drugset / Trial / NCT02006706

A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

NCT02006706 ↗

Phase 3 Completed 15 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

Timeline

Start
2006-08-10
Primary completion
2007-11-23
Completion
2007-11-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 10 mg Oral
Subject Methotrexate Small molecule 25 mg Oral
Subject Rituximab Monoclonal antibody 1000 mg Intravenous
Background Methylprednisolone Other / unclassified — Intravenous

Indications