drugset / Trial / NCT00266227

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate

NCT00266227

Phase 3 Completed 559 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid arthritis (RA) who are receiving Methotrexate (MTX).

Timeline

Start
2006-01
Primary completion
2007-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1000 mg Intravenous
Background Methotrexate Small molecule 10 mg Oral
Background Methotrexate Small molecule 25 mg Oral
Background folic acid Small molecule Intravenous

Indications