Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT02901106
Status:
TERMINATED
Last Update Posted:
2019-01-09
First Post:
2016-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Study Overview
Official Title:
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Another surveillance protocol was initiated by the OFSEP (OFSEP cohort) which allows to follow all the patients, whatever their treatment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURV-SEP
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: