E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: My eReport France


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: clusters
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>Patients are educated on the use of a mobile application to report adverse drug reactions | Other: My eReport France<br>* patients are educated to the use of My eReport France application<br>|
| No Intervention: control<br>Patients are not educated on the use of a mobile application to report adverse drug reactions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of reports of adverse drug reactions | number of reports of adverse drug reactions per patient in the intervention arm using mobile versus standard arm. | 6 months |