Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan
- Registration Number
- NCT00661661
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 487
- Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis
- Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CP-690,550 CP-690,550 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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).
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).
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 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).
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).
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 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) 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).
Trial Locations
- Locations (56)
Chiba-ken Saiseikai Narashino Hospital
🇯🇵Narashino, Chiba, Japan
National hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Aichi, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Aso Iizuka Hospital
🇯🇵Iiduka, Fukuoka, Japan
University of Occupational and Environmental Health Hospital
🇯🇵Kitakyusyu, Fukuoka, Japan
St. Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
SHONO Rheumatism Clinic
🇯🇵Sawara-ku, Fukuoka, Japan
Inoue Hospital
🇯🇵Takasaki, Gunma, Japan
Higashihiroshima Memorial Hospital
🇯🇵Higashihiroshima, Hiroshima, Japan
National Hospital Organization MURAYAMA Medical Center
🇯🇵Musashimurayama-shi, Tokyo, Japan
National Hospital Organization Chiba-East Hospital
🇯🇵Chiba, Japan
Kondo clinic for rheumatism and orthopaedics
🇯🇵Fukuoka, Japan
Kumamoto Orthopaedic Hospital
🇯🇵Kumamoto, Japan
University Hospital, Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Saitama city hospital
🇯🇵Saitama, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Shimoshizu National Hospital
🇯🇵Yotukaidou, Chiba, Japan
Fukusima Daiichi Hospital
🇯🇵Fukusima, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Ohmura, Nagasaki, Japan
Sapporo city general hospital
🇯🇵Sapporo, Hokkaido, Japan
The Hospital of Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Taga General Hospital
🇯🇵Hitachi-shi, Ibaraki, Japan
National Hospital Organization Sagamihara National Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Kumamoto Saishunso National Hospital
🇯🇵Koushi, Kumamoto, Japan
Hikarigaoka Spellman Hospital
🇯🇵Sendai, Miyagi, Japan
National Hospital Organization Osaka Minami Center
🇯🇵Kawachinagano, Osaka, Japan
Kitasato University Kitasato Institute Medical Center Hospital
🇯🇵Kitamoto, Saitama, Japan
National hospital Organization Mie Chuou Medical Center
🇯🇵Tsu, Mie, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Tokyo Women's Medical University Medical Center East
🇯🇵Arakawa-ku, Tokyo, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine
🇯🇵Bunkyo-ku, Tokyo, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Juntendo Tokyo Koto Geriatric Medical Center
🇯🇵Koto-ku, Tokyo, Japan
Sasaki Foundation Kyoundo Hospital
🇯🇵Chiyoda-ku, Tokyo, Japan
Saitama Medical Center
🇯🇵Kawagoe-shi, Saitama, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
🇯🇵Hiroshima-city, Hiroshima, Japan
Sasebo Chuo Hospital
🇯🇵Sasebo, Nagasaki, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hokkaido Medical Center for Rheumatic Diseases
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Ureshino Medical Center
🇯🇵Ureshino, Saga, Japan
Higami hospital
🇯🇵Kashihara, Nara, Japan
Katayama Orthopedic Rheumatology Clinic
🇯🇵Asahikawa, Hokkaido, Japan
Tsukuba University Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Tokyo Women's Medical University, Institute of Rheumatology
🇯🇵Shinjyuku-ku, Tokyo, Japan
Hiroshima Rheumatology Clinic
🇯🇵Hiroshima, Japan
The Tazuke Kofukai Medical Research Institute Kitano Hospital
🇯🇵Osaka, Japan
Nagasaki University Hospital of Medicine and Dentistry
🇯🇵Nagasaki, Japan
Sendai Taihaku Hospital
🇯🇵Miyagi, Japan
Fukuhara Hospital
🇯🇵Setagaya-ku, Tokyo, Japan
Medical Co.LTA PS Clinic
🇯🇵Fukuoka, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
A Medical Corporation Oribe Rheumatism Internist Clinic
🇯🇵Oita, Japan