Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

Key facts

Study ID

NCT00124449

Run by

Bristol-Myers Squibb

People needed

56

Starts

2005-02-01

Expected to finish

2008-04-01

Last updated by the study team

2015-04-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of undifferentiated arthritis
• Clinical synovitis of two or more joints
• At least one but not more than three of the criteria for diagnosis of RA (1987).
• No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
• Duration of disease must be 18 months or less.
• Positive for antibodies against cyclic citrullinated peptides.

You may not qualify if…

• Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy.
• Active vasculitis of a major organ system.
• Severe or recurrent bacterial infection.
• History of cancer in the last five years except certain skin cancers.
• Herpes zoster that resolved less than 2 months prior to enrollment

Where it is running

• Local Institution — Huntsville, Alabama, United States
• Local Institution — Mobile, Alabama, United States
• Local Institution — Huntington Beach, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Boulder, Colorado, United States
• Local Institution — Colorado Springs, Colorado, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Evansville, Indiana, United States
• Local Institution — New Orleans, Louisiana, United States
• Local Institution — Cumberland, Maryland, United States
• Local Institution — Hagerstown, Maryland, United States
• Local Institution — Duluth, Minnesota, United States
• Local Institution — Durham, North Carolina, United States
• Local Institution — Wilmington, North Carolina, United States
• Local Institution — Oklahoma City, Oklahoma, United States
• Local Institution — Willow Grove, Pennsylvania, United States
• Local Institution — Charleston, South Carolina, United States
• Local Institution — Austin, Texas, United States
• Local Institution — Arlington, Virginia, United States
• Local Institution — Cairns, Queensland, Australia
• Local Institution — Clayton, Victoria, Australia
• Local Institution — Malvern, Victoria, Australia
• Local Institution — Shenton Park, Western Australia, Australia
• Local Institution — Brussels, Belgium

Full record on ClinicalTrials.gov

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