EU Clinical Trial 2018-003008-38

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  May 30, 2019

Main objective of the trial: Part 1- To evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric subjects with RRMS -  To assess the PK of BIIB017 in pediatric subjects with RRMS The primary objective of Part 2 of the study is to evaluate the longterm safety of BIIB017 in subjects who completed the study treatment at Week 96 in Part 1 of the study. Parte 1: - Evaluar la seguridad, la tolerabilidad y eficacia descriptiva de BIIB017 en pacientes pediátricos con EMRR - Evaluar la FC de BIIB017 en pacientes pediátricos con EMRR El objetivo principal de la Parte 2 del estudio es evaluar la seguridad a largo plazo de BIIB017 en pacientes que completaron el tratamiento del estudio en la semana 96 en la parte 1 del estudio.

Parties

Sponsors
Countries
AR AU BE BG BR CZ DE ES EU FR GR HR HU IL IT KW MX PL PT RS RU SA SK TN TR US
Keywords
AVONEX® BIIB017 Interferon Beta-1a Nervous system disorders PEGINTERFERON BETA-1A PEGylated Interferon Beta-1a Plegridy Relapsing-remitting multiple sclerosis interferon beta-1α

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Source:  EMA Last updated:  Jun 5, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.