Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate (SURV-SEP)
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Dimethyl fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple Sclerosis, Relapsing-Remitting, Dimethyl fumarate
Eligibility 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
Sites / Locations
- Fondation Ophtalmique Adolphe de Rothschild
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with recurring-remitting MS
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with a relapse and/or progressive worsening of disease (EDSS score)
Secondary Outcome Measures
Full Information
NCT ID
NCT02901106
First Posted
September 7, 2016
Last Updated
January 7, 2019
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02901106
Brief Title
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate
Acronym
SURV-SEP
Official Title
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Another surveillance protocol was initiated by the OFSEP (OFSEP cohort) which allows to follow all the patients, whatever their treatment.
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
October 17, 2017 (Actual)
Study Completion Date
October 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple Sclerosis, Relapsing-Remitting, Dimethyl fumarate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with recurring-remitting MS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dimethyl fumarate
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of patients with a relapse and/or progressive worsening of disease (EDSS score)
Time Frame
After one year of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Fondation Ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate
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