Safety and Efficacy of BAF312 in Dermatomyositis.

INTERVENTION: investigational material(s) Generic name etc : BAF312 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : BAF312 0.5 mg once daily, BAF312 2 mg once daily, BAF312 10 mg once daily, Placebo once daily control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Oral administrated once a day CONDITION: Active Dermatomyositis PRIMARY OUTCOME: Manual Muscle Testing ‐24 muscles (MMT‐24). Efficacy of BAF312 will be assessed by comparing the improvements with every dose of BAF312 to that of placebo. [ Time Frame: 6 months ] SECONDARY OUTCOME: incidence of adverse events; ; plasma BAF312 concentrations.; ; peripheral blood lymphocyte counts; ; Changes from baseline in MMT‐24 at 3 months INCLUSION CRITERIA: ‐Male and female patients between 18 ‐ 75 (inclusive) years of age who have been defined as "definite" or "probable" based on the criteria of Bohan and Peter (Bohan and Peter 1975) for dermatomyositis at leas 3 months before screening ‐Patients must have active disease as defined by dermatomyositis muscle weakness ‐Patients may be on a stable dose of corticosteroid (up/equal to 20 mg once daily prednisone equivalent) ‐Patients currently treated with oral or subcutaneous Methotrexate must have been a stable dose of no more/equal to than 25 mg per week ‐Patients currently treated with Azathioprine must have been a stable maintenance dose of no more/equal to 3 mg/kg/day ‐Negative cancer screening conducted in the 12 months prior to screening visit