Multiple Sclerosis Clinical Trial
Official title:
VIGIP-SEP2: Evaluation of the Impact of the Training of Patients by a Nurse on the Adverse Drug Reaction Reporting by RRMS Patient Via a Mobile Application: Randomized Real-life Study
The patient's reporting of adverse drug reactions (ADRs) is recognized as being of interest
for post-marketing safety monitoring, but is still underdeveloped in France, with an average
lower than the European average. A multidisciplinary team of the University Hospital of Caen,
composed of neurologists and pharmacovigilants, has been carrying out since autumn 2017 a
national study (VIGIP-SEP1) with 24 research centers in France (12 universitary hospitals, 6
general hospitals, and 6 private-practice neurologists) whose main objective was to evaluate
the impact of multiple sclerosis (MS) patients' use of a mobile application (App) to report
their ADRs. My eReport France® has been developed by the eVedrug company: ADR reports are
sent by patients directly to the Regional Pharmacovigilance Centers, after analyze, clinical
pharmacologist send it to the National Competent Authority. As part of VIGIP-SEP1, the
accompaniment for the use of the App was carried out very simply by neurologists.
We designed a randomized controlled trial based on the assumption that a nurse training of
the patient, after the initial prescription of an oral MS drug, with a telephone follow-up
within 6 months, will increase by 3 times the number of patients who report ADRs compared to
a simple information presented by the neurologist. The number of subjects required is 23
subjects per group.
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