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Interferon Beta · Frequency

Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy

Ensayo de BIOGEN INC. en Esclerosis multiple recurrente.

Más ensayos de: Esclerosis múltiple recurrente.

Fase

Fase 4

Estado

Retirado antes de empezar

Fin del objetivo primario

feb 2017

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2014.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Due to a change in Biogen Idec's medical research plans.».

Qué mide

Recuentos combinados de acontecimientos adversos (AA) de sintomas pseudogripales, reacciones en el lugar de inyeccion o dolor por reaccion en el lugar de inyeccion (6 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to evaluate, in participants with RMS, safety and tolerability (as defined by the frequency of adverse events \[AEs\] of flu-like symptoms \[FLS; chills, pyrexia, myalgia, and asthenia\], injection site reactions \[ISRs\], and injection site reaction pain \[ISR-P\]) over 6 months of treatment (the active comparator period) with BIIB017 125 μg subcutaneously (SC) every 2 weeks versus standard-of-care SC interferon-beta (IFN-β) therapy. Secondary objectives of this study are to assess the following measures during the first (6-month) period of the study in participants treated with BIIB017 versus standard-of-care SC IFN-β therapy: patient-reported treatment satisfaction using the following patient-reported outcome measures (PROMs): Treatment Satisfaction Questionnaire for Medication (TSQM-9), Adapted MS Treatment Concerns Questionnaire (MSTCQ), Adapted MSTCQ Side Effects Score, Pain using a visual analog scale (VAS) diary and the McGill Pain Questionnaire Short Form (SF-MPQ), the treatments' impact on RMS using the following PROMs: Multiple Sclerosis Impact Scale (MSIS-29), Modified Fatigue Impact Scale-5 Item (MFIS-5), EuroQol Group 5-Dimension 3-Level Version (EQ-5D-3L), Health-Related Productivity Questionnaire (HRPQ), Beck Depression Inventory, second edition (BDI-II), participant adherence to study treatment, clinical status as measured by the Expanded Disability Status Scale (EDSS) and relapse activity, safety and tolerability of study treatment after a change in standard-of-care SC IFN-β therapy and the immunogenicity profiles of participants changing from standard-of-care SC IFN-β to BIIB017.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02234869), actualizada en nov 2014.