This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS). Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks. The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
Study Type
OBSERVATIONAL
Enrollment
198
Electronic self-injection device (RebiSmart™) to inject Rebif®
Electronic self-injection device (RebiSmart™) to inject Rebif®
University of British Columbia
Vancouver, Canada
Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
Time frame: 24 weeks
Long-term adherence in subjects with RMS over 96 weeks of treatment using RebiSmart for self-injection of Rebif® in multi-dose cartridge.
Time frame: 96 weeks
Treatment persistence by measuring treatment discontinuations
Time frame: 96 weeks
Treatment compliance
Measuring the number of injections received relative to the time on study
Time frame: 96 weeks
Comparison of subject treatment adherence between categories of cognitive function
Measured by the short version of Rao's Brief Repeatable Battery (BRB)
Time frame: 96 weeks
Longitudinal changes in anxiety symptoms
Measured by the Hospital Anxiety and Depression Scale (HAD) and State-Trait Anxiety Inventory (STAI)
Time frame: 96 weeks
Qualitative assessment of subjects' experience with RebiSmart
A standardized Patient Experience Questionnaire (PEQ) will be used for the assessment.
Time frame: 96 weeks
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