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