Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

A Multi-centre, Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

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.

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