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

Phase 2 Completed 103 enrolled Genentech, Inc.

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2006-01-23
Primary completion: 2008-01-31
Completion: 2012-05-28

Publications

Bingham CO 3rd, Looney RJ, Deodhar A, Halsey N, Greenwald M, Codding C, Trzaskoma B, Martin F, Agarwal S, Kelman A. Immunization responses in rheumatoid arthritis patients treated with rituximab: results from a controlled clinical trial. Arthritis Rheum. 2010 Jan;62(1):64-74. doi: 10.1002/art.25034.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pneumovax 23	Vaccine	0.5 ml	Intramuscular
Subject	Rituximab	Monoclonal antibody	1000 mg	Intravenous
Subject	Tetanus toxoid adsorbed booster vaccine	Vaccine	1 mg	Intramuscular
Subject	keyhole limpet hemocyanin	Vaccine	1 mg	Subcutaneous
Background	Methotrexate	Small molecule	10 mg	Oral
Background	Methotrexate	Small molecule	25 mg	Oral
Background	Methylprednisone	Unknown	100 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications