Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
TEC-ADHERE
Study on the Dimethyl Fumarate (DMF, Tecfidera®) Persistence of Remitting-relapsing Multiple Sclerosis (RR-MS) Patients Included in the French Patient Support Program (PSP) OroSEP
1 other identifier
observational
353
1 country
63
Brief Summary
The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Typical duration for all trials
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2019
CompletedFirst Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2022
CompletedAugust 1, 2023
July 1, 2023
3.1 years
January 6, 2020
July 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at 6 Months
Persistence is defined as the percentage of participant still being treated by oral DMF at 6 months, according to routine visit.
6 months
Secondary Outcomes (11)
Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at Both 1 Month and 3 Months
1 month and 3 months
Percentage of Participant's with Adherence at 6 Months
6 months
Percentage of Participants by Reason of Oral Dimethyl Fumarate (DMF) Discontinuation at 3 Months and 6 Months
3 month and 6 months
Percentage of Participants with Adverse Events (AEs)
up to 6 months
Percentage of Participants with Adverse Events (AEs) Related to Treatment
up to 6 months
- +6 more secondary outcomes
Study Arms (2)
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).
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).
Interventions
DMF as prescribed as standard of care.
Eligibility Criteria
Study population included participants with RR-MS treated with DMF in clinical practice.
You may qualify if:
- Ability to understand the purpose and risks of the study and giving oral informed consent regarding TEC-ADHERE study and authorization to use protected health information (PHI) in accordance with national and local participant privacy regulations;
- Diagnosis of RR-MS;
- Expanded Disability Status Score (EDSS) under 6.
You may not qualify if:
- Participants with progressive form of Multiple Sclerosis (MS);
- With memory or psychiatric disorders preventing them to complete questionnaires in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (63)
Ch D'Agen
Agen, 47000, France
CH d'Aix-en-Provence
Aix-en-Provence, 13616, France
CHU Amiens
Amiens, 80000, France
CHU D'amiens
Amiens, 80000, France
Cabinet Medical
Angoulême, 16000, France
Cabinet Medical Neurolac
Annecy, 74960, France
CH Antibes
Antibes, 06600, France
Hopital Prive Antony
Antony, 92160, France
CH d'Arras
Arras, 62000, France
CH de Bastia
Bastia, 20600, France
Chic de Bayonne
Bayonne, 64100, France
Cabinet du Dr Imad Malkoun
Belfort, 90000, France
Cabinet des Drs Chanel-Soulier et Cheron
Biarritz, 64200, France
Hôpital Pellegrin / Service : Neurologie
Bordeaux, 33000, France
Polyclinique Bordeaux-Caudéran
Bordeaux, 33200, France
Ch de Carcassonne
Carcassonne, 11000, France
Cabinet des Drs Farhat et Samad
Châtellerault, 86100, France
Chde Cholet
Cholet, 49300, France
HIA Percy
Clamart, 92140, France
Pole de Sante Du Plateau
Clamart, 92140, France
Clinique Des Cedres
Cornebarrieu, 31700, France
Hopital Henri Mondor
Créteil, 94000, France
Ch General Dax
Dax, 40100, France
Cabinet du Dr Pierre Gras
Dijon, 21000, France
CHU Dijon
Dijon, 21000, France
Ch de Douai
Douai, 59500, France
CH Simone Veil d'Eaubonne
Eaubonne, 95600, France
Cabinet de Dr Lotfi Kort
Évreux, 27000, France
Polyclinique des Alpes du Sud
Gap, 05000, France
CHU Grenoble Alpes CS 10217
Grenoble, 38043, France
Cabinet médical
La Rochelle, 17000, France
Pôle Espace Santé 2
La Seyne-sur-Mer, 83500, France
Centre Hospitalier de Libourne
Libourne, 33500, France
Cabinet médical Montebello
Lille, 59000, France
Centre Hospitalier Intercommunal JURA-SUD
Lons-le-Saunier, 39016, France
Chi de Haute Saone
Lure, 70200, France
Cabinet Du Dr Neuschwander
Lyon, 69006, France
Hopital
Melun, 77000, France
CH de Montauban
Montauban, 82000, France
Centre Medical Odysseum
Montpellier, 34000, France
Hopital Gui de Chaulliac
Montpellier, 34090, France
Cabinet des Drs Lorenzi Pernot et Guilloton
Mornant, 69440, France
Clinique d'Occitanie
Muret, 31600, France
Chu Caremeau
Nîmes, 30900, France
CHU Carémeau
Nîmes, 30900, France
Hôpital de la Source
Orléans, 45100, France
Centre Cosem Miromesnil
Paris, 75008, France
Cabinet du Dr Radia Djebbari
Paris, 75011, France
Groupe Hospitalier Paris St Joseph
Paris, 75014, France
Cabinet Médical Monceau
Paris, 75017, France
Cabinet médical
Pau, 64000, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000, France
Chi de Cornouaille
Quimper, 29107, France
Cabinet des Drs Gugenheim et Esna
Rambouillet, 78120, France
Cabinet Du Dr Christophe Robin
Roanne, 42300, France
Hopital Victor Provo
Roubaix, 59100, France
CH de Soissons
Soissons, 02200, France
Cabinet du Dr Annick Gayou-Joyeux
Talence, 33400, France
HIA Sainte Anne
Toulon, 83000, France
Hopital Pierre-Paul Riquet
Toulouse, 31059, France
CHU Bretonneau
Tours, 37000, France
CH de Troyes
Troyes, 10000, France
CH de Valence
Valence, 26000, France
Related Publications (1)
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.
PMID: 39527163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 9, 2020
Study Start
August 19, 2019
Primary Completion
September 14, 2022
Study Completion
September 14, 2022
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/