Source: https://ironsift.com/record/display/EU-clinical-trial-2018-003008-38
Timestamp: 2019-08-24 13:20:24
Document Index: 327670569

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'arte 1', 'arte 2', 'arte 1']

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 - Ironsift
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.
Biogen Idec Research Limited Biogen Idec Research Limited
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
AVONEX® BIIB017 Interferon Beta-1a Nervous system disorders PEGINTERFERON BETA-1A PEGylated Interferon Beta-1a Plegridy Relapsing-remitting multiple sclerosis interferon beta-1α
Full record for 2018-003008-38/ES on ClinicalTrialsRegister.eu
Full record for 2018-003008-38/HU on ClinicalTrialsRegister.eu
The original record can be accessed at https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003008-38/ES, https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003008-38/HU.