EUCTR2013-001799-39-BE进行中（未招募）1 期
A double blind, randomized, placebo-controlled study to evaluate, safety, tolerability, efficacy and preliminary dose-response of BAF312 in patients with active dermatomyositis. - safety and efficacy of BAF312 in dermatomyositis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent must be obtained before any assessment is
- •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
排除标准
- •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.
研究者
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