drugset / Trial / NCT00996203

A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

NCT00996203

Phase 4 Completed 201 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

Timeline

Start
2009-10-31
Primary completion
2011-02-14
Completion
2011-02-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications