drugset
drugset / Trial / NCT00243412

A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate

NCT00243412 ↗

Phase 2 Completed 42 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of rituximab, administered at two different regimens for 2 years, in patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of methotrexate (MTX).

Timeline

Start
2005-08
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 500 mg Intravenous
Subject Rituximab Monoclonal antibody 1000 mg Intravenous
Background Leucovorin Small molecule 5 mg Oral
Background Methotrexate Small molecule 10 mg Oral
Background Methotrexate Small molecule 14 mg Oral
Background Methotrexate Small molecule 15 mg Oral
Background Methotrexate Small molecule 25 mg Oral
Background Methylprednisolone Other / unclassified 100 mg Intravenous
Background folic acid Small molecule 1 mg Oral

Indications

rheumatoid arthritis