drugset / Trial / NCT01148810

Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

NCT01148810

Phase 2 Terminated 18 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects received BAF312 treatment.

Timeline

Start
2010-06-15
Primary completion
2012-06-13
Completion
2012-06-13

Drugs

EvaluationDrugModalityDoseRoute
Subject BAF312 Unknown

Indications