RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Rebif®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117050

EMR200136-586

Details and patient eligibility

About

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™.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Rebif® via Rebidose® auto-injector

Experimental group

Treatment:

Drug: Rebif®