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Safety and Efficacy of BAF312 in Dermatomyositis

Novartis Pharmaceuticals · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .
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