A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
NCT00048932 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1795
Last updated 2011-11-24
Summary
The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.
Conditions
Interventions
- DRUG
-
Double-blind Abatacept
Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Day 1, 15, and 29.
- DRUG
-
Double-blind Placebo
Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.
- DRUG
-
Open-label Abatacept
Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Every 28 days.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-12-31
- Primary Completion
- 2009-10-31
- Completion
- 2009-10-31
Countries
- United States
Study Locations
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