Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bristol-Myers Squibb |
---|---|
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00048581 |
The purpose of this clinical research study is to determine whether BMS-188667 will relieve the symptoms of rheumatoid arthritis in patients who are currently receiving anti-TNF therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with BMS-188667 will also be evaluated.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Abatacept Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background DMARDS Who Have Failed Anti-TNF Therapy |
Estimated Enrollment: | 393 |
Study Start Date: | December 2002 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Abatacept
Vials, IV, ~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
|
2: Placebo Comparator |
Drug: Placebo
Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility Criteria:
Exclusion Criteria:
Study ID Numbers: | IM101-029 |
Study First Received: | November 2, 2002 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00048581 |
Health Authority: | United States: Food and Drug Administration |
Abatacept Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Cytotoxic T-lymphocyte antigen 4 |
Immunologic Factors Immune System Diseases Therapeutic Uses Physiological Effects of Drugs |
Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |