error 1.03 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 192 (n=138, 42, 180) | 9.51 Units on a scale | Standard Error 0.65 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 120 (n=242, 80, 322) | 9.66 Units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 48 (n=331, 102, 433) | 9.75 Units on a scale | Standard Error 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 168 (n=213, 70, 283) | 9.51 Units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 144 (n=224, 76, 300) | 9.26 Units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 12 (n=370, 105, 475) | 8.44 Units on a scale | Standard Error 0.39 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 24 (n=357, 104, 461) | 9.39 Units on a scale | Standard Error 0.38 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 240 (n=65, 5, 70) | 9.00 Units on a scale | Standard Error 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 72 (n=315, 99, 414) | 9.72 Units on a scale | Standard Error 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 288 (n=3, 0, 3) | 6.87 Units on a scale | Standard Error 1.88 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 216 (n=76, 13, 89) | 9.59 Units on a scale | Standard Error 0.88 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 96 (n=281, 87, 368) | 9.35 Units on a scale | Standard Error 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 144 (n=224, 76, 300) | 8.60 Units on a scale | Standard Error 0.92 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 12 (n=370, 105, 475) | 6.09 Units on a scale | Standard Error 0.68 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 24 (n=357, 104, 461) | 7.56 Units on a scale | Standard Error 0.7 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 48 (n=331, 102, 433) | 8.24 Units on a scale | Standard Error 0.72 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 72 (n=315, 99, 414) | 8.21 Units on a scale | Standard Error 0.76 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 96 (n=281, 87, 368) | 8.93 Units on a scale | Standard Error 0.77 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 120 (n=242, 80, 322) | 8.79 Units on a scale | Standard Error 0.92 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 168 (n=213, 70, 283) | 7.86 Units on a scale | Standard Error 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 192 (n=138, 42, 180) | 8.56 Units on a scale | Standard Error 1.18 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 216 (n=76, 13, 89) | 5.37 Units on a scale | Standard Error 1.93 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 240 (n=65, 5, 70) | 1.91 Units on a scale | Standard Error 2.87 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 264 (n=59, 5, 64) | 2.31 Units on a scale | Standard Error 2.27 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 192 (n=138, 42, 180) | 9.29 Units on a scale | Standard Error 0.57 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 72 (n=315, 99, 414) | 9.36 Units on a scale | Standard Error 0.37 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 264 (n=59, 5, 64) | 8.22 Units on a scale | Standard Error 0.99 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 216 (n=76, 13, 89) | 8.97 Units on a scale | Standard Error 0.82 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 48 (n=331, 102, 433) | 9.39 Units on a scale | Standard Error 0.37 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 12 (n=370, 105, 475) | 7.92 Units on a scale | Standard Error 0.34 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 240 (n=65, 5, 70) | 8.49 Units on a scale | Standard Error 0.91 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 144 (n=224, 76, 300) | 9.09 Units on a scale | Standard Error 0.47 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 120 (n=242, 80, 322) | 9.45 Units on a scale | Standard Error 0.43 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 24 (n=357, 104, 461) | 8.98 Units on a scale | Standard Error 0.34 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 168 (n=213, 70, 283) | 9.10 Units on a scale | Standard Error 0.48 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 96 (n=281, 87, 368) | 9.25 Units on a scale | Standard Error 0.41 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | Week 288 (n=3, 0, 3) | 6.87 Units on a scale | Standard Error 1.88 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 72 (n=315, 99, 414) | 11.96 Units on a scale | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 24 (n=357, 104, 461) | 11.87 Units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 120 (n=242, 80, 322) | 11.98 Units on a scale | Standard Error 0.62 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 264 (n=59, 5, 64) | 11.27 Units on a scale | Standard Error 1.28 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 240 (n=65, 5, 70) | 11.34 Units on a scale | Standard Error 1.04 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 144 (n=224, 76, 300) | 11.51 Units on a scale | Standard Error 0.68 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 12 (n=370, 105, 475) | 11.40 Units on a scale | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 288 (n=3, 0, 3) | 7.08 Units on a scale | Standard Error 5.6 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 168 (n=213, 70, 283) | 11.82 Units on a scale | Standard Error 0.65 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 216 (n=76, 13, 89) | 12.43 Units on a scale | Standard Error 1.03 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 48 (n=331, 102, 433) | 12.19 Units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 192 (n=138, 42, 180) | 11.19 Units on a scale | Standard Error 0.85 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 96 (n=281, 87, 368) | 11.35 Units on a scale | Standard Error 0.59 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 192 (n=138, 42, 180) | 11.43 Units on a scale | Standard Error 1.57 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 216 (n=76, 13, 89) | 8.52 Units on a scale | Standard Error 2.37 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 240 (n=65, 5, 70) | 5.25 Units on a scale | Standard Error 2.63 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 72 (n=315, 99, 414) | 9.92 Units on a scale | Standard Error 0.81 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 264 (n=59, 5, 64) | 4.50 Units on a scale | Standard Error 2.87 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 96 (n=281, 87, 368) | 11.60 Units on a scale | Standard Error 1.04 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 120 (n=242, 80, 322) | 10.42 Units on a scale | Standard Error 1.08 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 24 (n=357, 104, 461) | 9.63 Units on a scale | Standard Error 0.79 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 144 (n=224, 76, 300) | 11.15 Units on a scale | Standard Error 1.04 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 12 (n=370, 105, 475) | 8.13 Units on a scale | Standard Error 0.77 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 168 (n=213, 70, 283) | 11.07 Units on a scale | Standard Error 1.11 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 48 (n=331, 102, 433) | 10.65 Units on a scale | Standard Error 0.75 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 288 (n=3, 0, 3) | 7.08 Units on a scale | Standard Error 5.6 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 12 (n=370, 105, 475) | 10.40 Units on a scale | Standard Error 0.41 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 24 (n=357, 104, 461) | 11.36 Units on a scale | Standard Error 0.43 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 72 (n=315, 99, 414) | 11.47 Units on a scale | Standard Error 0.47 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 96 (n=281, 87, 368) | 11.41 Units on a scale | Standard Error 0.51 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 120 (n=242, 80, 322) | 11.60 Units on a scale | Standard Error 0.54 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 144 (n=224, 76, 300) | 11.42 Units on a scale | Standard Error 0.57 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 168 (n=213, 70, 283) | 11.63 Units on a scale | Standard Error 0.56 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 192 (n=138, 42, 180) | 11.25 Units on a scale | Standard Error 0.75 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 216 (n=76, 13, 89) | 11.86 Units on a scale | Standard Error 0.95 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 240 (n=65, 5, 70) | 10.90 Units on a scale | Standard Error 0.99 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 264 (n=59, 5, 64) | 10.74 Units on a scale | Standard Error 1.22 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | Week 48 (n=331, 102, 433) | 11.83 Units on a scale | Standard Error 0.44 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 264 (n=59, 5, 64) | 4.12 Units on a scale | Standard Error 1.01 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 192 (n=138, 42, 180) | 4.72 Units on a scale | Standard Error 0.61 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 120 (n=242, 80, 322) | 5.86 Units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 48 (n=331, 102, 433) | 6.40 Units on a scale | Standard Error 0.4 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 168 (n=213, 70, 283) | 5.82 Units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 144 (n=224, 76, 300) | 5.37 Units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 12 (n=370, 105, 475) | 6.07 Units on a scale | Standard Error 0.38 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 24 (n=357, 104, 461) | 6.38 Units on a scale | Standard Error 0.39 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 240 (n=65, 5, 70) | 4.39 Units on a scale | Standard Error 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 72 (n=315, 99, 414) | 6.29 Units on a scale | Standard Error 0.42 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 288 (n=3, 0, 3) | -0.94 Units on a scale | Standard Error 4.23 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 216 (n=76, 13, 89) | 3.73 Units on a scale | Standard Error 0.87 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 96 (n=281, 87, 368) | 6.00 Units on a scale | Standard Error 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 144 (n=224, 76, 300) | 4.38 Units on a scale | Standard Error 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 12 (n=370, 105, 475) | 4.24 Units on a scale | Standard Error 0.7 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 24 (n=357, 104, 461) | 5.00 Units on a scale | Standard Error 0.58 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 48 (n=331, 102, 433) | 5.20 Units on a scale | Standard Error 0.67 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 72 (n=315, 99, 414) | 5.35 Units on a scale | Standard Error 0.63 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 96 (n=281, 87, 368) | 4.82 Units on a scale | Standard Error 0.73 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 120 (n=242, 80, 322) | 5.36 Units on a scale | Standard Error 0.82 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 168 (n=213, 70, 283) | 3.93 Units on a scale | Standard Error 0.87 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 192 (n=138, 42, 180) | 4.10 Units on a scale | Standard Error 1.05 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 216 (n=76, 13, 89) | 1.59 Units on a scale | Standard Error 1.31 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 240 (n=65, 5, 70) | -1.50 Units on a scale | Standard Error 1.9 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 264 (n=59, 5, 64) | -1.03 Units on a scale | Standard Error 2.17 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 192 (n=138, 42, 180) | 4.57 Units on a scale | Standard Error 0.53 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 72 (n=315, 99, 414) | 6.06 Units on a scale | Standard Error 0.35 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 264 (n=59, 5, 64) | 3.72 Units on a scale | Standard Error 0.96 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 216 (n=76, 13, 89) | 3.42 Units on a scale | Standard Error 0.77 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 48 (n=331, 102, 433) | 6.12 Units on a scale | Standard Error 0.34 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 12 (n=370, 105, 475) | 5.67 Units on a scale | Standard Error 0.34 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 240 (n=65, 5, 70) | 3.97 Units on a scale | Standard Error 0.92 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 144 (n=224, 76, 300) | 5.12 Units on a scale | Standard Error 0.47 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 120 (n=242, 80, 322) | 5.74 Units on a scale | Standard Error 0.42 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 24 (n=357, 104, 461) | 6.07 Units on a scale | Standard Error 0.33 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 168 (n=213, 70, 283) | 5.35 Units on a scale | Standard Error 0.46 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 96 (n=281, 87, 368) | 5.72 Units on a scale | Standard Error 0.38 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | Week 288 (n=3, 0, 3) | -0.94 Units on a scale | Standard Error 4.23 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 264 (n=59, 5, 64) | 4.18 Units on a scale | Standard Error 1.34 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 192 (n=138, 42, 180) | 3.77 Units on a scale | Standard Error 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 120 (n=242, 80, 322) | 5.56 Units on a scale | Standard Error 0.77 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 48 (n=331, 102, 433) | 5.73 Units on a scale | Standard Error 0.64 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 168 (n=213, 70, 283) | 5.12 Units on a scale | Standard Error 0.76 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 144 (n=224, 76, 300) | 5.10 Units on a scale | Standard Error 0.84 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 12 (n=370, 105, 475) | 6.27 Units on a scale | Standard Error 0.63 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 24 (n=357, 104, 461) | 6.22 Units on a scale | Standard Error 0.65 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 240 (n=65, 5, 70) | 3.75 Units on a scale | Standard Error 1.2 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 72 (n=315, 99, 414) | 4.77 Units on a scale | Standard Error 0.7 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 288 (n=3, 0, 3) | 14.78 Units on a scale | Standard Error 7.56 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 216 (n=76, 13, 89) | 2.66 Units on a scale | Standard Error 1.21 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 96 (n=281, 87, 368) | 5.23 Units on a scale | Standard Error 0.68 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 144 (n=224, 76, 300) | 4.37 Units on a scale | Standard Error 1.34 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 12 (n=370, 105, 475) | 5.38 Units on a scale | Standard Error 1.04 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 24 (n=357, 104, 461) | 3.84 Units on a scale | Standard Error 1.17 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 48 (n=331, 102, 433) | 5.35 Units on a scale | Standard Error 1.02 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 72 (n=315, 99, 414) | 5.48 Units on a scale | Standard Error 1.04 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 96 (n=281, 87, 368) | 5.89 Units on a scale | Standard Error 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 120 (n=242, 80, 322) | 5.26 Units on a scale | Standard Error 1.31 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 168 (n=213, 70, 283) | 3.76 Units on a scale | Standard Error 1.29 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 192 (n=138, 42, 180) | 5.21 Units on a scale | Standard Error 1.75 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 216 (n=76, 13, 89) | 4.26 Units on a scale | Standard Error 3.04 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 240 (n=65, 5, 70) | 3.32 Units on a scale | Standard Error 2.04 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 264 (n=59, 5, 64) | 0.00 Units on a scale | Standard Error 1.75 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 192 (n=138, 42, 180) | 4.11 Units on a scale | Standard Error 0.82 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 72 (n=315, 99, 414) | 4.94 Units on a scale | Standard Error 0.59 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 264 (n=59, 5, 64) | 3.85 Units on a scale | Standard Error 1.25 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 216 (n=76, 13, 89) | 2.89 Units on a scale | Standard Error 1.12 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 48 (n=331, 102, 433) | 5.64 Units on a scale | Standard Error 0.54 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 12 (n=370, 105, 475) | 6.08 Units on a scale | Standard Error 0.54 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 240 (n=65, 5, 70) | 3.72 Units on a scale | Standard Error 1.12 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 144 (n=224, 76, 300) | 4.91 Units on a scale | Standard Error 0.71 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 120 (n=242, 80, 322) | 5.49 Units on a scale | Standard Error 0.67 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 24 (n=357, 104, 461) | 5.69 Units on a scale | Standard Error 0.57 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 168 (n=213, 70, 283) | 4.79 Units on a scale | Standard Error 0.66 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 96 (n=281, 87, 368) | 5.38 Units on a scale | Standard Error 0.59 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | Week 288 (n=3, 0, 3) | 14.78 Units on a scale | Standard Error 7.56 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 264 (n=59, 5, 64) | 8.85 Units on a scale | Standard Error 1.08 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 192 (n=138, 42, 180) | 9.43 Units on a scale | Standard Error 0.78 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 120 (n=242, 80, 322) | 9.12 Units on a scale | Standard Error 0.57 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 48 (n=331, 102, 433) | 9.06 Units on a scale | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 168 (n=213, 70, 283) | 9.01 Units on a scale | Standard Error 0.68 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 144 (n=224, 76, 300) | 8.85 Units on a scale | Standard Error 0.66 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 12 (n=370, 105, 475) | 7.87 Units on a scale | Standard Error 0.45 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 24 (n=357, 104, 461) | 8.67 Units on a scale | Standard Error 0.46 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 240 (n=65, 5, 70) | 8.91 Units on a scale | Standard Error 1 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 72 (n=315, 99, 414) | 9.10 Units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 288 (n=3, 0, 3) | 10.23 Units on a scale | Standard Error 1.18 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 216 (n=76, 13, 89) | 8.78 Units on a scale | Standard Error 0.98 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 96 (n=281, 87, 368) | 9.11 Units on a scale | Standard Error 0.55 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 144 (n=224, 76, 300) | 7.57 Units on a scale | Standard Error 1.18 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 12 (n=370, 105, 475) | 5.94 Units on a scale | Standard Error 0.76 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 24 (n=357, 104, 461) | 6.12 Units on a scale | Standard Error 1.01 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 48 (n=331, 102, 433) | 6.84 Units on a scale | Standard Error 1.05 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 72 (n=315, 99, 414) | 7.61 Units on a scale | Standard Error 0.93 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 96 (n=281, 87, 368) | 8.26 Units on a scale | Standard Error 0.88 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 120 (n=242, 80, 322) | 8.34 Units on a scale | Standard Error 1.09 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 168 (n=213, 70, 283) | 7.16 Units on a scale | Standard Error 1.36 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 192 (n=138, 42, 180) | 8.09 Units on a scale | Standard Error 1.25 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 216 (n=76, 13, 89) | 5.04 Units on a scale | Standard Error 2.27 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 240 (n=65, 5, 70) | 3.27 Units on a scale | Standard Error 1.9 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 264 (n=59, 5, 64) | 1.64 Units on a scale | Standard Error 1.98 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 192 (n=138, 42, 180) | 9.12 Units on a scale | Standard Error 0.66 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 72 (n=315, 99, 414) | 8.74 Units on a scale | Standard Error 0.45 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 264 (n=59, 5, 64) | 8.28 Units on a scale | Standard Error 1.03 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 216 (n=76, 13, 89) | 8.23 Units on a scale | Standard Error 0.91 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 48 (n=331, 102, 433) | 8.54 Units on a scale | Standard Error 0.45 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 12 (n=370, 105, 475) | 7.45 Units on a scale | Standard Error 0.39 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 240 (n=65, 5, 70) | 8.51 Units on a scale | Standard Error 0.95 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 144 (n=224, 76, 300) | 8.53 Units on a scale | Standard Error 0.57 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 120 (n=242, 80, 322) | 8.92 Units on a scale | Standard Error 0.51 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 24 (n=357, 104, 461) | 8.10 Units on a scale | Standard Error 0.42 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 168 (n=213, 70, 283) | 8.55 Units on a scale | Standard Error 0.61 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 96 (n=281, 87, 368) | 8.91 Units on a scale | Standard Error 0.47 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | Week 288 (n=3, 0, 3) | 10.23 Units on a scale | Standard Error 1.18 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 264 (n=59, 5, 64) | 5.07 Units on a scale | Standard Error 1.74 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 192 (n=138, 42, 180) | 4.31 Units on a scale | Standard Error 1.23 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 120 (n=242, 80, 322) | 5.68 Units on a scale | Standard Error 0.9 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 48 (n=331, 102, 433) | 7.26 Units on a scale | Standard Error 0.75 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 168 (n=213, 70, 283) | 5.90 Units on a scale | Standard Error 0.89 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 144 (n=224, 76, 300) | 5.39 Units on a scale | Standard Error 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 12 (n=370, 105, 475) | 6.65 Units on a scale | Standard Error 0.65 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 24 (n=357, 104, 461) | 6.88 Units on a scale | Standard Error 0.73 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 240 (n=65, 5, 70) | 4.72 Units on a scale | Standard Error 1.66 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 72 (n=315, 99, 414) | 6.02 Units on a scale | Standard Error 0.78 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 288 (n=3, 0, 3) | 22.71 Units on a scale | Standard Error 5.78 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 216 (n=76, 13, 89) | 4.33 Units on a scale | Standard Error 1.55 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 96 (n=281, 87, 368) | 6.04 Units on a scale | Standard Error 0.79 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 144 (n=224, 76, 300) | 3.74 Units on a scale | Standard Error 1.56 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 12 (n=370, 105, 475) | 4.98 Units on a scale | Standard Error 1.19 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 24 (n=357, 104, 461) | 4.40 Units on a scale | Standard Error 1.41 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 48 (n=331, 102, 433) | 5.49 Units on a scale | Standard Error 1.29 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 72 (n=315, 99, 414) | 5.54 Units on a scale | Standard Error 1.28 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 96 (n=281, 87, 368) | 5.96 Units on a scale | Standard Error 1.43 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 120 (n=242, 80, 322) | 3.98 Units on a scale | Standard Error 1.4 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 168 (n=213, 70, 283) | 4.43 Units on a scale | Standard Error 1.49 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 192 (n=138, 42, 180) | 4.42 Units on a scale | Standard Error 1.91 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 216 (n=76, 13, 89) | 3.49 Units on a scale | Standard Error 2.76 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 240 (n=65, 5, 70) | -0.76 Units on a scale | Standard Error 4.22 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 264 (n=59, 5, 64) | -0.76 Units on a scale | Standard Error 4.22 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 192 (n=138, 42, 180) | 4.33 Units on a scale | Standard Error 1.04 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 72 (n=315, 99, 414) | 5.91 Units on a scale | Standard Error 0.67 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 264 (n=59, 5, 64) | 4.61 Units on a scale | Standard Error 1.64 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 216 (n=76, 13, 89) | 4.21 Units on a scale | Standard Error 1.38 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 48 (n=331, 102, 433) | 6.85 Units on a scale | Standard Error 0.65 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 12 (n=370, 105, 475) | 6.28 Units on a scale | Standard Error 0.57 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 240 (n=65, 5, 70) | 4.33 Units on a scale | Standard Error 1.58 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 144 (n=224, 76, 300) | 4.97 Units on a scale | Standard Error 0.82 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 120 (n=242, 80, 322) | 5.26 Units on a scale | Standard Error 0.76 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 24 (n=357, 104, 461) | 6.32 Units on a scale | Standard Error 0.65 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 168 (n=213, 70, 283) | 5.54 Units on a scale | Standard Error 0.76 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 96 (n=281, 87, 368) | 6.02 Units on a scale | Standard Error 0.69 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | Week 288 (n=3, 0, 3) | 22.71 Units on a scale | Standard Error 5.78 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 264 (n=59, 5, 64) | 6.15 Units on a scale | Standard Error 1.58 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 192 (n=138, 42, 180) | 6.59 Units on a scale | Standard Error 1.01 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 120 (n=242, 80, 322) | 7.69 Units on a scale | Standard Error 0.75 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 48 (n=331, 102, 433) | 8.38 Units on a scale | Standard Error 0.64 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 168 (n=213, 70, 283) | 7.38 Units on a scale | Standard Error 0.77 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 144 (n=224, 76, 300) | 7.21 Units on a scale | Standard Error 0.8 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 12 (n=370, 105, 475) | 7.31 Units on a scale | Standard Error 0.57 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 24 (n=357, 104, 461) | 8.21 Units on a scale | Standard Error 0.59 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 240 (n=65, 5, 70) | 6.13 Units on a scale | Standard Error 1.56 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 72 (n=315, 99, 414) | 7.23 Units on a scale | Standard Error 0.67 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 288 (n=3, 0, 3) | 22.27 Units on a scale | Standard Error 5.22 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 216 (n=76, 13, 89) | 6.53 Units on a scale | Standard Error 1.37 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 96 (n=281, 87, 368) | 7.24 Units on a scale | Standard Error 0.7 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 144 (n=224, 76, 300) | 6.56 Units on a scale | Standard Error 1.23 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 12 (n=370, 105, 475) | 5.48 Units on a scale | Standard Error 1 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 24 (n=357, 104, 461) | 6.29 Units on a scale | Standard Error 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 48 (n=331, 102, 433) | 7.77 Units on a scale | Standard Error 0.92 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 72 (n=315, 99, 414) | 7.47 Units on a scale | Standard Error 1.08 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 96 (n=281, 87, 368) | 8.15 Units on a scale | Standard Error 1.16 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 120 (n=242, 80, 322) | 6.77 Units on a scale | Standard Error 1.1 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 168 (n=213, 70, 283) | 5.42 Units on a scale | Standard Error 1.41 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 192 (n=138, 42, 180) | 6.70 Units on a scale | Standard Error 1.57 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 216 (n=76, 13, 89) | 4.59 Units on a scale | Standard Error 2.53 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 240 (n=65, 5, 70) | -0.48 Units on a scale | Standard Error 2.86 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 264 (n=59, 5, 64) | 0.95 Units on a scale | Standard Error 2.68 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 192 (n=138, 42, 180) | 6.61 Units on a scale | Standard Error 0.86 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 72 (n=315, 99, 414) | 7.29 Units on a scale | Standard Error 0.57 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 264 (n=59, 5, 64) | 5.74 Units on a scale | Standard Error 1.48 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 216 (n=76, 13, 89) | 6.25 Units on a scale | Standard Error 1.22 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 48 (n=331, 102, 433) | 8.23 Units on a scale | Standard Error 0.53 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 12 (n=370, 105, 475) | 6.90 Units on a scale | Standard Error 0.5 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 240 (n=65, 5, 70) | 5.66 Units on a scale | Standard Error 1.48 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 144 (n=224, 76, 300) | 7.05 Units on a scale | Standard Error 0.67 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 120 (n=242, 80, 322) | 7.46 Units on a scale | Standard Error 0.63 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 24 (n=357, 104, 461) | 7.77 Units on a scale | Standard Error 0.51 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 168 (n=213, 70, 283) | 6.90 Units on a scale | Standard Error 0.68 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 96 (n=281, 87, 368) | 7.46 Units on a scale | Standard Error 0.6 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | Week 288 (n=3, 0, 3) | 22.27 Units on a scale | Standard Error 5.22 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 96 (n=281, 87, 368) | 4.88 Units on a scale | Standard Error 0.67 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 192 (n=138, 42, 180) | 4.56 Units on a scale | Standard Error 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 120 (n=242, 80, 322) | 5.20 Units on a scale | Standard Error 0.76 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 12 (n=370, 105, 475) | 4.99 Units on a scale | Standard Error 0.6 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 168 (n=213, 70, 283) | 4.72 Units on a scale | Standard Error 0.79 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 144 (n=224, 76, 300) | 5.23 Units on a scale | Standard Error 0.77 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 264 (n=59, 5, 64) | 4.47 Units on a scale | Standard Error 1.45 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 48 (n=331, 102, 433) | 5.28 Units on a scale | Standard Error 0.64 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 288 (n=3, 0, 3) | 14.34 Units on a scale | Standard Error 9.49 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 240 (n=65, 5, 70) | 4.88 Units on a scale | Standard Error 1.41 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 72 (n=315, 99, 414) | 4.81 Units on a scale | Standard Error 0.64 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 24 (n=357, 104, 461) | 5.57 Units on a scale | Standard Error 0.62 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 216 (n=76, 13, 89) | 4.53 Units on a scale | Standard Error 1.23 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 96 (n=281, 87, 368) | 6.43 Units on a scale | Standard Error 1.19 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 12 (n=370, 105, 475) | 5.17 Units on a scale | Standard Error 1.09 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 24 (n=357, 104, 461) | 4.96 Units on a scale | Standard Error 1.25 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 48 (n=331, 102, 433) | 5.27 Units on a scale | Standard Error 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 72 (n=315, 99, 414) | 4.78 Units on a scale | Standard Error 1.31 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 120 (n=242, 80, 322) | 5.98 Units on a scale | Standard Error 1.11 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 144 (n=224, 76, 300) | 3.33 Units on a scale | Standard Error 1.39 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 168 (n=213, 70, 283) | 3.84 Units on a scale | Standard Error 1.43 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 192 (n=138, 42, 180) | 5.63 Units on a scale | Standard Error 1.36 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 216 (n=76, 13, 89) | 3.31 Units on a scale | Standard Error 2.48 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 240 (n=65, 5, 70) | 0.00 Units on a scale | Standard Error 0 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 264 (n=59, 5, 64) | -2.15 Units on a scale | Standard Error 2.15 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 192 (n=138, 42, 180) | 4.81 Units on a scale | Standard Error 0.8 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 72 (n=315, 99, 414) | 4.81 Units on a scale | Standard Error 0.58 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 264 (n=59, 5, 64) | 3.95 Units on a scale | Standard Error 1.37 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 216 (n=76, 13, 89) | 4.35 Units on a scale | Standard Error 1.1 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 48 (n=331, 102, 433) | 5.28 Units on a scale | Standard Error 0.55 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 12 (n=370, 105, 475) | 5.03 Units on a scale | Standard Error 0.52 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 240 (n=65, 5, 70) | 4.53 Units on a scale | Standard Error 1.32 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 144 (n=224, 76, 300) | 4.75 Units on a scale | Standard Error 0.67 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 120 (n=242, 80, 322) | 5.39 Units on a scale | Standard Error 0.63 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 24 (n=357, 104, 461) | 5.44 Units on a scale | Standard Error 0.56 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 168 (n=213, 70, 283) | 4.50 Units on a scale | Standard Error 0.69 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 96 (n=281, 87, 368) | 5.25 Units on a scale | Standard Error 0.58 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | Week 288 (n=3, 0, 3) | 14.34 Units on a scale | Standard Error 9.49 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 288 (n=3, 0, 3) | 14.97 Units on a scale | Standard Error 8.64 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 192 (n=138, 42, 180) | 5.40 Units on a scale | Standard Error 0.92 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 120 (n=242, 80, 322) | 6.49 Units on a scale | Standard Error 0.7 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 264 (n=59, 5, 64) | 4.72 Units on a scale | Standard Error 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 168 (n=213, 70, 283) | 6.58 Units on a scale | Standard Error 0.72 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 144 (n=224, 76, 300) | 6.27 Units on a scale | Standard Error 0.75 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 72 (n=315, 99, 414) | 7.02 Units on a scale | Standard Error 0.61 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 48 (n=331, 102, 433) | 6.83 Units on a scale | Standard Error 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 12 (n=370, 105, 475) | 7.37 Units on a scale | Standard Error 0.59 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 240 (n=65, 5, 70) | 5.11 Units on a scale | Standard Error 1.21 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 24 (n=357, 104, 461) | 7.24 Units on a scale | Standard Error 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 216 (n=76, 13, 89) | 5.04 Units on a scale | Standard Error 1.18 |
| CP-690,550 5 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 96 (n=281, 87, 368) | 6.78 Units on a scale | Standard Error 0.61 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 12 (n=370, 105, 475) | 6.61 Units on a scale | Standard Error 0.9 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 24 (n=357, 104, 461) | 6.25 Units on a scale | Standard Error 0.97 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 48 (n=331, 102, 433) | 7.22 Units on a scale | Standard Error 0.89 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 72 (n=315, 99, 414) | 6.44 Units on a scale | Standard Error 0.98 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 96 (n=281, 87, 368) | 6.19 Units on a scale | Standard Error 1.11 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 120 (n=242, 80, 322) | 6.96 Units on a scale | Standard Error 1.26 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 144 (n=224, 76, 300) | 5.51 Units on a scale | Standard Error 1.15 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 168 (n=213, 70, 283) | 4.75 Units on a scale | Standard Error 1.27 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 192 (n=138, 42, 180) | 5.70 Units on a scale | Standard Error 1.62 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 216 (n=76, 13, 89) | 5.30 Units on a scale | Standard Error 2.47 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 240 (n=65, 5, 70) | -0.60 Units on a scale | Standard Error 3.05 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 264 (n=59, 5, 64) | -1.80 Units on a scale | Standard Error 3.36 |
| CP-690,550 10 mg BID | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 192 (n=138, 42, 180) | 5.47 Units on a scale | Standard Error 0.8 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 72 (n=315, 99, 414) | 6.88 Units on a scale | Standard Error 0.52 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 264 (n=59, 5, 64) | 4.21 Units on a scale | Standard Error 1.13 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 216 (n=76, 13, 89) | 5.08 Units on a scale | Standard Error 1.07 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 48 (n=331, 102, 433) | 6.92 Units on a scale | Standard Error 0.49 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 12 (n=370, 105, 475) | 7.20 Units on a scale | Standard Error 0.5 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 240 (n=65, 5, 70) | 4.70 Units on a scale | Standard Error 1.15 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 144 (n=224, 76, 300) | 6.08 Units on a scale | Standard Error 0.63 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 120 (n=242, 80, 322) | 6.61 Units on a scale | Standard Error 0.61 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 24 (n=357, 104, 461) | 7.02 Units on a scale | Standard Error 0.5 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 168 (n=213, 70, 283) | 6.12 Units on a scale | Standard Error 0.63 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 96 (n=281, 87, 368) | 6.64 Units on a scale | Standard Error 0.54 |
| Total | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | Week 288 (n=3, 0, 3) | 14.97 Units on a scale | Standard Error 8.64 |
Secondary
Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 48 (n=331, 102, 433) | -2.92 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 (n=372, 105, 477) | -2.55 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 156 (n=219, 72, 291) | -2.84 Units on a scale | Standard Error 0.08 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 60 (n=322, 102, 424) | -2.92 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 (n= 378, 105, 483) | -2.44 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 144 (n=224, 76, 300) | -2.90 Units on a scale | Standard Error 0.08 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 72 (n=315, 99, 414) | -2.93 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 252 (n=65, 5, 70) | -3.09 Units on a scale | Standard Error 0.14 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 132 (n=231, 79, 310) | -2.89 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 84 (n=309, 92, 401) | -2.98 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 216 (n=76, 13, 89) | -2.94 Units on a scale | Standard Error 0.12 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 120 (n=242, 80, 322) | -2.97 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 96 (n=281, 87, 368) | -2.95 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 240 (n=65, 5, 70) | -2.97 Units on a scale | Standard Error 0.13 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 108 (n=259, 83, 342) | -2.93 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 204 (n=109, 30, 139) | -2.95 Units on a scale | Standard Error 0.11 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 (n=371, 105, 476) | -2.68 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 264 (n=58, 5, 63) | -3.13 Units on a scale | Standard Error 0.15 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 (n=370, 105, 475) | -2.75 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 288 (n=3, 0, 3) | -2.67 Units on a scale | Standard Error 0.27 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 192 (n=138, 42, 180) | -2.93 Units on a scale | Standard Error 0.09 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 24 (n=357, 104, 461) | -2.85 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 276 (n=22, 1, 23) | -3.24 Units on a scale | Standard Error 0.24 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 180 (n=180, 57, 237) | -2.92 Units on a scale | Standard Error 0.09 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 36 (n=337, 102, 439) | -2.92 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 228 (n=68, 5, 73) | -2.84 Units on a scale | Standard Error 0.17 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 168 (n=213, 70, 283) | -2.90 Units on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 216 (n=76, 13, 89) | -2.46 Units on a scale | Standard Error 0.34 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 240 (n=65, 5, 70) | -2.36 Units on a scale | Standard Error 0.57 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 252 (n=65, 5, 70) | -1.89 Units on a scale | Standard Error 0.42 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 (n= 378, 105, 483) | -1.90 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 (n=372, 105, 477) | -1.90 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 (n=371, 105, 476) | -2.06 Units on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 (n=370, 105, 475) | -1.97 Units on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 24 (n=357, 104, 461) | -2.29 Units on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 36 (n=337, 102, 439) | -2.45 Units on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 48 (n=331, 102, 433) | -2.58 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 60 (n=322, 102, 424) | -2.60 Units on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 72 (n=315, 99, 414) | -2.61 Units on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 84 (n=309, 92, 401) | -2.70 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 96 (n=281, 87, 368) | -2.69 Units on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 108 (n=259, 83, 342) | -2.64 Units on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 120 (n=242, 80, 322) | -2.60 Units on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 132 (n=231, 79, 310) | -2.66 Units on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 144 (n=224, 76, 300) | -2.68 Units on a scale | Standard Error 0.14 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 156 (n=219, 72, 291) | -2.70 Units on a scale | Standard Error 0.14 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 168 (n=213, 70, 283) | -2.68 Units on a scale | Standard Error 0.15 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 180 (n=180, 57, 237) | -2.80 Units on a scale | Standard Error 0.17 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 192 (n=138, 42, 180) | -2.84 Units on a scale | Standard Error 0.16 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 204 (n=109, 30, 139) | -3.05 Units on a scale | Standard Error 0.22 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 228 (n=68, 5, 73) | -2.38 Units on a scale | Standard Error 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 264 (n=58, 5, 63) | -1.86 Units on a scale | Standard Error 0.3 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 276 (n=22, 1, 23) | -1.50 Units on a scale | — |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 48 (n=331, 102, 433) | -2.84 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 240 (n=65, 5, 70) | -2.92 Units on a scale | Standard Error 0.13 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 156 (n=219, 72, 291) | -2.81 Units on a scale | Standard Error 0.07 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 36 (n=337, 102, 439) | -2.81 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 228 (n=68, 5, 73) | -2.81 Units on a scale | Standard Error 0.16 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 168 (n=213, 70, 283) | -2.84 Units on a scale | Standard Error 0.07 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 24 (n=357, 104, 461) | -2.72 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 252 (n=65, 5, 70) | -3.00 Units on a scale | Standard Error 0.14 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 180 (n=180, 57, 237) | -2.89 Units on a scale | Standard Error 0.08 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 (n=370, 105, 475) | -2.57 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 276 (n=22, 1, 23) | -3.16 Units on a scale | Standard Error 0.24 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 192 (n=138, 42, 180) | -2.91 Units on a scale | Standard Error 0.08 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 (n=372, 105, 477) | -2.41 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 264 (n=58, 5, 63) | -3.03 Units on a scale | Standard Error 0.14 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 204 (n=109, 30, 139) | -2.97 Units on a scale | Standard Error 0.1 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 96 (n=281, 87, 368) | -2.88 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 (n= 378, 105, 483) | -2.32 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 108 (n=259, 83, 342) | -2.86 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 84 (n=309, 92, 401) | -2.92 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 (n=371, 105, 476) | -2.55 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 120 (n=242, 80, 322) | -2.88 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 72 (n=315, 99, 414) | -2.86 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 216 (n=76, 13, 89) | -2.87 Units on a scale | Standard Error 0.12 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 132 (n=231, 79, 310) | -2.83 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 60 (n=322, 102, 424) | -2.85 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 288 (n=3, 0, 3) | -2.67 Units on a scale | Standard Error 0.27 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 144 (n=224, 76, 300) | -2.85 Units on a scale | Standard Error 0.07 |
Secondary
Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 (n= 378, 105, 483) | -2.60 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 168 (n=213, 70, 283) | -3.16 Units on a scale | Standard Error 0.09 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 84 (n=309, 92, 401) | -3.26 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 228 (n=68, 5, 73) | -3.08 Units on a scale | Standard Error 0.17 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 156 (n=218, 72, 290) | -3.08 Units on a scale | Standard Error 0.09 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 96 (n=281, 87, 368) | -3.21 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 (n=371, 104, 475) | -2.95 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 144 (n=224, 76, 300) | -3.17 Units on a scale | Standard Error 0.09 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 108 (n=259, 83, 342) | -3.22 Units on a scale | Standard Error 0.08 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 (n=372, 105, 477) | -2.77 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 132 (n=232, 79, 311) | -3.14 Units on a scale | Standard Error 0.08 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 120 (n=242, 79, 321) | -3.24 Units on a scale | Standard Error 0.08 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 216 (n=76, 13, 89) | -3.20 Units on a scale | Standard Error 0.13 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 (n=370, 105, 475) | -3.01 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 288 (n=3, 0, 3) | -2.95 Units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 24 (n=357, 104, 461) | -3.12 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 276 (n=21, 1, 22) | -3.34 Units on a scale | Standard Error 0.25 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 204 (n=109, 30, 139) | -3.24 Units on a scale | Standard Error 0.12 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 36 (n=339, 102, 441) | -3.18 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 264 (n=59, 5, 64) | -3.32 Units on a scale | Standard Error 0.15 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 192 (n=138, 42, 180) | -3.17 Units on a scale | Standard Error 0.11 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 48 (n=331, 102, 433) | -3.20 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 252 (n=65, 5, 70) | -3.33 Units on a scale | Standard Error 0.15 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 60 (n=323, 101, 424) | -3.25 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 240 (n=65, 5, 70) | -3.22 Units on a scale | Standard Error 0.15 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 180 (n=178, 56, 234) | -3.21 Units on a scale | Standard Error 0.1 |
| CP-690,550 5 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 72 (n=315, 99, 414) | -3.20 Units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 204 (n=109, 30, 139) | -3.35 Units on a scale | Standard Error 0.25 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 (n=372, 105, 477) | -1.95 Units on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 (n=371, 104, 475) | -2.14 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 (n=370, 105, 475) | -2.08 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 24 (n=357, 104, 461) | -2.42 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 36 (n=339, 102, 441) | -2.54 Units on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 48 (n=331, 102, 433) | -2.72 Units on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 60 (n=323, 101, 424) | -2.80 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 72 (n=315, 99, 414) | -2.83 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 84 (n=309, 92, 401) | -2.86 Units on a scale | Standard Error 0.14 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 96 (n=281, 87, 368) | -2.87 Units on a scale | Standard Error 0.14 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 108 (n=259, 83, 342) | -2.83 Units on a scale | Standard Error 0.15 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 120 (n=242, 79, 321) | -2.78 Units on a scale | Standard Error 0.14 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 132 (n=232, 79, 311) | -2.84 Units on a scale | Standard Error 0.15 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 144 (n=224, 76, 300) | -2.84 Units on a scale | Standard Error 0.16 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 156 (n=218, 72, 290) | -2.84 Units on a scale | Standard Error 0.16 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 168 (n=213, 70, 283) | -2.87 Units on a scale | Standard Error 0.17 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 180 (n=178, 56, 234) | -3.06 Units on a scale | Standard Error 0.19 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 192 (n=138, 42, 180) | -3.07 Units on a scale | Standard Error 0.19 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 (n= 378, 105, 483) | -1.94 Units on a scale | Standard Error 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 216 (n=76, 13, 89) | -2.44 Units on a scale | Standard Error 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 228 (n=68, 5, 73) | -2.25 Units on a scale | Standard Error 0.58 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 240 (n=65, 5, 70) | -2.61 Units on a scale | Standard Error 0.7 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 252 (n=65, 5, 70) | -1.81 Units on a scale | Standard Error 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 264 (n=59, 5, 64) | -2.09 Units on a scale | Standard Error 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 276 (n=21, 1, 22) | -2.15 Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 288 (n=3, 0, 3) | -2.95 Units on a scale | Standard Error 0.51 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 180 (n=178, 56, 234) | -3.18 Units on a scale | Standard Error 0.09 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 36 (n=339, 102, 441) | -3.03 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 252 (n=65, 5, 70) | -3.23 Units on a scale | Standard Error 0.15 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 192 (n=138, 42, 180) | -3.15 Units on a scale | Standard Error 0.09 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 24 (n=357, 104, 461) | -2.96 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 48 (n=331, 102, 433) | -3.08 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 (n=371, 104, 475) | -2.77 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 (n=372, 105, 477) | -2.59 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 216 (n=76, 13, 89) | -3.09 Units on a scale | Standard Error 0.13 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 (n= 378, 105, 483) | -2.45 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 264 (n=59, 5, 64) | -3.23 Units on a scale | Standard Error 0.14 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 228 (n=68, 5, 73) | -3.02 Units on a scale | Standard Error 0.16 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 120 (n=242, 79, 321) | -3.12 Units on a scale | Standard Error 0.07 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 108 (n=259, 83, 342) | -3.12 Units on a scale | Standard Error 0.07 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 276 (n=21, 1, 22) | -3.29 Units on a scale | Standard Error 0.24 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 132 (n=232, 79, 311) | -3.07 Units on a scale | Standard Error 0.07 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 96 (n=281, 87, 368) | -3.13 Units on a scale | Standard Error 0.07 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 (n=370, 105, 475) | -2.81 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 144 (n=224, 76, 300) | -3.09 Units on a scale | Standard Error 0.08 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 84 (n=309, 92, 401) | -3.17 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 240 (n=65, 5, 70) | -3.17 Units on a scale | Standard Error 0.14 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 156 (n=218, 72, 290) | -3.02 Units on a scale | Standard Error 0.08 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 72 (n=315, 99, 414) | -3.11 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 204 (n=109, 30, 139) | -3.26 Units on a scale | Standard Error 0.11 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 168 (n=213, 70, 283) | -3.09 Units on a scale | Standard Error 0.08 |
| Total | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 60 (n=323, 101, 424) | -3.15 Units on a scale | Standard Error 0.06 |
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (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, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 24 (n=357, 104, 461) | -0.69 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 (n=370, 105, 475) | -0.66 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 36 (n=339, 102, 441) | -0.70 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 48 (n=331, 102, 433) | -0.70 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 72 (n=315, 99, 414) | -0.72 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 108 (n=259, 84, 343) | -0.70 Units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 132 (n=232, 79, 311) | -0.70 Units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 156 (n=219, 72, 291) | -0.68 Units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 192 (n=138, 42, 180) | -0.69 Units on a scale | Standard Error 0.05 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 216 (n=76, 13, 89) | -0.62 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 228 (n=68, 5, 73) | -0.62 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 240 (n=65, 5, 70) | -0.66 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 252 (n=65, 5, 70) | -0.68 Units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 276 (n=22, 1, 23) | -0.83 Units on a scale | Standard Error 0.11 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 288 (n=3, 0, 3) | -0.96 Units on a scale | Standard Error 0.37 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 (n= 378, 105, 483) | -0.55 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 (n=372, 105, 477) | -0.61 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 (n=371, 105, 476) | -0.66 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 60 (n=323, 102, 425) | -0.71 Units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 84 (n=309, 92, 401) | -0.72 Units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 96 (n=281, 87, 368) | -0.72 Units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 120 (n=242, 80, 322) | -0.70 Units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 144 (n=224, 76, 300) | -0.67 Units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 168 (n=213, 70, 283) | -0.68 Units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 180 (n=180, 57, 237) | -0.70 Units on a scale | Standard Error 0.05 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 204 (n=109, 30, 139) | -0.67 Units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 264 (n=59, 5, 64) | -0.65 Units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 60 (n=323, 102, 425) | -0.57 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 156 (n=219, 72, 291) | -0.62 Units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 168 (n=213, 70, 283) | -0.57 Units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 180 (n=180, 57, 237) | -0.63 Units on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 204 (n=109, 30, 139) | -0.67 Units on a scale | Standard Error 0.09 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 192 (n=138, 42, 180) | -0.61 Units on a scale | Standard Error 0.09 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 216 (n=76, 13, 89) | -0.42 Units on a scale | Standard Error 0.09 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 228 (n=68, 5, 73) | -0.25 Units on a scale | Standard Error 0.1 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 120 (n=242, 80, 322) | -0.63 Units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 240 (n=65, 5, 70) | -0.33 Units on a scale | Standard Error 0.14 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 264 (n=59, 5, 64) | -0.23 Units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 276 (n=22, 1, 23) | -0.63 Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 144 (n=224, 76, 300) | -0.59 Units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 252 (n=65, 5, 70) | -0.25 Units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 (n=370, 105, 475) | -0.51 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 24 (n=357, 104, 461) | -0.55 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 (n=372, 105, 477) | -0.45 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 36 (n=339, 102, 441) | -0.54 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 48 (n=331, 102, 433) | -0.62 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 132 (n=232, 79, 311) | -0.64 Units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 (n=371, 105, 476) | -0.49 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 72 (n=315, 99, 414) | -0.60 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 84 (n=309, 92, 401) | -0.61 Units on a scale | Standard Error 0.05 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 96 (n=281, 87, 368) | -0.61 Units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 108 (n=259, 84, 343) | -0.64 Units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 (n= 378, 105, 483) | -0.44 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 84 (n=309, 92, 401) | -0.69 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 132 (n=232, 79, 311) | -0.68 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 144 (n=224, 76, 300) | -0.65 Units on a scale | Standard Error 0.04 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 264 (n=59, 5, 64) | -0.62 Units on a scale | Standard Error 0.07 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 (n= 378, 105, 483) | -0.53 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 156 (n=219, 72, 291) | -0.66 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 (n=372, 105, 477) | -0.57 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 168 (n=213, 70, 283) | -0.65 Units on a scale | Standard Error 0.04 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 252 (n=65, 5, 70) | -0.65 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 60 (n=323, 102, 425) | -0.67 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 (n=370, 105, 475) | -0.63 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 192 (n=138, 42, 180) | -0.67 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 204 (n=109, 30, 139) | -0.67 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 216 (n=76, 13, 89) | -0.59 Units on a scale | Standard Error 0.05 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 108 (n=259, 84, 343) | -0.69 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 24 (n=357, 104, 461) | -0.65 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 228 (n=68, 5, 73) | -0.59 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 96 (n=281, 87, 368) | -0.69 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 72 (n=315, 99, 414) | -0.69 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 120 (n=242, 80, 322) | -0.68 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 36 (n=339, 102, 441) | -0.66 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 240 (n=65, 5, 70) | -0.64 Units on a scale | Standard Error 0.06 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 180 (n=180, 57, 237) | -0.68 Units on a scale | Standard Error 0.04 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 276 (n=22, 1, 23) | -0.82 Units on a scale | Standard Error 0.11 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 (n=371, 105, 476) | -0.62 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 48 (n=331, 102, 433) | -0.68 Units on a scale | Standard Error 0.03 |
| Total | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 288 (n=3, 0, 3) | -0.96 Units on a scale | Standard Error 0.37 |
Secondary
