Rheumatoid Arthritis Clinical Trial
Official title:
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes
Verified date | March 2012 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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 better understanding of how this treatment
affects the inflamed joints of rheumatoid arthritis (RA) patients.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Arthritis Centre, University of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Hoffmann-La Roche |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis | Biopsies of inflamed joint at beginning and at week 8 of study | No | |
Secondary | To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells | Collected at beginning of study and week 8 | No |
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