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

NCT02901106 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-01-09

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

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

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2017-10-17
Completion
2017-10-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02901106 on ClinicalTrials.gov