Status:
COMPLETED
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.
Eligibility Criteria
Inclusion
- Diagnosis of Rheumatoid Arthritis
- At least 3 months prior treatment with Methotrexate (MTX)
- At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
- Washout required for other disease modifying anti-rheumatic drugs (DMARDS)
Exclusion
- participants who have failed more than 3 DMARDs
- participants previously treated with an approved biologic drug
- History of cancer in the last 5 years
- Severe or recurrent bacterial infection
- Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
- Women of Child Bearing Potential
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT00095147
Start Date
February 1 2005
End Date
July 1 2009
Last Update
March 24 2015
Active Locations (76)
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1
Local Institution
Huntsville, Alabama, United States
2
Local Institution
Denver, Colorado, United States
3
Local Institution
Boca Raton, Florida, United States
4
Local Institution
Fort Lauderdale, Florida, United States