RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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™.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Treatments: Dimethyl Fumarate; Interferon beta-1a; Interferon-beta; Interferons

Criteria

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