drugset / Trial / NCT02097745

A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

NCT02097745 ↗

Phase 3 Completed 341 enrolled Hoffmann-La Roche Biogen · collab
NaSingle-groupOpen-labelTreatment

Summary

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

Timeline

Start
2004-06
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1 g Intravenous
Background Methotrexate Small molecule 10 mg Oral
Background Methotrexate Small molecule 25 mg Oral

Indications