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

NCT03029897 | Completed

• 1 other identifier: 16-135
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

experimental

EXPERIMENTAL

Patients are educated on the use of a mobile application to report adverse drug reactions

Other: My eReport France

control

NO INTERVENTION

Patients are not educated on the use of a mobile application to report adverse drug reactions

Interventions

My eReport France OTHER

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

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (\> 18 years) with relapsing-remitting multiple sclerosis. Initiation of treatment of 1st line: interferon β, peginterferon β, glatiramer acetate, teriflunomide, dimethyl-fumarate.

You may not qualify if:

• Patient with progressively progressive secondary or multiple sclerosis. Patient suffering from multiple sclerosis not treated with a first line treatment.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen

Caen, 14000, France

Location

Related Publications (2)

• Defer G, Fedrizzi S, Chevanne D, Montastruc F, Briant AR, Parienti JJ, Peyro-Saint-Paul L; French VigipSEP Study Group; Societe Francophone de la Sclerose en Plaques (SFSEP). Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial. Drug Saf. 2021 Feb;44(2):223-233. doi: 10.1007/s40264-020-01009-z. Epub 2020 Oct 13.

  PMID: 33048319 DERIVED

• Defer G, Le Caignec F, Fedrizzi S, Montastruc F, Chevanne D, Parienti JJ, Peyro-Saint-Paul L. Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Trials. 2018 Mar 9;19(1):174. doi: 10.1186/s13063-018-2560-4.

  PMID: 29523169 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: clusters

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: May 5, 2017
• Primary Completion: April 24, 2019
• Study Completion: April 24, 2019
• Last Updated: July 2, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)