Change From Baseline in 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 4 (n=372, 105, 477) | -37.32 Units on a scale | Standard Error 1.38 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 8 (n=371, 105, 476) | -39.54 Units on a scale | Standard Error 1.34 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 216 (n=76, 13, 89) | -41.61 Units on a scale | Standard Error 2.9 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 228 (n=68, 5, 73) | -37.19 Units on a scale | Standard Error 2.96 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 60 (n=323, 102, 425) | -42.37 Units on a scale | Standard Error 1.44 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 240 (n=65, 5, 70) | -36.72 Units on a scale | Standard Error 3.08 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 252 (n=65, 5, 70) | -38.54 Units on a scale | Standard Error 3.19 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 204 (n=109, 30, 139) | -41.11 Units on a scale | Standard Error 2.59 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 264 (n=59, 5, 64) | -36.80 Units on a scale | Standard Error 3.72 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 72 (n=315, 99, 414) | -41.84 Units on a scale | Standard Error 1.51 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 276 (n=21, 1, 22) | -40.19 Units on a scale | Standard Error 5 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 288 (n=3, 0, 3) | -34.67 Units on a scale | Standard Error 9.82 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 12 (n=370, 105, 475) | -39.34 Units on a scale | Standard Error 1.36 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 84 (n=309, 92, 401) | -42.49 Units on a scale | Standard Error 1.53 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 2 (n= 378, 105, 483) | -34.23 Units on a scale | Standard Error 1.4 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 96 (n=281, 87, 368) | -42.21 Units on a scale | Standard Error 1.63 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 108 (n=259, 84, 343) | -42.61 Units on a scale | Standard Error 1.68 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 120 (n=242, 80, 322) | -42.44 Units on a scale | Standard Error 1.74 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 24 (n=357, 104, 461) | -40.70 Units on a scale | Standard Error 1.42 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 132 (n=232, 79, 311) | -42.52 Units on a scale | Standard Error 1.78 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 144 (n=224, 76, 300) | -42.05 Units on a scale | Standard Error 1.81 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 36 (n=339, 102, 441) | -41.70 Units on a scale | Standard Error 1.45 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 156 (n=219, 72, 291) | -43.77 Units on a scale | Standard Error 1.75 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 168 (n=213, 70, 283) | -43.87 Units on a scale | Standard Error 1.73 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 180 (n=180, 57, 237) | -43.85 Units on a scale | Standard Error 1.92 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 48 (n=331, 102, 433) | -41.98 Units on a scale | Standard Error 1.41 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 192 (n=138, 42, 180) | -42.64 Units on a scale | Standard Error 2.22 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 84 (n=309, 92, 401) | -37.65 Units on a scale | Standard Error 2.55 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 180 (n=180, 57, 237) | -40.21 Units on a scale | Standard Error 3.51 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 96 (n=281, 87, 368) | -38.21 Units on a scale | Standard Error 2.87 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 216 (n=76, 13, 89) | -30.38 Units on a scale | Standard Error 9.3 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 8 (n=371, 105, 476) | -30.69 Units on a scale | Standard Error 2.32 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 12 (n=370, 105, 475) | -29.03 Units on a scale | Standard Error 2.25 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 156 (n=219, 72, 291) | -36.39 Units on a scale | Standard Error 2.89 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 4 (n=372, 105, 477) | -27.70 Units on a scale | Standard Error 2.61 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 240 (n=65, 5, 70) | -21.20 Units on a scale | Standard Error 7.85 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 60 (n=323, 102, 425) | -36.65 Units on a scale | Standard Error 2.36 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 36 (n=339, 102, 441) | -32.71 Units on a scale | Standard Error 2.56 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 252 (n=65, 5, 70) | -21.20 Units on a scale | Standard Error 10.56 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 120 (n=242, 80, 322) | -37.45 Units on a scale | Standard Error 2.92 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 192 (n=138, 42, 180) | -36.67 Units on a scale | Standard Error 3.93 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 264 (n=59, 5, 64) | -16.60 Units on a scale | Standard Error 11.91 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 168 (n=213, 70, 283) | -37.96 Units on a scale | Standard Error 3.24 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 132 (n=232, 79, 311) | -37.86 Units on a scale | Standard Error 3.04 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 276 (n=21, 1, 22) | -44.00 Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 72 (n=315, 99, 414) | -37.41 Units on a scale | Standard Error 2.28 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 24 (n=357, 104, 461) | -33.60 Units on a scale | Standard Error 2.5 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 2 (n= 378, 105, 483) | -27.98 Units on a scale | Standard Error 2.39 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 108 (n=259, 84, 343) | -37.99 Units on a scale | Standard Error 2.87 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 204 (n=109, 30, 139) | -38.70 Units on a scale | Standard Error 5.25 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 228 (n=68, 5, 73) | -28.40 Units on a scale | Standard Error 12.48 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 144 (n=224, 76, 300) | -37.07 Units on a scale | Standard Error 3.09 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Week 48 (n=331, 102, 433) | -34.39 Units on a scale | Standard Error 2.52 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 24 (n=357, 104, 461) | -39.10 Units on a scale | Standard Error 1.24 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 4 (n=372, 105, 477) | -35.20 Units on a scale | Standard Error 1.23 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 8 (n=371, 105, 476) | -37.59 Units on a scale | Standard Error 1.17 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 12 (n=370, 105, 475) | -37.06 Units on a scale | Standard Error 1.18 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 36 (n=339, 102, 441) | -39.62 Units on a scale | Standard Error 1.27 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 48 (n=331, 102, 433) | -40.19 Units on a scale | Standard Error 1.24 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 84 (n=309, 92, 401) | -41.38 Units on a scale | Standard Error 1.32 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 60 (n=323, 102, 425) | -41.00 Units on a scale | Standard Error 1.24 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 72 (n=315, 99, 414) | -40.79 Units on a scale | Standard Error 1.28 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 96 (n=281, 87, 368) | -41.27 Units on a scale | Standard Error 1.42 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 108 (n=259, 84, 343) | -41.48 Units on a scale | Standard Error 1.45 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 120 (n=242, 80, 322) | -41.20 Units on a scale | Standard Error 1.5 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 132 (n=232, 79, 311) | -41.33 Units on a scale | Standard Error 1.54 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 144 (n=224, 76, 300) | -40.79 Units on a scale | Standard Error 1.56 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 156 (n=219, 72, 291) | -41.94 Units on a scale | Standard Error 1.51 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 168 (n=213, 70, 283) | -42.41 Units on a scale | Standard Error 1.54 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 180 (n=180, 57, 237) | -42.97 Units on a scale | Standard Error 1.68 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 192 (n=138, 42, 180) | -41.24 Units on a scale | Standard Error 1.94 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 204 (n=109, 30, 139) | -40.59 Units on a scale | Standard Error 2.32 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 216 (n=76, 13, 89) | -39.97 Units on a scale | Standard Error 2.84 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 228 (n=68, 5, 73) | -36.59 Units on a scale | Standard Error 2.87 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 240 (n=65, 5, 70) | -35.61 Units on a scale | Standard Error 2.94 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 252 (n=65, 5, 70) | -37.30 Units on a scale | Standard Error 3.08 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 264 (n=59, 5, 64) | -35.22 Units on a scale | Standard Error 3.6 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 276 (n=21, 1, 22) | -40.36 Units on a scale | Standard Error 4.77 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 288 (n=3, 0, 3) | -34.67 Units on a scale | Standard Error 9.82 |
| Total | Change From Baseline in Patient Assessment of Arthritis Pain | Week 2 (n= 378, 105, 483) | -32.87 Units on a scale | Standard Error 1.22 |
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 132 (n=232, 79, 311) | -42.87 Units on a scale | Standard Error 1.73 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 36 (n=339, 102, 441) | -41.70 Units on a scale | Standard Error 1.42 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 240 (n=65, 5, 70) | -38.91 Units on a scale | Standard Error 2.98 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 156 (n=219, 72, 291) | -42.72 Units on a scale | Standard Error 1.71 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 2 (n= 378, 105, 483) | -34.52 Units on a scale | Standard Error 1.38 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 228 (n=68, 5, 73) | -37.09 Units on a scale | Standard Error 2.96 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 168 (n=213, 70, 283) | -43.00 Units on a scale | Standard Error 1.72 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 60 (n=323, 102, 425) | -41.79 Units on a scale | Standard Error 1.44 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 216 (n=76, 13, 89) | -42.04 Units on a scale | Standard Error 2.87 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 180 (n=180, 57, 237) | -43.22 Units on a scale | Standard Error 1.91 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 276 (n=21, 1, 22) | -35.62 Units on a scale | Standard Error 6.09 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 204 (n=109, 30, 139) | -42.44 Units on a scale | Standard Error 2.36 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 192 (n=138, 42, 180) | -42.05 Units on a scale | Standard Error 2.1 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 48 (n=331, 102, 433) | -41.03 Units on a scale | Standard Error 1.46 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 72 (n=315, 99, 414) | -41.30 Units on a scale | Standard Error 1.53 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 144 (n=224, 76, 300) | -42.48 Units on a scale | Standard Error 1.77 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 24 (n=357, 104, 461) | -40.67 Units on a scale | Standard Error 1.39 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 84 (n=309, 92, 401) | -42.29 Units on a scale | Standard Error 1.53 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 12 (n=370, 105, 475) | -39.31 Units on a scale | Standard Error 1.38 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 8 (n=371, 105, 476) | -39.61 Units on a scale | Standard Error 1.35 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 288 (n=3, 0, 3) | -41.67 Units on a scale | Standard Error 7.31 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 108 (n=259, 84, 343) | -42.47 Units on a scale | Standard Error 1.67 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 4 (n=372, 105, 477) | -37.81 Units on a scale | Standard Error 1.36 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 264 (n=59, 5, 64) | -37.32 Units on a scale | Standard Error 3.69 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 120 (n=242, 80, 322) | -42.97 Units on a scale | Standard Error 1.71 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 96 (n=281, 87, 368) | -41.90 Units on a scale | Standard Error 1.62 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 252 (n=65, 5, 70) | -40.37 Units on a scale | Standard Error 2.92 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 36 (n=339, 102, 441) | -29.95 Units on a scale | Standard Error 2.63 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 2 (n= 378, 105, 483) | -25.38 Units on a scale | Standard Error 2.43 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 8 (n=371, 105, 476) | -28.86 Units on a scale | Standard Error 2.31 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 12 (n=370, 105, 475) | -27.33 Units on a scale | Standard Error 2.23 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 60 (n=323, 102, 425) | -34.33 Units on a scale | Standard Error 2.42 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 72 (n=315, 99, 414) | -35.38 Units on a scale | Standard Error 2.31 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 84 (n=309, 92, 401) | -35.12 Units on a scale | Standard Error 2.63 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 108 (n=259, 84, 343) | -34.95 Units on a scale | Standard Error 2.98 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 120 (n=242, 80, 322) | -35.00 Units on a scale | Standard Error 3.05 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 132 (n=232, 79, 311) | -35.05 Units on a scale | Standard Error 3.13 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 156 (n=219, 72, 291) | -32.64 Units on a scale | Standard Error 3.13 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 168 (n=213, 70, 283) | -33.61 Units on a scale | Standard Error 3.22 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 180 (n=180, 57, 237) | -36.14 Units on a scale | Standard Error 3.72 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 192 (n=138, 42, 180) | -34.40 Units on a scale | Standard Error 3.95 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 204 (n=109, 30, 139) | -35.73 Units on a scale | Standard Error 5.31 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 216 (n=76, 13, 89) | -23.92 Units on a scale | Standard Error 9.22 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 228 (n=68, 5, 73) | -17.60 Units on a scale | Standard Error 10.66 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 240 (n=65, 5, 70) | -18.20 Units on a scale | Standard Error 8.36 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 252 (n=65, 5, 70) | -7.60 Units on a scale | Standard Error 9.17 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 264 (n=59, 5, 64) | -16.20 Units on a scale | Standard Error 9.01 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 4 (n=372, 105, 477) | -25.34 Units on a scale | Standard Error 2.61 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 24 (n=357, 104, 461) | -30.75 Units on a scale | Standard Error 2.53 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 48 (n=331, 102, 433) | -32.48 Units on a scale | Standard Error 2.56 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 96 (n=281, 87, 368) | -34.98 Units on a scale | Standard Error 2.88 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 144 (n=224, 76, 300) | -33.78 Units on a scale | Standard Error 3.22 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Week 276 (n=21, 1, 22) | -10.00 Units on a scale | — |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 2 (n= 378, 105, 483) | -32.54 Units on a scale | Standard Error 1.21 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 252 (n=65, 5, 70) | -38.03 Units on a scale | Standard Error 2.95 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 108 (n=259, 84, 343) | -40.63 Units on a scale | Standard Error 1.46 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 132 (n=232, 79, 311) | -40.88 Units on a scale | Standard Error 1.52 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 96 (n=281, 87, 368) | -40.27 Units on a scale | Standard Error 1.42 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 8 (n=371, 105, 476) | -37.24 Units on a scale | Standard Error 1.19 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 288 (n=3, 0, 3) | -41.67 Units on a scale | Standard Error 7.31 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 276 (n=21, 1, 22) | -34.45 Units on a scale | Standard Error 5.92 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 4 (n=372, 105, 477) | -35.06 Units on a scale | Standard Error 1.23 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 84 (n=309, 92, 401) | -40.65 Units on a scale | Standard Error 1.33 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 72 (n=315, 99, 414) | -39.88 Units on a scale | Standard Error 1.29 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 240 (n=65, 5, 70) | -37.43 Units on a scale | Standard Error 2.89 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 24 (n=357, 104, 461) | -38.43 Units on a scale | Standard Error 1.24 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 36 (n=339, 102, 441) | -38.98 Units on a scale | Standard Error 1.27 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 192 (n=138, 42, 180) | -40.27 Units on a scale | Standard Error 1.86 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 180 (n=180, 57, 237) | -41.52 Units on a scale | Standard Error 1.71 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 60 (n=323, 102, 425) | -40.00 Units on a scale | Standard Error 1.25 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 204 (n=109, 30, 139) | -40.99 Units on a scale | Standard Error 2.18 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 168 (n=213, 70, 283) | -40.67 Units on a scale | Standard Error 1.53 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 264 (n=59, 5, 64) | -35.67 Units on a scale | Standard Error 3.54 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 216 (n=76, 13, 89) | -39.39 Units on a scale | Standard Error 2.86 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 156 (n=219, 72, 291) | -40.22 Units on a scale | Standard Error 1.52 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 48 (n=331, 102, 433) | -39.02 Units on a scale | Standard Error 1.28 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 228 (n=68, 5, 73) | -35.75 Units on a scale | Standard Error 2.89 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 144 (n=224, 76, 300) | -40.27 Units on a scale | Standard Error 1.57 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 12 (n=370, 105, 475) | -36.67 Units on a scale | Standard Error 1.2 |
| Total | Change From Baseline in Patient Global Assessment of Arthritis | Week 120 (n=242, 80, 322) | -40.99 Units on a scale | Standard Error 1.5 |
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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 204 (n=109, 30, 139) | -51.10 Units on a scale | Standard Error 1.73 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 96 (n=281, 87, 368) | -49.99 Units on a scale | Standard Error 1.28 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 2 (n= 378, 105, 483) | -42.80 Units on a scale | Standard Error 1.13 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 192 (n=138, 42, 180) | -51.41 Units on a scale | Standard Error 1.72 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 108 (n=259, 83, 342) | -49.62 Units on a scale | Standard Error 1.33 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 276 (n=21, 1, 22) | -53.05 Units on a scale | Standard Error 3.92 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 180 (n=180, 57, 237) | -52.20 Units on a scale | Standard Error 1.51 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 120 (n=242, 80, 322) | -49.42 Units on a scale | Standard Error 1.47 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 24 (n=357, 104, 461) | -48.29 Units on a scale | Standard Error 1.07 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 168 (n=213, 70, 283) | -51.52 Units on a scale | Standard Error 1.45 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 132 (n=231, 78, 309) | -49.99 Units on a scale | Standard Error 1.41 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 36 (n=339, 102, 441) | -49.28 Units on a scale | Standard Error 1.09 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 156 (n=219, 72, 291) | -50.68 Units on a scale | Standard Error 1.39 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 144 (n=224, 76, 300) | -50.80 Units on a scale | Standard Error 1.46 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 264 (n=58, 5, 63) | -52.62 Units on a scale | Standard Error 2.36 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 252 (n=65, 5, 70) | -51.78 Units on a scale | Standard Error 2.17 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 48 (n=331, 102, 433) | -49.96 Units on a scale | Standard Error 1.13 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 8 (n=371, 105, 476) | -47.34 Units on a scale | Standard Error 1.06 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 240 (n=65, 5, 70) | -49.94 Units on a scale | Standard Error 2.25 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 60 (n=323, 102, 425) | -49.89 Units on a scale | Standard Error 1.14 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 4 (n=372, 105, 477) | -46.06 Units on a scale | Standard Error 1.08 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 228 (n=67, 5, 72) | -49.57 Units on a scale | Standard Error 2.37 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 72 (n=315, 99, 414) | -50.03 Units on a scale | Standard Error 1.14 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 288 (n=3, 0, 3) | -37.67 Units on a scale | Standard Error 1.33 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 216 (n=76, 13, 89) | -50.91 Units on a scale | Standard Error 2.01 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 84 (n=309, 92, 401) | -50.61 Units on a scale | Standard Error 1.16 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 12 (n=370, 105, 475) | -47.78 Units on a scale | Standard Error 1.09 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 36 (n=339, 102, 441) | -41.92 Units on a scale | Standard Error 2.01 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 2 (n= 378, 105, 483) | -33.49 Units on a scale | Standard Error 2.01 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 4 (n=372, 105, 477) | -34.91 Units on a scale | Standard Error 2.2 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 8 (n=371, 105, 476) | -37.15 Units on a scale | Standard Error 2 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 12 (n=370, 105, 475) | -36.56 Units on a scale | Standard Error 2.33 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 24 (n=357, 104, 461) | -41.26 Units on a scale | Standard Error 2.01 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 48 (n=331, 102, 433) | -45.28 Units on a scale | Standard Error 2.08 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 60 (n=323, 102, 425) | -47.01 Units on a scale | Standard Error 2.05 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 72 (n=315, 99, 414) | -45.70 Units on a scale | Standard Error 1.95 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 84 (n=309, 92, 401) | -46.89 Units on a scale | Standard Error 2.17 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 96 (n=281, 87, 368) | -48.16 Units on a scale | Standard Error 2.23 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 108 (n=259, 83, 342) | -47.99 Units on a scale | Standard Error 2.56 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 120 (n=242, 80, 322) | -47.76 Units on a scale | Standard Error 2.39 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 132 (n=231, 78, 309) | -50.19 Units on a scale | Standard Error 2.33 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 144 (n=224, 76, 300) | -49.55 Units on a scale | Standard Error 2.44 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 156 (n=219, 72, 291) | -49.78 Units on a scale | Standard Error 2.58 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 168 (n=213, 70, 283) | -46.33 Units on a scale | Standard Error 2.6 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 180 (n=180, 57, 237) | -50.33 Units on a scale | Standard Error 2.84 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 192 (n=138, 42, 180) | -50.43 Units on a scale | Standard Error 2.98 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 204 (n=109, 30, 139) | -50.97 Units on a scale | Standard Error 4.12 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 216 (n=76, 13, 89) | -42.77 Units on a scale | Standard Error 6.37 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 228 (n=67, 5, 72) | -33.60 Units on a scale | Standard Error 8.88 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 240 (n=65, 5, 70) | -34.40 Units on a scale | Standard Error 10.3 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 252 (n=65, 5, 70) | -31.60 Units on a scale | Standard Error 7.92 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 264 (n=58, 5, 63) | -33.80 Units on a scale | Standard Error 9.49 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 276 (n=21, 1, 22) | -7.00 Units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Week 288 (n=3, 0, 3) | NA Units on a scale | — |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 192 (n=138, 42, 180) | -51.18 Units on a scale | Standard Error 1.49 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 84 (n=309, 92, 401) | -49.75 Units on a scale | Standard Error 1.02 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 12 (n=370, 105, 475) | -45.30 Units on a scale | Standard Error 1 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 204 (n=109, 30, 139) | -51.07 Units on a scale | Standard Error 1.61 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 72 (n=315, 99, 414) | -48.99 Units on a scale | Standard Error 0.99 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 4 (n=372, 105, 477) | -43.60 Units on a scale | Standard Error 0.99 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 216 (n=76, 13, 89) | -49.72 Units on a scale | Standard Error 1.96 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 60 (n=323, 102, 425) | -49.20 Units on a scale | Standard Error 1 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 276 (n=21, 1, 22) | -50.95 Units on a scale | Standard Error 4.29 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 228 (n=67, 5, 72) | -48.46 Units on a scale | Standard Error 2.33 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 48 (n=331, 102, 433) | -48.86 Units on a scale | Standard Error 1 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 8 (n=371, 105, 476) | -45.09 Units on a scale | Standard Error 0.95 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 240 (n=65, 5, 70) | -48.83 Units on a scale | Standard Error 2.25 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 36 (n=339, 102, 441) | -47.58 Units on a scale | Standard Error 0.97 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 2 (n= 378, 105, 483) | -40.78 Units on a scale | Standard Error 1 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 144 (n=224, 76, 300) | -50.49 Units on a scale | Standard Error 1.25 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 132 (n=231, 78, 309) | -50.04 Units on a scale | Standard Error 1.2 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 252 (n=65, 5, 70) | -50.34 Units on a scale | Standard Error 2.17 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 156 (n=219, 72, 291) | -50.46 Units on a scale | Standard Error 1.23 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 120 (n=242, 80, 322) | -49.01 Units on a scale | Standard Error 1.26 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 24 (n=357, 104, 461) | -46.70 Units on a scale | Standard Error 0.95 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 168 (n=213, 70, 283) | -50.23 Units on a scale | Standard Error 1.27 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 108 (n=259, 83, 342) | -49.22 Units on a scale | Standard Error 1.18 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 288 (n=3, 0, 3) | -37.67 Units on a scale | Standard Error 1.33 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 180 (n=180, 57, 237) | -51.75 Units on a scale | Standard Error 1.33 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 96 (n=281, 87, 368) | -49.55 Units on a scale | Standard Error 1.11 |
| Total | Change From Baseline in Physician Global Assessment of Arthritis | Week 264 (n=58, 5, 63) | -51.13 Units on a scale | Standard Error 2.36 |
Secondary
Change From Baseline in Swollen Joint Counts
Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 252 (n=65, 5, 70) | -13.20 Swollen joints | Standard Error 1.15 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 180 (n=180, 57, 237) | -12.43 Swollen joints | Standard Error 0.7 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 84 (n=309, 92, 401) | -12.08 Swollen joints | Standard Error 0.47 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 12 (n=370, 105, 475) | -11.18 Swollen joints | Standard Error 0.4 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 168 (n=213, 70, 283) | -12.17 Swollen joints | Standard Error 0.62 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 96 (n=281, 87, 368) | -11.97 Swollen joints | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 4 (n=373, 105, 478) | -10.12 Swollen joints | Standard Error 0.42 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 156 (n=219, 72, 291) | -12.07 Swollen joints | Standard Error 0.61 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 108 (n=259, 83, 342) | -11.94 Swollen joints | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 144 (n=224, 76, 300) | -11.90 Swollen joints | Standard Error 0.61 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 120 (n=242, 80, 322) | -12.09 Swollen joints | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 240 (n=65, 5, 70) | -13.09 Swollen joints | Standard Error 1.12 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 132 (n=232, 79, 311) | -11.69 Swollen joints | Standard Error 0.64 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 24 (n=357, 104, 461) | -11.33 Swollen joints | Standard Error 0.4 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 2 (n=378, 105, 483) | -9.67 Swollen joints | Standard Error 0.38 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 228 (n=68, 5, 73) | -11.74 Swollen joints | Standard Error 1.47 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 36 (n=339, 102, 441) | -11.62 Swollen joints | Standard Error 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 276 (n=22, 1, 23) | -15.32 Swollen joints | Standard Error 2.53 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 216 (n=76, 13, 89) | -12.34 Swollen joints | Standard Error 0.99 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 48 (n=331, 102, 433) | -11.76 Swollen joints | Standard Error 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 8 (n=371, 105, 476) | -10.90 Swollen joints | Standard Error 0.39 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 204 (n=109, 30, 139) | -12.35 Swollen joints | Standard Error 0.82 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 264 (n=59, 5, 64) | -13.58 Swollen joints | Standard Error 1.24 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 60 (n=323, 102, 425) | -11.83 Swollen joints | Standard Error 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 288 (n=3, 0, 3) | -8.33 Swollen joints | Standard Error 0.88 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 192 (n=138, 42, 180) | -12.36 Swollen joints | Standard Error 0.79 |
