RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-04-30

Brief Summary

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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™.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rebif® via Rebidose® auto-injector

Group Type EXPERIMENTAL

Rebif®

Intervention Type DRUG

Rebif® will be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.

Interventions

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Rebif®

Rebif® will be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.

Intervention Type DRUG

Other Intervention Names

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interferon-beta-1a

Eligibility Criteria

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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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No