Status:
COMPLETED
Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis
Lead Sponsor:
Centocor, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody \[cA2\]) in patients with active Rheumatoid Arthritis, despite methotrexat...
Detailed Description
This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite methotrexate treatm...
Eligibility Criteria
Inclusion
- Patients with active Rheumatoid Arthritis despite treatment with methotrexate
- Diagnosed with Rheumatoid Arthritis at least 6 months prior to screening
- Having active disease at the time of screening and pre-infusion as defined by having at least 6 or more swollen joints and 6 or more tender joints
- Using methotrexate for at least 3 months prior to study enrollment
Exclusion
- Patients having any systemic inflammatory condition
- Having Lyme disease or a rheumatic disease other than Rheumatoid Arthritis
- Who have used Disease-Modifying Antirheumatic Drugs (DMARDs) other than methotrexate within 4 weeks prior to screening
- Who have used corticosteroids within 4 weeks prior to screening
- Having received previous administration of infliximab
Key Trial Info
Start Date :
March 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2000
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT00269867
Start Date
March 1 1997
End Date
March 1 2000
Last Update
November 4 2014
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