Safety and Efficacy of BAF312 in Dermatomyositis

Trial ID or NCT#

NCT02029274

Status

not recruiting iconNOT RECRUITING

Purpose

This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .

Official Title

A Double Blind, Randomized, Placebo-controlled Study to Evaluate, Safety, Tolerability, Efficacy and Preliminary Dose-response of BAF312 in Patients With Active Dermatomyositis (DM)

Eligibility Criteria

Ages Eligible for Study: 18 to 75
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Written informed consent must be obtained before any assessment is performed.
    1. * 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
  2. Key Exclusion Criteria
    1. * 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
Exclusion Criteria:
  1. * 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
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