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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— SURV-SEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02901106
• Other study ID #: JAB_2016_17
• Status: Terminated
• Phase: Phase 4
• Start date: May 23, 2017
• Est. completion date: October 17, 2017

Study information

• Verified date: January 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	Fondation Ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a relapse and/or progressive worsening of disease (EDSS score)		After one year of treatment