Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
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This study will determine the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients that are not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study will consist of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects will receive BAF312 treatment.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with disease at least 3 months before study
Received corticosteroids with or with out disease modifying antirheumatic drugs at least 3 months before study however not responding to this therapy
Other idiopathic inflammatory myopathies
Myopathy other than polymyositis and dermatomyositis
Patients with late stages of disease Other protocol-defined inclusion/exclusion criteria may apply