Active Dermatomyositis
Conditions
Interventions
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 Investigation
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| incidence of adverse events plasma BAF312 concentrations. peripheral blood lymphocyte counts Changes from baseline in MMT-24 at 3 months | — |
Outcome results
None listed