EUCTR2012-002859-42-CZ进行中（未招募）1 期
A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- •-definite or probable for polymyositis at least three months before Baseline
- •- active active myositis as defined by elevated CK levels, or other enzymes, or MRI/biopsy if enzymes are normal, and persisting muscle weakness
- •- stable dose of corticosteroid for at least 2 weeks prior to Baseline and should not have received a high dose in the last 8 weeks prior to study entry.
- •- patients treated with methotrexate must have been on a stable dose for at least 6 weeks prior to Baseline.
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •- Patients with overlap polymyositis, late-stage polymyositis, or other types of myositis.
- •- Preexisting severe cardiac or pulmonary involvement, 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 may apply.
研究者
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