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

NCT02901106 | Terminated Phase 4

• 1 other identifier: JAB_2016_17
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Relapsing-Remitting; Dimethyl fumarate

Outcome Measures

Primary Outcomes (1)

• Number of patients with a relapse and/or progressive worsening of disease (EDSS score)

  After one year of treatment

Study Arms (1)

Patient with recurring-remitting MS

EXPERIMENTAL

Drug: Dimethyl fumarate

Interventions

Dimethyl fumarate 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

Patient with recurring-remitting MS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 15, 2016
• Study Start: May 23, 2017
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

FR (1)