Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
1 other identifier
interventional
15
1 country
1
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 better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
Started Dec 2007
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 20, 2012
March 1, 2012
4.3 years
August 20, 2009
March 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (1)
Rituximab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Hoffmann-La Rochecollaborator
Study Sites (1)
Arthritis Centre, University of Manitoba
Winnipeg, Manitoba, R3A 1M4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 21, 2009
Study Start
December 1, 2007
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
March 20, 2012
Record last verified: 2012-03