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

Completed · Phase 1/Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT00279760

Run by

Bristol-Myers Squibb

People needed

210

Last updated by the study team

2016-09-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Local Institution — Huntsville, Alabama, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution — Tucson, Arizona, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — Miami, Florida, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Boston, Massachusetts, United States
• Local Institution — Duluth, Minnesota, United States
• Local Institution — New Brunswick, New Jersey, United States
• Local Institution — New York, New York, United States
• Local Institution — Chapel Hill, North Carolina, United States
• Local Institution — Cincinnati, Ohio, United States
• Local Institution — Cleveland, Ohio, United States
• Local Institution — Portland, Oregon, United States
• Local Institution — Nashville, Tennessee, United States
• Local Institution — Dallas, Texas, United States
• Local Institution — Salt Lake City, Utah, United States
• Local Institution — Seattle, Washington, United States
• Local Instiution — Brussels, Belgium
• Local Institution — Diepenbeek, Belgium
• Local Institution — Ghent, Belgium
• Local Institution — Liège, Belgium
• Local Institution — Mons, Belgium
• Local Institution — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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