Safety and Efficacy of BAF312 in Dermatomyositis

Summary

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 .

Timeline

Start

2013-08-25

Primary completion

2016-02-17

Completion

2016-02-17

Drugs

Indications