Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
NCT ID: NCT04221191
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
353 participants
OBSERVATIONAL
2019-08-19
2022-09-14
Brief Summary
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The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively;
For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Standard of Care (SoC) Group
SoC neurologists will include and follow-up all study participants who receive DMF according to their standard of care practice (non-coached participants).
Dimethyl Fumarate
DMF as prescribed as standard of care.
OroSEP PSP (OPSP) Group
OPSP neurologists will include and follow-up all study participants who receive DMF according to their standard of care practice and the OroSEP PSP (coached participants).
Dimethyl Fumarate
DMF as prescribed as standard of care.
PSP
PSPs is to support patient care.
Interventions
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Dimethyl Fumarate
DMF as prescribed as standard of care.
PSP
PSPs is to support patient care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of RR-MS;
* Initiating oral DMF according to Summary of Product Characteristics (SmPC) at the inclusion visit;
* Expanded Disability Status Score (EDSS) under 6.
Exclusion Criteria
* With memory or psychiatric disorders preventing them to complete questionnaires in the study.
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Ch D'Agen
Agen, , France
CH d'Aix-en-Provence
Aix-en-Provence, , France
CHU Amiens
Amiens, , France
CHU D'amiens
Amiens, , France
Cabinet Medical
Angoulême, , France
Cabinet Medical Neurolac
Annecy, , France
CH Antibes
Antibes, , France
Hopital Prive Antony
Antony, , France
CH d'Arras
Arras, , France
CH de Bastia
Bastia, , France
Chic de Bayonne
Bayonne, , France
Cabinet du Dr Imad Malkoun
Belfort, , France
Cabinet des Drs Chanel-Soulier et Cheron
Biarritz, , France
Hôpital Pellegrin / Service : Neurologie
Bordeaux, , France
Polyclinique Bordeaux-Caudéran
Bordeaux, , France
Ch de Carcassonne
Carcassonne, , France
Cabinet des Drs Farhat et Samad
Châtellerault, , France
Chde Cholet
Cholet, , France
HIA Percy
Clamart, , France
Pole de Sante Du Plateau
Clamart, , France
Clinique Des Cedres
Cornebarrieu, , France
Hopital Henri Mondor
Créteil, , France
Ch General Dax
Dax, , France
Cabinet du Dr Pierre Gras
Dijon, , France
CHU Dijon
Dijon, , France
Ch de Douai
Douai, , France
CH Simone Veil d'Eaubonne
Eaubonne, , France
Cabinet de Dr Lotfi Kort
Évreux, , France
Polyclinique des Alpes du Sud
Gap, , France
CHU Grenoble Alpes CS 10217
Grenoble, , France
Cabinet médical
La Rochelle, , France
Pôle Espace Santé 2
La Seyne-sur-Mer, , France
Centre Hospitalier de Libourne
Libourne, , France
Cabinet médical Montebello
Lille, , France
Centre Hospitalier Intercommunal JURA-SUD
Lons-le-Saunier, , France
Chi de Haute Saone
Lure, , France
Cabinet Du Dr Neuschwander
Lyon, , France
Hopital
Melun, , France
CH de Montauban
Montauban, , France
Centre Medical Odysseum
Montpellier, , France
Hopital Gui de Chaulliac
Montpellier, , France
Cabinet des Drs Lorenzi Pernot et Guilloton
Mornant, , France
Clinique d'Occitanie
Muret, , France
Chu Caremeau
Nîmes, , France
CHU Carémeau
Nîmes, , France
Hôpital de la Source
Orléans, , France
Centre Cosem Miromesnil
Paris, , France
Cabinet du Dr Radia Djebbari
Paris, , France
Groupe Hospitalier Paris St Joseph
Paris, , France
Cabinet Médical Monceau
Paris, , France
Cabinet médical
Pau, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Chi de Cornouaille
Quimper, , France
Cabinet des Drs Gugenheim et Esna
Rambouillet, , France
Cabinet Du Dr Christophe Robin
Roanne, , France
Hopital Victor Provo
Roubaix, , France
CH de Soissons
Soissons, , France
Cabinet du Dr Annick Gayou-Joyeux
Talence, , France
HIA Sainte Anne
Toulon, , France
Hopital Pierre-Paul Riquet
Toulouse, , France
CHU Bretonneau
Tours, , France
CH de Troyes
Troyes, , France
CH de Valence
Valence, , France
Countries
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References
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Labauge P, Creange A, Moreau T, Nouvet-Gire J, Pedespan B, Heinzlef O, Texier N, Gros M, Marti C, Ruiz M, Martinez M, Castelnovo G. TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program. Neurol Ther. 2025 Feb;14(1):177-192. doi: 10.1007/s40120-024-00674-x. Epub 2024 Nov 11.
Other Identifiers
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FRA-BGT-18-11469
Identifier Type: -
Identifier Source: org_study_id
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