E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis
E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis
Adverse drug reactions are collected exhaustively during the experimental development phase
 of the drug, but the trial population is not representative. In post-marketing authorization,
 the use in the real life of medicines requires to specify the profile of adverse effects
 through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug
 reactions prevents a satisfactory knowledge of the risks. For example, in the multiple
 sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported
 by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera®
 dimethyl-fumarate, while trials reported 39% of flush.

 The investigators propose a study measuring the impact of the deployment of e-reporting to
 patients in a population suffering from multiple sclerosis in initiation of first line drug
 therapy. The study design will be a randomized controlled trial. Twenty-four direct or
 indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without
 intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal
 neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5
 patients, a total of 180 patients will be included. The expected duration of this study is 12
 months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient.
 At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be
 made by telephone call to each patient.

 The study is part of the pharmacovigilance system in place in France and aims to improve its
 efficiency by increasing declarations and therefore earlier detection of signals in order to
 prevent and minimize risks.

 The comparison of the two arms should make it possible to decide on the usefulness of
 national support for e-reporting, while respecting a good integration with the French
 pharmacovigilance system.
Inclusion Criteria:

 Patient (> 18 years) with relapsing-remitting multiple sclerosis. Initiation of treatment
 of 1st line: interferon β, peginterferon β, glatiramer acetate, teriflunomide,
 dimethyl-fumarate.

 Exclusion Criteria:

 Patient with progressively progressive secondary or multiple sclerosis. Patient suffering
 from multiple sclerosis not treated with a first line treatment.