CTRI/2021/12/038986Other3 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. - NA
Biogen MA Inc Biogen Idec Research Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
- •2 Must have an EDSS score between 0.0 and 5.0.
- •3 Must have a body weight of ââ?°Â¥30 kg
- •4 Must have experienced ââ?°Â¥1 relapse in the 12 months prior to randomization (Day 1) or must have evidence of asymptomatic disease activity seen on MRI in the 6 months prior to randomization, or ââ?°Â¥2 relapses in the 24 months prior to randomization (Day 1). Relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event
排除标准
- •1 Participants having primary progressive, secondary progressive, or progressive RMS.
- •2 Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders.
- •3 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
- •4 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 Inclusion/Exclusion criteria may apply.
研究者
相似试验
进行中（未招募）
不适用
A 12-Week Study of Two Doses of Beclomethasone Dipropionate Delivered through Two Different Types of Inhalers in Children 4-11 Years of Age with Persistent AsthmaPersistent AsthmaEUCTR2013-004632-30-HRTeva Branded Pharmaceutical Products R&D, Inc.600
进行中（未招募）
1 期
Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric ParticipantsRelapsing Remitting Multiple Sclerosis (RRMS)MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disordersEUCTR2018-000516-22-HUBiogen Idec Research Limited340
进行中（未招募）
不适用
A 12-Week Study of Two Doses of Beclomethasone Dipropionate Delivered through Two Different Types of Inhalers in Children 4-11 Years of Age with Persistent AsthmaPersistent AsthmaEUCTR2013-004632-30-PLTeva Branded Pharmaceutical Products R&D, Inc.600
进行中（未招募）
1 期
Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric ParticipantsEUCTR2018-000516-22-PTBiogen Idec Research Limited340
进行中（未招募）
不适用
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Treatment, Three 6-Week Period Cross-Over, Multi-Center Exploratory Study to Evaluate the Effect of Adding GSK2190915 300mg Tablets Once Daily, Montelukast 10mg Tablets Once Daily or Placebo Tablets Once Daily to Fluticasone Propionate 250mcg/Salmeterol 50mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects > 18 Years of Age.AsthmaEUCTR2010-019989-91-BGGlaxoSmithKline Research & Development Ltd120