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

• Status: Terminated
• Trial end date: 2017-10-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Treatments: Dimethyl Fumarate

Criteria

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