A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate (SIERRA)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, Rituxan, SIERRA
Eligibility Criteria
Inclusion Criteria: 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 Criteria: Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA; Sjogren's syndrome with RA is permitted.
Sites / Locations
- Univ of Alabama at Birmingham
- Arizona Arthritis & Rheumatology Research, Pllc
- Sun Valley Arthritis Center
- Desert Medical Advances
- Inland Rheumatology; Clinical Trials, Inc.
- Arthritis Associates of South Florida
- The Arthritis Center
- Center For Arthritis; Research Dept
- Intermountain Orthopaedics
- Northwestern University
- Univ of Chicago
- Evanston Northwestern Healthcare
- Springfield Clinic
- Kentuckiana Center For Better Bone & Joint Healthx
- Clinical Research Network
- Johns Hopkins University; Rheumatology
- Dana Farber Cancer Institute
- Rheumatology, P.C.; Medical Arts Building
- Borgess Research Institute
- Justus Fiechtner MD - PP
- Center for Rheumatology, State Uni. of New York
- Aair Research Center
- University of Rochester - Strong Memorial Hospital
- Physicians East Pa
- Health Research of Oklahoma, Llc
- Oregon Health Sciences Uni
- Altoona Arthritis & Osteo Center
- University of Pennsylvania
- Rheumatology Associates
- Medical University of S. Carolina
- Arthritis Associates
- Arthritis Care & Diagnostic Center
- Arthritis Clinic of Northern Virginia
- Arthritis Northwest, Spokane
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rituximab + methotrexate (Group A)
Methotrexate (Group B)
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.