drugset / Trial / NCT02079532

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

NCT02079532 ↗

Phase 3 Completed 302 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Timeline

Start
2006-11
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1 g Intravenous

Indications