Effectiveness of Tecfidera® in multiple sclerosis: a French cohort within the nationwide claims and hospital database (EVIDEMS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49938
• EU PAS number:
  EUPAS21563
• Study ID:
  49938
• Official title and acronym:
  Effectiveness of Tecfidera® in multiple sclerosis: a French cohort within the nationwide claims and hospital database (EVIDEMS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Multiple 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 20/11/2015

Study start date

Planned: 01/12/2017

Actual: 30/11/2017

Data analysis start date

Planned: 31/01/2018

Actual: 31/03/2018

Date of final study report

Planned: 31/03/2020

Actual: 20/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen France SAS

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable