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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Belatacept; Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00279760

IM103-002

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind