Status:
COMPLETED
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells. This will allow the investigators to get a b...
Eligibility Criteria
Inclusion
- Patients with documented rheumatoid arthritis by ACR criteria
- Disease duration \< 5 years
- May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
- Tender joint count \>= 6, swollen joint count \>= 6, and one must be a knee
- Corticosteroids \<= 10 mg per day permitted on stable doses for at least 4 weeks
- Patients must consent to 2 arthroscopic synovial biopsy procedures
Exclusion
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- Previous treatment with Rituximab
- Previous treatment with Arava
- Injected with steroids within 4 weeks of day 1 of study
- Treatment with any investigational agent within 4 weeks of day of study
- Any severe or significant medical condition or disease or known active infection
- Pregnancy or nursing at present
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00963703
Start Date
December 1 2007
End Date
March 1 2012
Last Update
March 20 2012
Active Locations (1)
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1
Arthritis Centre, University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1M4