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dimethyl fumarate · ESTEEM

Dimethyl Fumarate (DMF) Observational Study

Ensayo de BIOGEN INC. en Esclerosis multiple.

Más ensayos de: Esclerosis múltiple.

Fase

no aplica

Estado

Completado

Participantes

5.487

previstos

Centros

468

Fin del objetivo primario

oct 2022

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en nov 2013.

Qué mide

The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF) (del registro, en inglés) (hasta 5 años)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02047097), actualizada en may 2023.