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EFFECT

Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)

Ensayo de BIOGEN INC. en Esclerosis multiple.

Más ensayos de: Esclerosis múltiple.

Fase

no aplica

Estado

Completado

Participantes

2.978

previstos

Centros

121

Fin del objetivo primario

dic 2016

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en may 2016.

Qué mide

Proportion of participants relapsed at 12 months in participants treated with DMF (One day) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF). Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02776072), actualizada en mar 2017.