A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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 arthritis (RA) who were receiving background methotrexate (MTX).

Key facts

Study ID

NCT00282308

Run by

Genentech, Inc.

People needed

103

Starts

2006-01-23

Expected to finish

2012-05-28

Last updated by the study team

2017-08-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA; Sjogren's syndrome with RA is permitted.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Arizona Arthritis & Rheumatology Research, Pllc — Paradise Valley, Arizona, United States
• Sun Valley Arthritis Center — Peoria, Arizona, United States
• Desert Medical Advances — Palm Desert, California, United States
• Inland Rheumatology; Clinical Trials, Inc. — Upland, California, United States
• Arthritis Associates of South Florida — Delray Beach, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• Center For Arthritis; Research Dept — South Miami, Florida, United States
• Intermountain Orthopaedics — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Univ of Chicago — Chicago, Illinois, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Kentuckiana Center For Better Bone & Joint Healthx — Louisville, Kentucky, United States
• Clinical Research Network — Slidell, Louisiana, United States
• Johns Hopkins University; Rheumatology — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Rheumatology, P.C.; Medical Arts Building — Kalamazoo, Michigan, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• Justus Fiechtner MD - PP — Lansing, Michigan, United States
• Center for Rheumatology, State Uni. of New York — Albany, New York, United States
• Aair Research Center — Rochester, New York, United States
• University of Rochester - Strong Memorial Hospital — Rochester, New York, United States
• Physicians East Pa — Greenville, North Carolina, United States
• Health Research of Oklahoma, Llc — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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