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| Sponsored by: |
Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00048932 |
Purpose
The purpose of this clinical research study is to learn if BMS-188667 is safe when co-administered with other approved rheumatoid arthritis medications.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Abatacept Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Arms | Assigned Interventions |
|---|---|
| A1: Active Comparator |
Drug: Abatacept
Concentrate and diluted in a solution, IV, 500 mg (BW < 60 Kg); 750 mg (BW 60-100 Kg); 1000 mg (BW > 100 Kg), Once daily, Day 1, 15, and 29.
|
| A2: Placebo Comparator |
Drug: Placebo
Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.
|
| B: Active Comparator |
Drug: Abatacept
Concentrate and diluted in a solution, IV, 500 mg (BW < 60 Kg); 750 mg (BW 60-100 Kg); 1000 mg (BW > 100 Kg), Once daily, Every 28 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion:
Contacts and Locations
Show 44 Study Locations
More Information
| Study ID Numbers: | IM101-031 |
| Study First Received: | November 11, 2002 |
| Last Updated: | September 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00048932 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Abatacept Autoimmune Diseases Immunologic Factors Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Antirheumatic Agents Immunosuppressive Agents |
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Autoimmune Diseases Immunologic Factors Immune System Diseases Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid Rheumatic Diseases Immunosuppressive Agents |
Pharmacologic Actions Abatacept Musculoskeletal Diseases Arthritis Therapeutic Uses Connective Tissue Diseases Antirheumatic Agents |