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BIIB019 · EXTEND

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019

Ensayo de BIOGEN INC. en Esclerosis multiple remitente-recurrente · Esclerosis multiple.

Más ensayos de: Esclerosis múltiple remitente-recurrente · Esclerosis múltiple.

Fase

Fase 3

Estado

Interrumpido

Participantes

1.501

previstos

Centros

222

Fin del objetivo primario

sep 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en feb 2013.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study terminated because of differences in the participant population under study compared with indicated Zinbryta use in most countries.».

Qué mide

Numero de participantes con acontecimientos adversos (AA) y acontecimientos adversos graves (AAG) (First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). Secondary objectives of this study in this study population are as follows: To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01797965), actualizada en nov 2019.