Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

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