Status:
COMPLETED
A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Lead Sponsor:
Genentech, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arth...
Detailed Description
Patients were randomized to 2 groups in this study: Group A (active group) and Group B (control group). Patients with active rheumatic arthritis treated with rituximab in combination with methotrexate...
Eligibility Criteria
Inclusion
- Age 18-65 years.
- Diagnosis of rheumatoid arthritis (RA) for at least 6 months.
- Receiving treatment for RA on an outpatient basis.
- Use of methotrexate (MTX) at a dose of 10-25 mg/wk (oral \[PO\] or subcutaneous \[SC\]) for at least 12 weeks prior to Day 1, with the dose stable during the last 4 weeks prior to Day 1 (first day of the treatment period).
- If taking a background corticosteroid, use of the corticosteroid must be for at least 12 weeks prior to Day 1 at a stable dose during the last 4 weeks prior to Day 1.
- If taking one non-steroidal anti-inflammatory drug (NSAID), use of a stable dose for at least 2 weeks prior to Day 1.
Exclusion
- Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA; Sjogren's syndrome with RA is permitted.
Key Trial Info
Start Date :
January 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2012
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00282308
Start Date
January 23 2006
End Date
May 28 2012
Last Update
August 10 2017
Active Locations (34)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, United States, 85253
3
Sun Valley Arthritis Center
Peoria, Arizona, United States, 85381
4
Desert Medical Advances
Palm Desert, California, United States, 92260