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

Study Timeline

• Primary Completion: 2002-03
• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-20
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

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