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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00484289 |
The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis having completed clinical studies IM101071, IM101034, and also DMARDs failures with MTX intolerance.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Abatacept |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase III, Multi-Center, Open-Label, Uncontrolled, Long-Term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101071, IM101034, and Also Special DMARD Failures |
Estimated Enrollment: | 180 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Abatacept
Vials (250 mg/vial), IV, 10 mg/kg, monthly infusion, until approved in Japan
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | IM101-129 |
Study First Received: | June 7, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00484289 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Abatacept Autoimmune Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immunologic Factors Immune System Diseases Therapeutic Uses Physiological Effects of Drugs |
Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |