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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00124982 |
The purpose of this study is to learn if Abatacept will provide clinical efficacy to subjects who have failed an anti-TNF therapy. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Abatacept |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options |
Estimated Enrollment: | 1000 |
Study Start Date: | April 2005 |
Study Completion Date: | January 2007 |
Arms | Assigned Interventions |
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A1: Experimental |
Drug: Abatacept
IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study ID Numbers: | IM101-064 |
Study First Received: | June 30, 2005 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00124982 |
Health Authority: | United States: Food and Drug Administration |
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 |