| CP-690,550 5 mg BID | Change From Baseline in Swollen Joint Counts | Week 72 (n=315, 99, 414) | -12.00 Swollen joints | Standard Error 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 288 (n=3, 0, 3) | NA Swollen joints | — |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 4 (n=373, 105, 478) | -8.54 Swollen joints | Standard Error 0.75 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 8 (n=371, 105, 476) | -9.31 Swollen joints | Standard Error 0.73 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 12 (n=370, 105, 475) | -9.21 Swollen joints | Standard Error 0.67 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 24 (n=357, 104, 461) | -10.46 Swollen joints | Standard Error 0.72 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 36 (n=339, 102, 441) | -10.75 Swollen joints | Standard Error 0.73 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 48 (n=331, 102, 433) | -11.11 Swollen joints | Standard Error 0.74 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 108 (n=259, 83, 342) | -11.60 Swollen joints | Standard Error 0.91 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 60 (n=323, 102, 425) | -10.97 Swollen joints | Standard Error 0.76 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 72 (n=315, 99, 414) | -11.38 Swollen joints | Standard Error 0.8 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 84 (n=309, 92, 401) | -11.72 Swollen joints | Standard Error 0.88 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 96 (n=281, 87, 368) | -11.54 Swollen joints | Standard Error 0.84 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 120 (n=242, 80, 322) | -11.24 Swollen joints | Standard Error 0.87 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 132 (n=232, 79, 311) | -11.15 Swollen joints | Standard Error 1.16 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 144 (n=224, 76, 300) | -11.74 Swollen joints | Standard Error 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 156 (n=219, 72, 291) | -11.86 Swollen joints | Standard Error 1.04 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 168 (n=213, 70, 283) | -11.67 Swollen joints | Standard Error 1.05 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 180 (n=180, 57, 237) | -12.26 Swollen joints | Standard Error 1.24 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 192 (n=138, 42, 180) | -12.48 Swollen joints | Standard Error 1.47 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 204 (n=109, 30, 139) | 12.50 Swollen joints | Standard Error 1.89 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 216 (n=76, 13, 89) | -9.00 Swollen joints | Standard Error 2.35 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 228 (n=68, 5, 73) | -11.00 Swollen joints | Standard Error 5.09 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 240 (n=65, 5, 70) | -11.40 Swollen joints | Standard Error 5.48 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 252 (n=65, 5, 70) | -10.60 Swollen joints | Standard Error 4.7 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 264 (n=59, 5, 64) | -10.00 Swollen joints | Standard Error 4.11 |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 276 (n=22, 1, 23) | -6.00 Swollen joints | — |
| CP-690,550 10 mg BID | Change From Baseline in Swollen Joint Counts | Week 2 (n=378, 105, 483) | -8.69 Swollen joints | Standard Error 0.74 |
| Total | Change From Baseline in Swollen Joint Counts | Week 180 (n=180, 57, 237) | -12.39 Swollen joints | Standard Error 0.61 |
| Total | Change From Baseline in Swollen Joint Counts | Week 60 (n=323, 102, 425) | -11.62 Swollen joints | Standard Error 0.38 |
| Total | Change From Baseline in Swollen Joint Counts | Week 252 (n=65, 5, 70) | -13.01 Swollen joints | Standard Error 1.11 |
| Total | Change From Baseline in Swollen Joint Counts | Week 192 (n=138, 42, 180) | -12.38 Swollen joints | Standard Error 0.69 |
| Total | Change From Baseline in Swollen Joint Counts | Week 48 (n=331, 102, 433) | -11.61 Swollen joints | Standard Error 0.38 |
| Total | Change From Baseline in Swollen Joint Counts | Week 288 (n=3, 0, 3) | -8.33 Swollen joints | Standard Error 0.88 |
| Total | Change From Baseline in Swollen Joint Counts | Week 204 (n=109, 30, 139) | 12.38 Swollen joints | Standard Error 0.76 |
| Total | Change From Baseline in Swollen Joint Counts | Week 36 (n=339, 102, 441) | -11.41 Swollen joints | Standard Error 0.37 |
| Total | Change From Baseline in Swollen Joint Counts | Week 276 (n=22, 1, 23) | -14.91 Swollen joints | Standard Error 2.46 |
| Total | Change From Baseline in Swollen Joint Counts | Week 216 (n=76, 13, 89) | -11.85 Swollen joints | Standard Error 0.91 |
| Total | Change From Baseline in Swollen Joint Counts | Week 24 (n=357, 104, 461) | -11.13 Swollen joints | Standard Error 0.35 |
| Total | Change From Baseline in Swollen Joint Counts | Week 264 (n=59, 5, 64) | -13.30 Swollen joints | Standard Error 1.19 |
| Total | Change From Baseline in Swollen Joint Counts | Week 228 (n=68, 5, 73) | -11.68 Swollen joints | Standard Error 1.41 |
| Total | Change From Baseline in Swollen Joint Counts | Week 120 (n=242, 80, 322) | -11.88 Swollen joints | Standard Error 0.47 |
| Total | Change From Baseline in Swollen Joint Counts | Week 12 (n=370, 105, 475) | -10.74 Swollen joints | Standard Error 0.35 |
| Total | Change From Baseline in Swollen Joint Counts | Week 132 (n=232, 79, 311) | -11.55 Swollen joints | Standard Error 0.56 |
| Total | Change From Baseline in Swollen Joint Counts | Week 108 (n=259, 83, 342) | -11.86 Swollen joints | Standard Error 0.45 |
| Total | Change From Baseline in Swollen Joint Counts | Week 4 (n=373, 105, 478) | -9.78 Swollen joints | Standard Error 0.37 |
| Total | Change From Baseline in Swollen Joint Counts | Week 144 (n=224, 76, 300) | -11.86 Swollen joints | Standard Error 0.51 |
| Total | Change From Baseline in Swollen Joint Counts | Week 96 (n=281, 87, 368) | -11.87 Swollen joints | Standard Error 0.43 |
| Total | Change From Baseline in Swollen Joint Counts | Week 240 (n=65, 5, 70) | -12.97 Swollen joints | Standard Error 1.1 |
| Total | Change From Baseline in Swollen Joint Counts | Week 156 (n=219, 72, 291) | -12.02 Swollen joints | Standard Error 0.52 |
| Total | Change From Baseline in Swollen Joint Counts | Week 84 (n=309, 92, 401) | -12.00 Swollen joints | Standard Error 0.41 |
| Total | Change From Baseline in Swollen Joint Counts | Week 8 (n=371, 105, 476) | -10.55 Swollen joints | Standard Error 0.35 |
| Total | Change From Baseline in Swollen Joint Counts | Week 168 (n=213, 70, 283) | -12.05 Swollen joints | Standard Error 0.54 |
| Total | Change From Baseline in Swollen Joint Counts | Week 72 (n=315, 99, 414) | -11.85 Swollen joints | Standard Error 0.4 |
| Total | Change From Baseline in Swollen Joint Counts | Week 2 (n=378, 105, 483) | -9.46 Swollen joints | Standard Error 0.34 |
Secondary
Change From Baseline in Tender/Painful Joint Counts
This was carried out on 68 joints. Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 96 (n=281, 87, 368) | -14.44 Tender/painful joints | Standard Error 0.6 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 12 (n=370, 105, 475) | -13.41 Tender/painful joints | Standard Error 0.47 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 192 (n=138, 42, 180) | -15.01 Tender/painful joints | Standard Error 0.87 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 108 (n=259, 83, 342) | -14.46 Tender/painful joints | Standard Error 0.61 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 24 (n=357, 104, 461) | -14.02 Tender/painful joints | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 180 (n=180, 57, 237) | -14.78 Tender/painful joints | Standard Error 0.79 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 120 (n=242, 80, 322) | -14.67 Tender/painful joints | Standard Error 0.65 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 216 (n=76, 13, 89) | -14.42 Tender/painful joints | Standard Error 1.04 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 168 (n=213, 70, 283) | -14.41 Tender/painful joints | Standard Error 0.73 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 132 (n=232, 79, 311) | -14.01 Tender/painful joints | Standard Error 0.73 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 276 (n=22, 1, 23) | -17.55 Tender/painful joints | Standard Error 2.55 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 156 (n=219, 72, 291) | -14.24 Tender/painful joints | Standard Error 0.7 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 144 (n=224, 76, 300) | -14.45 Tender/painful joints | Standard Error 0.68 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 36 (n=339, 102, 441) | -14.32 Tender/painful joints | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 4 (n=373, 105, 478) | -12.13 Tender/painful joints | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 264 (n=59, 5, 64) | -15.54 Tender/painful joints | Standard Error 1.27 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 48 (n=331, 102, 433) | -14.23 Tender/painful joints | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 60 (n=323, 102, 425) | -14.23 Tender/painful joints | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 252 (n=65, 5, 70) | -15.34 Tender/painful joints | Standard Error 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 8 (n=371, 105, 476) | -13.06 Tender/painful joints | Standard Error 0.47 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 240 (n=65, 5, 70) | -15.11 Tender/painful joints | Standard Error 1.15 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 72 (n=315, 99, 414) | -14.45 Tender/painful joints | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 2 (n=378, 105, 483) | -11.88 Tender/painful joints | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 228 (n=68, 5, 73) | -13.78 Tender/painful joints | Standard Error 1.56 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 84 (n=309, 92, 401) | -14.39 Tender/painful joints | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 288 (n=3, 0, 3) | -8.67 Tender/painful joints | Standard Error 1.2 |
| CP-690,550 5 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 204 (n=109, 30, 139) | -14.79 Tender/painful joints | Standard Error 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 216 (n=76, 13, 89) | -11.38 Tender/painful joints | Standard Error 2.64 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 2 (n=378, 105, 483) | -10.17 Tender/painful joints | Standard Error 0.95 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 8 (n=371, 105, 476) | -10.75 Tender/painful joints | Standard Error 0.96 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 24 (n=357, 104, 461) | -12.62 Tender/painful joints | Standard Error 0.89 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 36 (n=339, 102, 441) | -13.05 Tender/painful joints | Standard Error 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 48 (n=331, 102, 433) | -13.43 Tender/painful joints | Standard Error 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 60 (n=323, 102, 425) | -13.67 Tender/painful joints | Standard Error 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 72 (n=315, 99, 414) | -14.00 Tender/painful joints | Standard Error 0.96 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 84 (n=309, 92, 401) | -14.04 Tender/painful joints | Standard Error 1.11 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 96 (n=281, 87, 368) | -13.92 Tender/painful joints | Standard Error 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 108 (n=259, 83, 342) | -13.66 Tender/painful joints | Standard Error 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 120 (n=242, 80, 322) | -13.69 Tender/painful joints | Standard Error 1.07 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 132 (n=232, 79, 311) | -13.30 Tender/painful joints | Standard Error 1.33 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 144 (n=224, 76, 300) | -13.83 Tender/painful joints | Standard Error 1.18 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 156 (n=219, 72, 291) | -14.15 Tender/painful joints | Standard Error 1.2 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 168 (n=213, 70, 283) | -14.06 Tender/painful joints | Standard Error 1.25 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 180 (n=180, 57, 237) | -15.18 Tender/painful joints | Standard Error 1.46 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 192 (n=138, 42, 180) | -14.57 Tender/painful joints | Standard Error 1.42 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 204 (n=109, 30, 139) | -15.67 Tender/painful joints | Standard Error 1.93 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 228 (n=68, 5, 73) | -11.60 Tender/painful joints | Standard Error 5.46 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 240 (n=65, 5, 70) | -10.80 Tender/painful joints | Standard Error 4.92 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 252 (n=65, 5, 70) | -9.60 Tender/painful joints | Standard Error 4.55 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 264 (n=59, 5, 64) | -9.80 Tender/painful joints | Standard Error 3.95 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 276 (n=22, 1, 23) | -4.00 Tender/painful joints | — |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 288 (n=3, 0, 3) | NA Tender/painful joints | — |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 12 (n=370, 105, 475) | -10.74 Tender/painful joints | Standard Error 0.97 |
| CP-690,550 10 mg BID | Change From Baseline in Tender/Painful Joint Counts | Week 4 (n=373, 105, 478) | -10.46 Tender/painful joints | Standard Error 0.9 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 84 (n=309, 92, 401) | -14.31 Tender/painful joints | Standard Error 0.5 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 276 (n=22, 1, 23) | -16.96 Tender/painful joints | Standard Error 2.51 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 204 (n=109, 30, 139) | -14.98 Tender/painful joints | Standard Error 0.84 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 216 (n=76, 13, 89) | -13.98 Tender/painful joints | Standard Error 0.97 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 72 (n=315, 99, 414) | -14.34 Tender/painful joints | Standard Error 0.48 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 8 (n=371, 105, 476) | -12.55 Tender/painful joints | Standard Error 0.43 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 228 (n=68, 5, 73) | -13.63 Tender/painful joints | Standard Error 1.49 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 60 (n=323, 102, 425) | -14.09 Tender/painful joints | Standard Error 0.48 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 4 (n=373, 105, 478) | -11.77 Tender/painful joints | Standard Error 0.45 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 240 (n=65, 5, 70) | -14.80 Tender/painful joints | Standard Error 1.12 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 48 (n=331, 102, 433) | -14.04 Tender/painful joints | Standard Error 0.47 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 288 (n=3, 0, 3) | -8.67 Tender/painful joints | Standard Error 1.2 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 252 (n=65, 5, 70) | -14.93 Tender/painful joints | Standard Error 1.14 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 36 (n=339, 102, 441) | -14.03 Tender/painful joints | Standard Error 0.46 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 144 (n=224, 76, 300) | -14.29 Tender/painful joints | Standard Error 0.59 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 132 (n=232, 79, 311) | -13.83 Tender/painful joints | Standard Error 0.64 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 2 (n=378, 105, 483) | -11.51 Tender/painful joints | Standard Error 0.43 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 156 (n=219, 72, 291) | -14.22 Tender/painful joints | Standard Error 0.61 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 120 (n=242, 80, 322) | -14.42 Tender/painful joints | Standard Error 0.55 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 264 (n=59, 5, 64) | -15.09 Tender/painful joints | Standard Error 1.22 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 168 (n=213, 70, 283) | -14.33 Tender/painful joints | Standard Error 0.63 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 108 (n=259, 83, 342) | -14.26 Tender/painful joints | Standard Error 0.54 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 24 (n=357, 104, 461) | -13.70 Tender/painful joints | Standard Error 0.44 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 180 (n=180, 57, 237) | -14.87 Tender/painful joints | Standard Error 0.7 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 96 (n=281, 87, 368) | -14.32 Tender/painful joints | Standard Error 0.52 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 12 (n=370, 105, 475) | -12.82 Tender/painful joints | Standard Error 0.43 |
| Total | Change From Baseline in Tender/Painful Joint Counts | Week 192 (n=138, 42, 180) | -14.91 Tender/painful joints | Standard Error 0.74 |
Secondary
Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)
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). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement. Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study.
