- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03029897
E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis (VigiP-SEP)
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Caen, Frankrig, 14000
- CHU CAEN
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: experimental
Patients are educated on the use of a mobile application to report adverse drug reactions
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patients are educated to the use of "My eReport France" application
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Ingen indgriben: control
Patients are not educated on the use of a mobile application to report adverse drug reactions
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
number of reports of adverse drug reactions
Tidsramme: 6 months
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number of reports of adverse drug reactions per patient in the intervention arm using mobile versus standard arm.
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Kemisk inducerede lidelser
- Patologiske processer
- Sygdomme i nervesystemet
- Sygdomme i immunsystemet
- Demyeliniserende autoimmune sygdomme, CNS
- Autoimmune sygdomme i nervesystemet
- Demyeliniserende sygdomme
- Autoimmune sygdomme
- Multipel sclerose
- Sclerose
- Multipel sklerose, recidiverende-remitterende
- Lægemiddelrelaterede bivirkninger og uønskede reaktioner
Andre undersøgelses-id-numre
- 16-135
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Multipel sclerose
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City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeKlassisk Hodgkin lymfom | Lymfocytrigt klassisk Hodgkin-lymfom | Ann Arbor Stage IB Hodgkin lymfom | Ann Arbor Stage II Hodgkin lymfom | Ann Arbor Stage IIA Hodgkin lymfom | Ann Arbor Stage IIB Hodgkin lymfom | Ann Arbor Stage I Hodgkin lymfom | Ann Arbor Stage I Mixed Cellularity Klassisk Hodgkin-lymfom og andre forholdForenede Stater
Kliniske forsøg med My eReport France
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...Afsluttet
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University of MichiganThe Craig H. Neilsen FoundationRekrutteringAccept- og forpligtelsesterapi for kronisk smerte ved SCI: Udvikling og test af et e-sundhedsprogramRygmarvsskaderForenede Stater
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University of Turin, ItalyAfsluttetKognitiv svækkelse | Skrøbelige ældres syndrom | Fysisk afhængighedItalien
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University of Colorado, DenverUniversity of Southern California; Colorado State University; Clemson UniversityAfsluttetKronisk sygdomForenede Stater
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Aarhus University HospitalRekrutteringVedvarende fysiske symptomerDanmark
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The University of Texas Health Science Center,...National Institute of Nursing Research (NINR)Ikke rekrutterer endnu
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Washington University School of MedicineAktiv, ikke rekrutterende
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H. Lee Moffitt Cancer Center and Research InstituteAfsluttetGI-kræft | Ernæringsmæssig mangelForenede Stater
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Virginia Polytechnic Institute and State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbejdspartnereAfsluttet
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Shenandoah UniversityAfsluttet