drugset / Trial / NCT00502840

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

NCT00502840 ↗

Phase 3 Completed 193 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 \>2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Timeline

Start
2007-07-23
Primary completion
2011-09-20
Completion
2011-09-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1 g Intravenous

Indications