Rheumatoid Arthritis Clinical Trial
Official title:
A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis
Verified date | April 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 487 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Tokyo Women's Medical University Medical Center East | Arakawa-ku | Tokyo |
Japan | Katayama Orthopedic Rheumatology Clinic | Asahikawa | Hokkaido |
Japan | Juntendo University Hospital | Bunkyo-ku | Tokyo |
Japan | The University of Tokyo Hospital | Bunkyo-ku | Tokyo |
Japan | Tokyo Medical And Dental University Hospital, Faculty of Medicine | Bunkyo-ku | Tokyo |
Japan | National Hospital Organization Chiba-East Hospital | Chiba | |
Japan | Sasaki Foundation Kyoundo Hospital | Chiyoda-ku | Tokyo |
Japan | Kondo clinic for rheumatism and orthopaedics | Fukuoka | |
Japan | Medical Co.LTA PS Clinic | Fukuoka | |
Japan | National Hospital Organization Kyushu Medical Center | Fukuoka | |
Japan | Fukusima Daiichi Hospital | Fukusima | |
Japan | Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka |
Japan | Higashihiroshima Memorial Hospital | Higashihiroshima | Hiroshima |
Japan | Hiroshima Rheumatology Clinic | Hiroshima | |
Japan | Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Hiroshima-city | Hiroshima |
Japan | Taga General Hospital | Hitachi-shi | Ibaraki |
Japan | Aso Iizuka Hospital | Iiduka | Fukuoka |
Japan | Higami hospital | Kashihara | Nara |
Japan | National Hospital Organization Osaka Minami Center | Kawachinagano | Osaka |
Japan | Saitama Medical Center | Kawagoe-shi | Saitama |
Japan | University of Occupational and Environmental Health Hospital | Kitakyusyu | Fukuoka |
Japan | Kitasato University Kitasato Institute Medical Center Hospital | Kitamoto | Saitama |
Japan | Juntendo Tokyo Koto Geriatric Medical Center | Koto-ku | Tokyo |
Japan | Kumamoto Saishunso National Hospital | Koushi | Kumamoto |
Japan | Kumamoto Orthopaedic Hospital | Kumamoto | |
Japan | St. Mary's Hospital | Kurume | Fukuoka |
Japan | Kyoto University Hospital | Kyoto | |
Japan | University Hospital, Kyoto Prefectural University of Medicine | Kyoto | |
Japan | National Hospital Organization Tokyo Medical Center | Meguro-ku | Tokyo |
Japan | Sendai Taihaku Hospital | Miyagi | |
Japan | National Hospital Organization MURAYAMA Medical Center | Musashimurayama-shi | Tokyo |
Japan | Nagasaki University Hospital of Medicine and Dentistry | Nagasaki | |
Japan | Nagoya University Hospital | Nagoya | Aichi |
Japan | National hospital Organization Nagoya Medical Center | Nagoya | Aichi |
Japan | Chiba-ken Saiseikai Narashino Hospital | Narashino | Chiba |
Japan | Niigata University Medical & Dental Hospital | Niigata | |
Japan | The Hospital of Hyogo College of Medicine | Nishinomiya | Hyogo |
Japan | National Hospital Organization Nagasaki Medical Center | Ohmura | Nagasaki |
Japan | A Medical Corporation Oribe Rheumatism Internist Clinic | Oita | |
Japan | The Tazuke Kofukai Medical Research Institute Kitano Hospital | Osaka | |
Japan | National Hospital Organization Sagamihara National Hospital | Sagamihara | Kanagawa |
Japan | Saitama city hospital | Saitama | |
Japan | Hokkaido Medical Center for Rheumatic Diseases | Sapporo | Hokkaido |
Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
Japan | Sapporo city general hospital | Sapporo | Hokkaido |
Japan | Sasebo Chuo Hospital | Sasebo | Nagasaki |
Japan | SHONO Rheumatism Clinic | Sawara-ku | Fukuoka |
Japan | Hikarigaoka Spellman Hospital | Sendai | Miyagi |
Japan | Fukuhara Hospital | Setagaya-ku | Tokyo |
Japan | Keio University Hospital | Shinjuku-ku, Tokyo | |
Japan | Tokyo Women's Medical University, Institute of Rheumatology | Shinjyuku-ku | Tokyo |
Japan | Inoue Hospital | Takasaki | Gunma |
Japan | National hospital Organization Mie Chuou Medical Center | Tsu | Mie |
Japan | Tsukuba University Hospital | Tsukuba | Ibaraki |
Japan | Ureshino Medical Center | Ureshino | Saga |
Japan | Shimoshizu National Hospital | Yotukaidou | Chiba |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Baseline up to Week 288 | Yes |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | 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 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 | No |
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. | First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96 | No |
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