drugset / Trial / NCT00424502

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

NCT00424502

Phase 4 Completed 20 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Timeline

Start
2007-01
Primary completion
2009-10
Completion
2009-10

Drugs

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

Indications