Clinical trial NCT04221191: Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population included participants with RR-MS treated with DMF in clinical practice.

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.


Eligibility criteria: Key Inclusion Criteria:

* 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;
* Initiating oral DMF according to Summary of Product Characteristics (SmPC) at the inclusion visit;
* Expanded Disability Status Score (EDSS) under 6.

Key Exclusion Criteria:

* Participants with progressive form of Multiple Sclerosis (MS);
* With memory or psychiatric disorders preventing them to complete questionnaires in the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at Both 1 Month and 3 Months
timeFrame: 1 month and 3 months
measure: Percentage of Participant's with Adherence at 6 Months
timeFrame: 6 months
measure: Percentage of Participants by Reason of Oral Dimethyl Fumarate (DMF) Discontinuation at 3 Months and 6 Months
timeFrame: 3 month and 6 months
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: up to 6 months
measure: Percentage of Participants with Adverse Events (AEs) Related to Treatment
timeFrame: up to 6 months
measure: Percentage of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation
timeFrame: up to 6 months
measure: Percentage of Participants with Adverse Events (AEs) of Interest
timeFrame: up to 6 months
measure: Participant's Anxiety at Inclusion and at 6 Months
timeFrame: 0 months and 6 months
measure: Participant's Satisfaction Regarding Dimethyl Fumarate (DMF) Treatment at 6 Months
timeFrame: 6 months
measure: Participant's Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP)
timeFrame: 6 month
measure: Neurologists' Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Agen
country: France
facility: Ch D'Agen
city: Aix-en-Provence
country: France
facility: CH d'Aix-en-Provence
city: Amiens
country: France
facility: CHU Amiens
city: Amiens
country: France
facility: CHU D'amiens
city: Angoulême
country: France
facility: Cabinet Medical
city: Annecy
country: France
facility: Cabinet Medical Neurolac
city: Antibes
country: France
facility: CH Antibes
city: Antony
country: France
facility: Hopital Prive Antony
city: Arras
country: France
facility: CH d'Arras
city: Bastia
country: France
facility: CH de Bastia
city: Bayonne
country: France
facility: Chic de Bayonne
city: Belfort
country: France
facility: Cabinet du Dr Imad Malkoun
city: Biarritz
country: France
facility: Cabinet des Drs Chanel-Soulier et Cheron
city: Bordeaux
country: France
facility: Hôpital Pellegrin / Service : Neurologie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux-Caudéran
city: Carcassonne
country: France
facility: Ch de Carcassonne
city: Chatellerault
country: France
facility: Cabinet des Drs Farhat et Samad
city: Cholet
country: France
facility: Chde Cholet
city: Clamart
country: France
facility: HIA Percy
city: Clamart
country: France
facility: Pole de Sante Du Plateau
city: Cornebarrieu
country: France
facility: Clinique Des Cedres
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Dax
country: France
facility: Ch General Dax
city: Dijon
country: France
facility: Cabinet du Dr Pierre Gras
city: Dijon
country: France
facility: CHU Dijon
city: Douai
country: France
facility: Ch de Douai
city: Eaubonne
country: France
facility: CH Simone Veil d'Eaubonne
city: Gap
country: France
facility: Polyclinique des Alpes du Sud
city: Grenoble Cedex 9
country: France
facility: CHU Grenoble Alpes CS 10217
city: La Rochelle
country: France
facility: Cabinet médical
city: La Seyne-sur-Mer
country: France
facility: Pôle Espace Santé 2
city: Libourne
country: France
facility: Centre Hospitalier de Libourne
city: Lille
country: France
facility: Cabinet médical Montebello
city: Lons-le-Saunier
country: France
facility: Centre Hospitalier Intercommunal JURA-SUD
city: Lure
country: France
facility: Chi de Haute Saone
city: Lyon
country: France
facility: Cabinet Du Dr Neuschwander
city: Melun
country: France
facility: Hopital
city: Montauban
country: France
facility: CH de Montauban
city: Montpellier
country: France
facility: Centre Medical Odysseum
city: Montpellier
country: France
facility: Hopital Gui de Chaulliac
city: Mornant
country: France
facility: Cabinet des Drs Lorenzi Pernot et Guilloton
city: Muret
country: France
facility: Clinique d'Occitanie
city: Nimes
country: France
facility: Chu Caremeau
city: Nîmes
country: France
facility: CHU Carémeau
city: Orléans
country: France
facility: Hôpital de la Source
city: Paris
country: France
facility: Centre Cosem Miromesnil
city: Paris
country: France
facility: Cabinet du Dr Radia Djebbari
city: Paris
country: France
facility: Groupe Hospitalier Paris St Joseph
city: Paris
country: France
facility: Cabinet Médical Monceau
city: Pau
country: France
facility: Cabinet médical
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Quimper Cedex
country: France
facility: Chi de Cornouaille
city: Rambouillet
country: France
facility: Cabinet des Drs Gugenheim et Esna
city: Roanne
country: France
facility: Cabinet Du Dr Christophe Robin
city: Roubaix
country: France
facility: Hopital Victor Provo
city: Soissons
country: France
facility: CH de Soissons
city: Talence
country: France
facility: Cabinet du Dr Annick Gayou-Joyeux
city: Toulon
country: France
facility: HIA Sainte Anne
city: Toulouse cedex 9
country: France
facility: Hopital Pierre-Paul Riquet
city: Tours
country: France
facility: CHU Bretonneau
city: Troyes
country: France
facility: CH de Troyes
city: Valence
country: France
facility: CH de Valence
city: Évreux
country: France
facility: Cabinet de Dr Lotfi Kort
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: