Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
NCT ID: NCT00963703
Last Updated: 2012-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2007-12-31
2012-03-31
Brief Summary
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This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab
Rituximab
Rituximab 1000 mg Intravenously day 1 and day 15
Interventions
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Rituximab
Rituximab 1000 mg Intravenously day 1 and day 15
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
University of Manitoba
OTHER
Responsible Party
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Arthritis Centre, Unversity of Manitoba
Locations
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Arthritis Centre, University of Manitoba
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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B2007:160
Identifier Type: -
Identifier Source: org_study_id
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