drugset / Trial / NCT01251120

A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

NCT01251120

Phase 4 Terminated 2 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.

Timeline

Start
2011-11
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Comparator Methotrexate Small molecule

Indications