RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate



Status:Recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 65
Updated:7/11/2015
Start Date:June 2014
End Date:January 2017
Contact:EMD Serono Medical Information
Phone:888-275-7376

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Trial Summary
Trial Overview
Inclusion Criteria

RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw)

This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment
satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently
being treated with, but are considering discontinuing treatment with Tecfidera™.


Key inclusion Criteria:

- Diagnosis of relapsing form of MS

- Have declared a desire/plan to discontinue treatment with Tecfidera due to
tolerability issues and/or lack of efficacy

- Expanded Disability Status Scale (EDSS) score 0 to 5.0 inclusive

- Other protocol defined inclusion criteria could apply

Key exclusion Criteria:

- Pregnant or lactating

- Significant renal or hepatic impairment or other significant disease that would
compromise adherence and completion of the trial

- Other protocol defined exclusion criteria could apply
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