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peginterferon beta-1a · POP

Plegridy Observational Program

Ensayo de BIOGEN INC. en Relapsing Forms of Multiple Sclerosis (del registro, en inglés).

Fase

no aplica

Estado

Completado

Participantes

1.208

previstos

Centros

152

Fin del objetivo primario

ene 2022

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en nov 2014.

Qué mide

Safety as measured by the incidence proportion of SAEs (del registro, en inglés) (hasta 5 años)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

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Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02230969), actualizada en sep 2022.