Status:
COMPLETED
Remission and Joint Damage Progression in Early Rheumatoid Arthritis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
1052 Patients enrolled
Trial Details
Trial ID
NCT00122382
Start Date
July 1 2005
End Date
February 1 2009
Last Update
November 16 2010
Active Locations (89)
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1
Rheumatology Associates Of North Alabama
Huntsville, Alabama, United States, 35801
2
Talbert Medical Group
Huntington Beach, California, United States, 92646
3
Arthritis Assoc And Osteo Ctr Of Col Sprgs
Colorado Springs, Colorado, United States, 80910
4
New England Research Associates, Llc
Trumbull, Connecticut, United States, 06611