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.
• Patients who have been defined as definite or probable based on
the criteria of Bohan and Peter (Bohan and Peter 1975) for
dermatomyositis at least 3 months before screening
• Patients must have active disease as defined by 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 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 12 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: The primary aim of this study is to assess the efficacy of different doses<br>of BAF312 on the MMT-24 after 6 months. The overall efficacy of BAF312<br>will be assessed by comparing the improvements of MMT-24 with every<br>dose of BAF312 to that of placebo. Then the dose response curve of<br>MMT-24 will be estimated with the aim to determine a target dose for<br>the program.;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): Manual Muscle Testing - 24 muscles (MMT-24). Efficacy of BAF312 will<br>be assessed by comparing the improvements with every dose of BAF312<br>to that of placebo;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method

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