Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2017-10-17

Brief Summary

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The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.

Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease.

It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment.

The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

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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Patient with recurring-remitting MS

Group Type EXPERIMENTAL

Dimethyl fumarate

Intervention Type DRUG

Patient follow-up at 6, 12, 18, 36, and 60 months after the start of Dimethyl fumarate

Systematization of cerebral MRI examination at 18 month and 5 years from the beginning of treatment by Dimethyl fumarate

Interventions

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Dimethyl fumarate

Patient follow-up at 6, 12, 18, 36, and 60 months after the start of Dimethyl fumarate

Systematization of cerebral MRI examination at 18 month and 5 years from the beginning of treatment by Dimethyl fumarate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patient 18 years old and more
* with multiple sclerosis according to the criteria of Mac Donald 2010 : relapsing-remitting (RR), secondary-progressive (SP) or primary-progressive (PP)
* for which treatment with dimethyl-fumarate has been prescribed
* followed at the Rothschild Foundation in the Neurology Department
* having given written consent to participation in the study