Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
Phase 1
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00279760
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and BMS-224818 in subjects with RA
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
- Diagnosis of RA < 5 years
- Functional class I, II, or II as defined by the American College of Rheumatology (ACR) criteria.
- Must have failed at least 1 Disease Modifying Anit-Rheumatic Drug (DMARD)
- Joint count of 10 or more swollen and 12 or more tender.
- Erythrocyte Sedimentation Rate (ESR) > - 28mm/rr or norning stiffness > - 45 minutes.
Exclusion Criteria
- Women and men who are not willing to use an accepted form of contraception.
- Active vasculitis
- Treatment with another investigational drug within 30 days
- History of asthma, angioedema, or anaphylaxix
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
- Secondary Outcome Measures
Name Time Method Assess the immunogenicity of BMS-188667 and BMS-224818 in subjects with RA, and in a site specific substudy to the protocol, the pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-188667 and BMS-224818 in subjects with RA
Trial Locations
- Locations (2)
Local Institution
🇬🇧Leeds, United Kingdom
Local Instiution
🇧🇪Bruxelles, Belgium