Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

• Status: Terminated
• Trial end date: 2012-06-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Siponimod

Criteria

Inclusion Criteria:

• Patients with disease at least 3 months before study

• Muscle weakness

• Received corticosteroids with or with out disease modifying antirheumatic drugs at least 3 months before study however not responding to this therapy

Exclusion Criteria:

• Other idiopathic inflammatory myopathies

• Myopathy other than polymyositis and dermatomyositis

• Patients with late stages of disease