Relapsing-Remitting Multiple Sclerosis Clinical Trial
Official title:
An Open- Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017
The primary objective of this study is to determine the proportion of relapsing multiple
sclerosis (RMS) participants who experience new and/or increased flu-like symptoms (FLS)
after transitioning from nonpegylated interferon beta (IFN-β) therapies to peginterferon
beta-1a (BIIB017).
Secondary objectives are: To determine the severity and frequency (measured by flu-like
symptom score [FLS-S]) of FLS in these participants; To determine the duration (measured in
number of hours) of FLS in these participants; To determine the effectiveness and
participants' satisfaction with FLS management as measured by an FLS visual analog scale
(FLS-VAS); To determine the effect of peginterferon beta-1a on other participant reported
outcomes (PROs) including treatment satisfaction (measured with the Treatment Satisfaction
Questionnaire for Medication [TSQM]) and disability status (measured with the Patient
Determined Disease Steps [PDDS]) over a 56-week period; To determine whether
interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism);
To assess the use of additional medications (in addition to current medications used to
treat FLS) to relieve peginterferon beta-1a -related FLS; to determine the incidence of
adverse events (AEs) throughout the study period; to characterize the immunogenicity
profiles of participants switching from prior IFN-β (interferon beta) therapy to
peginterferon beta-1a.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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