Status:
COMPLETED
Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00279760
Last Update
September 16 2016
Active Locations (60)
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1
Local Institution
Birmingham, Alabama, United States
2
Local Institution
Huntsville, Alabama, United States
3
Local Institution
Phoenix, Arizona, United States
4
Local Institution
Tucson, Arizona, United States