Safety and Efficacy of BAF312 in Dermatomyositis.
- Conditions
- Active Dermatomyositis
- Registration Number
- JPRN-jRCT2080222539
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 56
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method incidence of adverse events<br><br>plasma BAF312 concentrations.<br><br>peripheral blood lymphocyte counts<br><br>Changes from baseline in MMT-24 at 3 months