Time frame: First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96
Population: Participants who had completed Study A3921044 among all participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 96 (n=39, 1, 40) | 0.40 Units on a scale | Standard Error 0.21 |
| CP-690,550 5 mg BID | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 48 (n=64, 7, 71) | 0.27 Units on a scale | Standard Error 0.17 |
| CP-690,550 5 mg BID | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 24 (n=69, 7, 76) | 0.17 Units on a scale | Standard Error 0.09 |
| CP-690,550 10 mg BID | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 96 (n=39, 1, 40) | 1.00 Units on a scale | — |
| CP-690,550 10 mg BID | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 24 (n=69, 7, 76) | 0.50 Units on a scale | Standard Error 0.22 |
| CP-690,550 10 mg BID | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 48 (n=64, 7, 71) | 1.75 Units on a scale | Standard Error 1.16 |
| Total | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 96 (n=39, 1, 40) | 0.42 Units on a scale | Standard Error 0.2 |
| Total | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 24 (n=69, 7, 76) | 0.20 Units on a scale | Standard Error 0.08 |
| Total | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | Week 48 (n=64, 7, 71) | 0.41 Units on a scale | Standard Error 0.19 |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 276 (n=22, 1, 23) | 95.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 156 (n=219, 73, 292) | 91.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 84 (n=309, 92, 401) | 93.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 288 (n=3, 0, 3) | 100 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 216 (n=76, 13, 89) | 96.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 72 (n=315, 99, 414) | 92.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 24 (n=357, 104, 461) | 90.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 (n= 378, 105, 483) | 80.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 180 (n=180, 57, 237) | 92.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 (n=373, 105, 478) | 87.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 144 (n=224, 76, 300) | 89.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 48 (n=331, 102, 433) | 93.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 (n=371, 105, 476) | 90.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 228 (n=68, 5, 73) | 91.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 36 (n=339, 102, 441) | 94.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 (n=370, 105, 475) | 91.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 192 (n=138, 42, 180) | 92.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 132 (n=232, 79, 311) | 92.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 240 (n=65, 5, 70) | 93.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 168 (n=213, 70, 283) | 92.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 120 (n=242, 80, 322) | 91.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 252 (n=65, 5, 70) | 92.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 204 (n=109, 30, 139) | 92.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 108 (n=259, 84, 343) | 91.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 264 (n=59, 5, 64) | 89.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 60 (n=323, 102, 425) | 92.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 96 (n=281, 87, 368) | 92.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 108 (n=259, 84, 343) | 86.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 24 (n=357, 104, 461) | 85.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 36 (n=339, 102, 441) | 87.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 96 (n=281, 87, 368) | 92.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 192 (n=138, 42, 180) | 85.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 204 (n=109, 30, 139) | 90.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 216 (n=76, 13, 89) | 84.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 228 (n=68, 5, 73) | 80.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 240 (n=65, 5, 70) | 80.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 252 (n=65, 5, 70) | 80.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 264 (n=59, 5, 64) | 80.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 276 (n=22, 1, 23) | 100 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 288 (n=3, 0, 3) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 (n= 378, 105, 483) | 68.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 (n=373, 105, 478) | 70.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 (n=371, 105, 476) | 72.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 (n=370, 105, 475) | 77.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 48 (n=331, 102, 433) | 88.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 60 (n=323, 102, 425) | 90.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 72 (n=315, 99, 414) | 86.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 84 (n=309, 92, 401) | 87.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 120 (n=242, 80, 322) | 88.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 132 (n=232, 79, 311) | 84.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 144 (n=224, 76, 300) | 86.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 156 (n=219, 73, 292) | 84.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 168 (n=213, 70, 283) | 82.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 180 (n=180, 57, 237) | 86.0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 72 (n=315, 99, 414) | 91.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 276 (n=22, 1, 23) | 95.7 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 192 (n=138, 42, 180) | 91.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 84 (n=309, 92, 401) | 91.8 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 264 (n=59, 5, 64) | 89.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 252 (n=65, 5, 70) | 91.4 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 (n= 378, 105, 483) | 77.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 108 (n=259, 84, 343) | 90.7 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 240 (n=65, 5, 70) | 92.9 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 180 (n=180, 57, 237) | 91.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 120 (n=242, 80, 322) | 90.7 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 228 (n=68, 5, 73) | 90.4 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 168 (n=213, 70, 283) | 90.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 132 (n=232, 79, 311) | 90.4 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 216 (n=76, 13, 89) | 94.4 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 96 (n=281, 87, 368) | 92.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 144 (n=224, 76, 300) | 89.0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 (n=370, 105, 475) | 88.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 24 (n=357, 104, 461) | 89.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 (n=371, 105, 476) | 86.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 36 (n=339, 102, 441) | 92.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 (n=373, 105, 478) | 83.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 204 (n=109, 30, 139) | 92.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 48 (n=331, 102, 433) | 92.4 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 60 (n=323, 102, 425) | 91.8 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 288 (n=3, 0, 3) | 100 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 156 (n=219, 73, 292) | 89.7 Percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 240 (n=65, 5, 70) | 83.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 96 (n=281, 87, 368) | 78.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 168 (n=213, 70, 283) | 79.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 228 (n=68, 5, 73) | 76.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 108 (n=259, 84, 343) | 79.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 24 (n=357, 104, 461) | 76.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 216 (n=76, 13, 89) | 86.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 120 (n=242, 80, 322) | 76.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 (n=371, 105, 476) | 70.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 204 (n=109, 30, 139) | 84.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 132 (n=232, 79, 311) | 77.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 36 (n=339, 102, 441) | 77.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 156 (n=219, 73, 292) | 79.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 144 (n=224, 76, 300) | 78.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 252 (n=65, 5, 70) | 86.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 (n=373, 105, 478) | 63.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 48 (n=331, 102, 433) | 77.3 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 180 (n=180, 57, 237) | 82.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 288 (n=3, 0, 3) | 100 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 60 (n=323, 102, 425) | 77.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 (n= 378, 105, 483) | 59.5 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 276 (n=22, 1, 23) | 81.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 72 (n=315, 99, 414) | 77.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 (n=370, 105, 475) | 70.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 264 (n=59, 5, 64) | 84.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 84 (n=309, 92, 401) | 78.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 192 (n=138, 42, 180) | 79.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 60 (n=323, 102, 425) | 66.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 (n= 378, 105, 483) | 36.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 (n=373, 105, 478) | 35.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 (n=371, 105, 476) | 47.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 (n=370, 105, 475) | 46.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 24 (n=357, 104, 461) | 62.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 36 (n=339, 102, 441) | 56.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 48 (n=331, 102, 433) | 59.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 72 (n=315, 99, 414) | 74.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 84 (n=309, 92, 401) | 64.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 96 (n=281, 87, 368) | 60.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 108 (n=259, 84, 343) | 72.6 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 120 (n=242, 80, 322) | 68.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 132 (n=232, 79, 311) | 72.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 144 (n=224, 76, 300) | 69.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 156 (n=219, 73, 292) | 65.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 192 (n=138, 42, 180) | 61.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 204 (n=109, 30, 139) | 80.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 216 (n=76, 13, 89) | 53.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 228 (n=68, 5, 73) | 80.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 240 (n=65, 5, 70) | 40.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 252 (n=65, 5, 70) | 40.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 264 (n=59, 5, 64) | 40.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 276 (n=22, 1, 23) | 100 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 288 (n=3, 0, 3) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 168 (n=213, 70, 283) | 67.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 180 (n=180, 57, 237) | 71.9 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 216 (n=76, 13, 89) | 82.0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 228 (n=68, 5, 73) | 76.7 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 84 (n=309, 92, 401) | 75.3 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 168 (n=213, 70, 283) | 76.3 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 240 (n=65, 5, 70) | 80.0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 (n=371, 105, 476) | 65.3 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 252 (n=65, 5, 70) | 82.9 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 72 (n=315, 99, 414) | 77.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 (n= 378, 105, 483) | 54.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 264 (n=59, 5, 64) | 81.3 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 60 (n=323, 102, 425) | 74.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 180 (n=180, 57, 237) | 79.7 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 276 (n=22, 1, 23) | 82.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 48 (n=331, 102, 433) | 73.2 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 (n=373, 105, 478) | 57.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 144 (n=224, 76, 300) | 76.0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 132 (n=232, 79, 311) | 75.9 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 288 (n=3, 0, 3) | 100 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 156 (n=219, 73, 292) | 76.0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 36 (n=339, 102, 441) | 72.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 192 (n=138, 42, 180) | 75.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 120 (n=242, 80, 322) | 74.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 24 (n=357, 104, 461) | 73.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 204 (n=109, 30, 139) | 83.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 108 (n=259, 84, 343) | 78.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 (n=370, 105, 475) | 65.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 96 (n=281, 87, 368) | 74.2 Percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 response: greater than or equal to (\>=) 70 percent (%) improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time frame: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Population: Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 (n=370, 105, 475) | 50.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 204 (n=109, 30, 139) | 62.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 96 (n=281, 87, 368) | 59.4 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 (n= 378, 105, 483) | 37.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 192 (n=138, 42, 180) | 63.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 108 (n=259, 84, 343) | 60.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 252 (n=65, 5, 70) | 73.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 180 (n=180, 57, 237) | 63.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 24 (n=357, 104, 461) | 54.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 168 (n=213, 70, 283) | 62.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 132 (n=232, 79, 311) | 60.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 120 (n=242, 80, 322) | 62.0 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 156 (n=219, 73, 292) | 61.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 144 (n=224, 76, 300) | 61.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 288 (n=3, 0, 3) | 66.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 36 (n=339, 102, 441) | 56.6 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 72 (n=315, 99, 414) | 61.9 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 276 (n=22, 1, 23) | 68.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 48 (n=331, 102, 433) | 59.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 (n=371, 105, 476) | 47.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 240 (n=65, 5, 70) | 69.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 60 (n=323, 102, 425) | 59.1 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 (n=373, 105, 478) | 44.8 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 228 (n=68, 5, 73) | 63.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 264 (n=59, 5, 64) | 71.2 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 216 (n=76, 13, 89) | 69.7 Percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 84 (n=309, 92, 401) | 60.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 (n=370, 105, 475) | 16.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 (n= 378, 105, 483) | 19.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 (n=373, 105, 478) | 20.2 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 (n=371, 105, 476) | 21.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 24 (n=357, 104, 461) | 27.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 36 (n=339, 102, 441) | 24.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 48 (n=331, 102, 433) | 34.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 60 (n=323, 102, 425) | 37.3 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 72 (n=315, 99, 414) | 38.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 84 (n=309, 92, 401) | 35.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 96 (n=281, 87, 368) | 42.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 108 (n=259, 84, 343) | 42.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 120 (n=242, 80, 322) | 37.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 132 (n=232, 79, 311) | 40.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 144 (n=224, 76, 300) | 35.5 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 156 (n=219, 73, 292) | 41.1 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 168 (n=213, 70, 283) | 41.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 180 (n=180, 57, 237) | 47.4 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 192 (n=138, 42, 180) | 42.9 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 204 (n=109, 30, 139) | 56.7 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 216 (n=76, 13, 89) | 30.8 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 228 (n=68, 5, 73) | 20.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 240 (n=65, 5, 70) | 20.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 264 (n=59, 5, 64) | 20.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 276 (n=22, 1, 23) | 0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 252 (n=65, 5, 70) | 20.0 Percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 288 (n=3, 0, 3) | 0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 192 (n=138, 42, 180) | 58.9 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 84 (n=309, 92, 401) | 54.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 24 (n=357, 104, 461) | 48.2 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 204 (n=109, 30, 139) | 61.2 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 72 (n=315, 99, 414) | 56.3 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 (n=370, 105, 475) | 42.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 216 (n=76, 13, 89) | 64.0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 60 (n=323, 102, 425) | 53.9 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 288 (n=3, 0, 3) | 66.7 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 228 (n=68, 5, 73) | 60.3 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 48 (n=331, 102, 433) | 53.8 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 (n=371, 105, 476) | 41.8 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 240 (n=65, 5, 70) | 65.7 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 252 (n=65, 5, 70) | 70.0 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 (n=373, 105, 478) | 39.3 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 144 (n=224, 76, 300) | 54.7 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 132 (n=232, 79, 311) | 55.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 264 (n=59, 5, 64) | 67.2 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 156 (n=219, 73, 292) | 56.5 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 120 (n=242, 80, 322) | 55.9 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 36 (n=339, 102, 441) | 49.2 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 168 (n=213, 70, 283) | 57.6 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 108 (n=259, 84, 343) | 56.3 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 (n= 378, 105, 483) | 33.1 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 180 (n=180, 57, 237) | 59.9 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 96 (n=281, 87, 368) | 55.4 Percentage of participants |
| Total | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 276 (n=22, 1, 23) | 65.2 Percentage of participants |