E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis (VigiP-SEP)

July 1, 2019 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • CHU Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Actual)

April 24, 2019

Study Completion (Actual)

April 24, 2019

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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