Status:
COMPLETED
Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ris...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00124449
Start Date
February 1 2005
End Date
April 1 2008
Last Update
April 7 2015
Active Locations (48)
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1
Local Institution
Huntsville, Alabama, United States
2
Local Institution
Mobile, Alabama, United States
3
Local Institution
Huntington Beach, California, United States
4
Local Institution
Los Angeles, California, United States