Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy
Status:
Withdrawn
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
The 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.