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dimethyl fumarate · IMPROVE

Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)

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

Más ensayos de: Esclerosis múltiple remitente-recurrente.

Fase

no aplica

Estado

Interrumpido

Participantes

24

previstos

Centros

10

Fin del objetivo primario

mar 2016

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en may 2015.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns.».

Qué mide

Annualized Relapse Rate (ARR) at month 12 (del registro, en inglés) (mes 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the Prescribing Physician. The secondary objectives of this study in this study population are: To assess the impact of DMF over a 12 month period on patient reported outcomes (PROs) and health economic related outcomes; and to evaluate additional clinical outcomes at Month 12.

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Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02323269), actualizada en abr 2016.