Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate (SURV-SEP)
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|ClinicalTrials.gov Identifier: NCT02901106|
Recruitment Status : Terminated (Another surveillance protocol was initiated by the OFSEP (OFSEP cohort) which allows to follow all the patients, whatever their treatment.)
First Posted : September 15, 2016
Last Update Posted : January 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-Remitting||Drug: Dimethyl fumarate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP|
|Actual Study Start Date :||May 23, 2017|
|Actual Primary Completion Date :||October 17, 2017|
|Actual Study Completion Date :||October 17, 2017|
|Experimental: Patient with recurring-remitting MS||
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
- Number of patients with a relapse and/or progressive worsening of disease (EDSS score) [ Time Frame: After one year of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901106
|Fondation Ophtalmique Adolphe de Rothschild|
|Paris, France, 75019|