drugset / Trial / NCT01010503

A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

NCT01010503

Phase 4 Completed 32 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

Timeline

Start
2009-06
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications