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The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept 2 mg/kg | Active Comparator |
| |
| Abatacept 10 mg/kg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy will be evaluated using the American College of Rheumatology response rate or ACR 20. This means the respective proportion of patients reaching an improvement of at least 20% of the ACR composite index from baseline. | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ACR 50 and ACR 70 will be assessed as respectively 50 and 70% improvement of the ACR composite index, quality of life by using SF36 questionnaire, Population Pharmacokinetics, Biomarkers, Immunogenicity | at 6 months | |
| Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Local Institution |
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| Placebo | Drug | Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks |
|
| at 6 months |
| Nagoya |
| Aichi-ken |
| 466-8550 |
| Japan |
| Local Institution | Goshogawara-Shi | Aomori | 037-0053 | Japan |
| Local Institution | Chiba | Chiba | Japan |
| Local Institution | Fukui-shi | Fukui | 910-0041 | Japan |
| Local Institution | Fukui-shi | Fukui | 910-0067 | Japan |
| Local Institution | Fukuoka | Fukuoka | 810-0065 | Japan |
| Local Institution | Fukuoka | Fukuoka | 812-0025 | Japan |
| Local Institution | Kitakyushu-Shi | Fukuoka | 807-8555 | Japan |
| Local Institution | Higashi-Hiroshima-Shi | Hiroshima | 739-0002 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-0001 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-8604 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-8648 | Japan |
| Local Institution | Kanzaki-Gun | Hyōgo | 679-2414 | Japan |
| Local Institution | Kato-Gun | Hyōgo | 673-1462 | Japan |
| Local Institution | Hitachi-Shi | Ibaraki | 316-0035 | Japan |
| Local Institution | Tsukuba | Ibaraki | 305-0005 | Japan |
| Local Institution | Sagamihara-Shi | Kanagawa | 228-8522 | Japan |
| Local Institution | Sendai | Miyagi | 981-0911 | Japan |
| Local Institution | Sendai | Miyagi | 982-0032 | Japan |
| Local Institution | Sendai | Miyagi | Japan |
| Local Institution | Nagano | Nagano | 380-8582 | Japan |
| Local Institution | Tsukubo-Gun | Okayama-ken | 701-0304 | Japan |
| Local Institution | Kawachinagano-Shi | Osaka | 86-0008 | Japan |
| Local Institution | Ureshino-Shi | Saga-ken | 843-0301 | Japan |
| Local Institution | Iruma-Gun | Saitama | 350-0495 | Japan |
| Local Institution | Kawagoe-Shi | Saitama | 350-8550 | Japan |
| Local Institution | Kitamoto-Shi | Saitama | 364-0026 | Japan |
| Local Institution | Hamamatsu | Shizuoka | 430-0906 | Japan |
| Local Institution | Kawachigun | Tochigi | 329-1104 | Japan |
| Local Institution | Tochigi | Tochigi | 329-0498 | Japan |
| Local Institution | Arakawa-Ku | Tokyo | 116-0011 | Japan |
| Local Institution | Bunkyo-Ku | Tokyo | 113-0022 | Japan |
| Local Institution | Bunkyo-Ku | Tokyo | 113-8519 | Japan |
| Local Institution | Setagaya-Ku | Tokyo | 155-0032 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 162-0054 | Japan |
| Local Institution | Takaoka-Shi | Toyama | 933-8525 | Japan |
| Local Institution | Chiba | 260-0801 | Japan |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
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