Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Arthritis Centre, University of Manitoba
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab
Arm Description
Outcomes
Primary Outcome Measures
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis
Secondary Outcome Measures
To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells
Full Information
NCT ID
NCT00963703
First Posted
August 20, 2009
Last Updated
March 19, 2012
Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00963703
Brief Title
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
Official Title
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 1000 mg Intravenously day 1 and day 15
Primary Outcome Measure Information:
Title
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis
Time Frame
Biopsies of inflamed joint at beginning and at week 8 of study
Secondary Outcome Measure Information:
Title
To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells
Time Frame
Collected at beginning of study and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Arthritis Centre, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
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