- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [ 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 ]
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).
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ 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 ]
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 [ 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 ]
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 [ 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 ]
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]) [ 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 ]
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]) [ 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 ]
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 [ 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 ]
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 [ 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 ]
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 [ 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 ]
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 [ 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 ]
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 [ 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 ]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning [ Time Frame: 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 Physical [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
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