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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00048568 |
The purpose of this clinical research study is to learn if BMS-188667 in combination with methotrexate is better than methotrexate alone in subjects that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: BMS-188667 Drug: Methotrexate Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator) |
Arms | Assigned Interventions |
---|---|
A1: Experimental |
Drug: BMS-188667
IV Solution, Intravenous, - Weight Titered (500 mg < 60 kg); (750 mg 60-100 kg), )1 gram > 100 kg), Day 1, Day 15, Day 29; every 18 days thereafter, 1 year (+LTE)
Drug: Methotrexate
Tablets, Oral, >= 15 mg, weekly, 1 year (+LTE)
|
A2: Placebo Comparator |
Drug: Methotrexate
Tablets, Oral, >= 15 mg, weekly, 1 year (+LTE)
Drug: Placebo
IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | IM101-102 |
Study First Received: | November 2, 2002 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00048568 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Folic Acid Antagonists Immunosuppressive Agents |
Folic Acid Abatacept Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Abatacept Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |