Status:
COMPLETED
Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) pat...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR)
- Disease duration of 6 months or more
- Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug
- Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL
- Exclusion criteria
- Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug
- Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug
- Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug.
- Administration of any DMARD or immunosuppressant other than MTX
- Administration of corticosteroids exceeding 10 mg/day as prednisolone
- Dose escalation or initiation of corticosteroids
- Received any of the following therapies in the 4 weeks preceding treatment with the study drug
- Plasma exchange therapy
- Surgical treatment (operation, etc.)
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00144521
Start Date
February 1 2004
End Date
April 1 2006
Last Update
February 2 2009
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