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

Phase 4

Terminated

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Dimethyl fumarate

• Registration Number: NCT02901106
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-15
• Study Start: 2017-05-23
• Primary Completion: 2017-10-17
• Study Completion: 2017-10-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Exclusion Criteria

• pregnant or breastfeeding woman
• patient with a measure of legal protection
• subject unaffiliated insurance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with recurring-remitting MS	Dimethyl fumarate	-

Primary Outcome Measures

Name	Time	Method
Number of patients with a relapse and/or progressive worsening of disease (EDSS score)	After one year of treatment

Trial Locations

Locations (1)

Fondation Ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France