Study of efficacy and tolerability for BAF312 compared to placebo in patients with active dermatomyositis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 56

Inclusion Criteria

• Written informed consent must be obtained before any assessment is performed.
• Male and female patients between 18 - 65 (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 least 12 months before screening
• Patients must have active disease as defined by dermatomyositis skin rash AND Muscle weakness
• Patients must have responded inadequately to previous standard of care or have demonstrated significant toxicity or intolerance to such therapies.
• 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 MTX 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 6 months prior to screening visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

• Dermatomyositis patients having overlap myositis or any other type of myositis including paraneoplastic myositis, drug-induced myopathy, necrotizing myositis
• Preexisting severe cardiac or pulmonary conditions, malignancy of any organ system or significant eye diseases.
• Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.
• Pregnant or nursing (lactating) women
• Other protocol-defined inclusion/exclusion criteria apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of different doses of BAF312 on the MMT-8 after 6 months of treatment.;Secondary Objective: To assess the effects of different doses of BAF312 on safety, pharmacokinetics and peripheral blood lymphocyte counts in active DM patients<br><br>To assess the efficacy of different doses of BAF312 after 3 months of treatment in active DM patients as assessed by manual muscle testing using the MMT-8 scoring system;Primary end point(s): To assess the efficacy of different doses of BAF312 after 6 months of treatment in active DM patients as assessed by manual muscle testing using the MMT-8 scoring system.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - To assess the effects of different doses of BAF312 on safety, pharmacokinetics and peripheral blood lymphocyte counts in active DM patients.<br>- To assess the efficacy of different doses of BAF312 after 3 months of treatment in active DM patients as assessed by manual muscle testing using the MMT-8 scoring system.;Timepoint(s) of evaluation of this end point: - for the first listed secondary endpoint : at every visit (after 10 days followed by every month for 1 year)<br>- for the second listed secondary endpoint: at 3 months

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