EUCTR2018-000516-22-HU进行中（未招募）1 期
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
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
入选标准
- •Key inclusion criteria: Must have a diagnosis of RRMS as defined by the
- •revised consensus definition for pediatric MS
- •Must have an EDSS score between 0.0 and 5.0.
- •Must have a body weight of =30 kg
- •Must have experienced =1 relapse in the 12
- •months prior to randomization (Day 1) or =2 relapses in
- •the 24 months prior to randomization (Day 1).
- •Note: Other protocol inclusion criteria may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 340
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key Exclusion Criteria: Participants having primary progressive, secondary
- •progressive, or progressive RMS.
- •Disorders mimicking MS, such as other
- •demyelinating disorders, systemic autoimmune
- •disorders, metabolic disorders, and infectious disorders.
- •History of clinically significant cardiovascular,
- •pulmonary, GI, hepatic, renal, endocrinologic,
- •hematologic, immunologic, metabolic, dermatologic,
- •growth, developmental, psychiatric (including
- •depression), neurologic (other than MS), and/or other
- •major disease
- •and/or laboratory abnormality indicative thereof,
- •that would preclude participation in a clinical study
- •Occurrence of an MS relapse within the 30 days
- •prior to randomization (Day 1) and/or the subject has not
- •stabilized from a previous relapse prior to randomization
- •Note: other protocol defined Exclusion criteria may apply
研究者
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