Status: Finalised First registered on: 20/11/2017
Last updated on: 24/11/2022
1. Study identification
EU PAS Register NumberEUPAS21563
Official titleEffectiveness of Tecfidera® in multiple sclerosis: a French cohort within the nationwide claims and hospital database
Study title acronymEVIDEMS
Study typeOther: Study using the SNIIRAM claims and hospitalisation database
Brief description of the studyMultiple sclerosis (MS) is an incapacitating, progressive, chronic neurological disorder that involves a selective, chronic inflammation and demyelination of the central nervous system. The severity of the disease varies from mildly forms to severe disabilities within a few years. Relapsing-remitting MS forms (RRMS) are the most common, and are characterized by the presence of relapses without disability progression between relapses. The aim of the disease modifying therapy is to reduce the frequency of relapses and to slow the disability progression. The first-line long-term treatments for RRMS were interferon beta-1a and 1b and glatiramer acetate, while Natalizumab and fingolimod have a Marketing Authorisation restricted to highly active RRMS. Two other oral drugs were approved recently for the treatment of adult patients with MS: teriflunomide marketed since November 2014 and Dimethyl fumarate prescribed within a hospital compassionate use program since March 2014, and officially reimbursed 25 June 2015 for prescription to outpatients. In the context of the renewal of the registration of Tecfidera® in 2020, this project was designed to assess the drug usage pattern in MS after Tecfidera® launch in France, and to compare the benefit of Tecfidera® to other drugs in current practice, and especially to the two other oral drugs, Aubagio® and Gilenya®, using the SNIIRAM nationwide claims and hospital database.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Blin
First name Patrick
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/11/2015
Start date of data collection01/12/201730/11/2017
Start date of data analysis31/01/201831/03/2018
Date of interim report, if expected
Date of final study report31/03/202020/04/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBiogen France SAS100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1146 Rue Leo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address patrick.blin@u-bordeaux.fr
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address patrick.blin@u-bordeaux.fr 
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