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

Multiple Sclerosis Clinical Trial

— VigiP-SEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029897
• Other study ID #: 16-135
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: April 24, 2019

Study information

• Verified date: April 2018
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: April 24, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patient (> 18 years) with relapsing-remitting multiple sclerosis. Initiation of treatment of 1st line: interferon ß, peginterferon ß, 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.

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Other:
• My eReport France
patients are educated to the use of "My eReport France" application

Locations

Country	Name	City	State
France	CHU Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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