Remission and Joint Damage Progression in Early Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

Key facts

Study ID

NCT00122382

Run by

Bristol-Myers Squibb

People needed

1052

Starts

2005-07-01

Expected to finish

2009-02-01

Last updated by the study team

2010-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3 weeks. No dose within 3 months prior to informed consent.
• C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)
• Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
• Tender joints >=12 and swollen joints >=10

You may not qualify if…

• Women and men who are not willing to use birth control
• Diagnosed with other rheumatic disease
• History of cancer within 5 years
• Active tuberculosis
• Treatment with another investigation drug within 28 days
• Active bacterial or viral infection

Where it is running

• Talbert Medical Group — Huntington Beach, California, United States
• Arthritis Assoc And Osteo Ctr Of Col Sprgs — Colorado Springs, Colorado, United States
• New England Research Associates, Llc — Trumbull, Connecticut, United States
• Diagnostic Rheumatology And Research — Indianapolis, Indiana, United States
• Osteoporosis And Clinical Trials Center — Cumberland, Maryland, United States
• Malamet & Klein, Md, Pa — Hagerstown, Maryland, United States
• Arthritis Center Of Nebraska — Lincoln, Nebraska, United States
• Regional Rheumatology Associates — Binghamton, New York, United States
• Carolina Bone & Joint — Charlotte, North Carolina, United States
• Physicians East, Pa — Greenville, North Carolina, United States
• Carolina Pharmaceutical Research — Statesville, North Carolina, United States
• Lion Research — Norman, Oklahoma, United States
• Health Research Of Oklahoma — Oklahoma City, Oklahoma, United States
• Lynn Health Sciences Institute — Oklahoma City, Oklahoma, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Low Country Research Center — Charleston, South Carolina, United States
• Walter F Chase Md Pa — Austin, Texas, United States
• Arthritis Clinic Of Northern Virginia, P.C. — Arlington, Virginia, United States
• Local Institution — Malvern, Victoria, Australia
• Local Institution — Shenton Park, Western Australia, Australia
• Local Institution — Antwerp, Belgium
• Local Institution — Brussels, Belgium
• Local Institution — Brussels, Belgium
• Local Institution — Hasselt, Belgium
• Rheumatology Associates Of North Alabama — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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