An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension

Biogen Idec Research Limited0 个研究点目标入组 142 人开始时间: 2019年4月26日最近更新: 2024年3月12日

适应症

试验速览

暂无简介。

•1. Must have a diagnosis of RRMS as defined by the revised consensus definition for
•pediatric MS [Krupp 2013; Polman 2011].
•2. Must have an EDSS score between 0.0 and 5.5.
•3. 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) or have evidence of
•asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior
•to randomization (Day 1).
•Subjects who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 142
•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

•1. Primary progressive, secondary progressive, or progressive relapsing MS .These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing subjects by the lack of clinically stable periods or clinical improvement.
•2. Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization (Day 1).
•3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
•4. Known allergy to any component of Avonex or BIIB017 formulation.
•5. Any previous treatment with PEGylated human IFN ß-1a.
•1. Any significant changes in medical history occurring after enrollment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the subject’s participation in Part 1.
•The Investigator must re-assess the subject’s medical fitness for participation and consider any factors that would preclude treatment.
•2. The subject could not tolerate BIIB017 in Part 1.
•NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

发起方