drugset / Trial / NCT01211834

Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

NCT01211834

Phase 3 Completed 90 enrolled JW Pharmaceutical
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment

Timeline

Start
2009-10
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Comparator Azathioprine Small molecule
Comparator Chloroquine Small molecule
Comparator Hydroxychloroquine Small molecule
Comparator Leflunomide Small molecule
Comparator Methotrexate Small molecule
Comparator Sulfasalazine Small molecule

Indications