An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple 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3月29日最近更新: 2019年11月25日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Biogen Idec Research Limited
入组人数: 142

研究概览入排标准研究者记录与标识符相似试验

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

•1. Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parent’s or guardian’s consent, as appropriate, per local regulations.
•2. Age 10 to <18 years old at the time of informed consent. The minimum age can be older than 10 years, as required by country-specific regulations and/or local ethics committees.
•3. Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS [Krupp 2013; Polman 2011].
•4. Must have an EDSS score between 0.0 and 5.5.
•5. 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). Relapse is defined as the occurrence of a clinical
•demyelination event regardless of whether the event is a first (initial) or subsequent (recurrent) demyelinating event.
•6. Female subjects of childbearing potential and all male subjects must practice effective contraception during the study and for 3 months after their last dose of study treatment, unless they agree to abstinence. For further details of contraceptive requirements for this
•study, see Section 15.5.
•1. Subjects who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.
•2. Sexually active subjects of childbearing potential must continue to practice effective contraception during the study and for 3 months after their last dose of study treatment.
•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

排除标准

•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. History of seizure disorder or unexplained blackouts, or history of a seizure within 3 months prior to randomization (Day 1).
•3. History of suicidal ideation within 3 months prior to randomization (Day 1) or an episode of severe depression within 3 months prior to randomization (Day 1). Severe depression is defined as an episode of depression that requires hospitalization or is otherwise regarded as severe by the Investigator.
•4. 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).
•5. History of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator that would preclude participation in the study.
•6. Abnormal screening blood tests exceeding any of the following defined limits:
•a. ALT >2 upper limit of normal (ULN)
•b. AST >2 ULN
•c. Gamma-glutamyl transferase (GGT) >2 ULN
•d. Total bilirubin >1.5 ULN
•e. Total WBC count <3700/mm3
•ANC ?1500/mm3
•f. Platelet count <150,000/mm3
•g. Hemoglobin <10 g/dL in female subjects or <11 g/dL in male subjects
•h. Serum creatinine >1 ULN
•i. Prothrombin time or activated partial thromboplastin time >1.2 ULN
•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.

研究者

发起方

Biogen Idec Research Limited

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