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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Drug: Dimethyl Fumarate; Other: PSP

• Study Type: Observational
• Enrollment (Actual): 353

Contacts and Locations

Study Locations

• France
  • Agen, France, 47000
    • CH d'Agen
  • Aix-en-Provence, France, 13616
    • CH d'Aix-en-Provence
  • Amiens, France, 80000
    • CHU Amiens
  • Amiens, France, 80000
    • CHU d'Amiens
  • Angoulême, France, 16000
    • Cabinet Medical
  • Annecy, France, 74960
    • Cabinet Medical Neurolac
  • Antibes, France, 06600
    • CH Antibes
  • Antony, France, 92160
    • Hôpital Privé Antony
  • Arras, France, 62000
    • CH d'Arras
  • Bastia, France, 20600
    • CH de Bastia
  • Bayonne, France, 64100
    • Chic de Bayonne
  • Belfort, France, 90000
    • Cabinet du Dr Imad Malkoun
  • Biarritz, France, 64200
    • Cabinet des Drs Chanel-Soulier et Cheron
  • Bordeaux, France, 33200
    • Polyclinique Bordeaux-Caudéran
  • Bordeaux, France, 33000
    • Hôpital Pellegrin / Service : Neurologie
  • Carcassonne, France, 11000
    • CH de Carcassonne
  • Chatellerault, France, 86100
    • Cabinet des Drs Farhat et Samad
  • Cholet, France, 49300
    • Chde Cholet
  • Clamart, France, 92140
    • HIA Percy
  • Clamart, France, 92140
    • Pole de Sante du Plateau
  • Cornebarrieu, France, 31700
    • Clinique des Cèdres
  • Créteil, France, 94000
    • Hopital Henri Mondor
  • Dax, France, 40100
    • Ch General Dax
  • Dijon, France, 21000
    • CHU Dijon
  • Dijon, France, 21000
    • Cabinet du Dr Pierre Gras
  • Douai, France, 59500
    • CH de DOUAI
  • Eaubonne, France, 95600
    • CH Simone Veil d'Eaubonne
  • Gap, France, 05000
    • Polyclinique des Alpes du Sud
  • Grenoble Cedex 9, France, 38043
    • CHU Grenoble Alpes CS 10217
  • La Rochelle, France, 17000
    • Cabinet Medical
  • La Seyne-sur-Mer, France, 83500
    • Pôle Espace Santé 2
  • Libourne, France, 33500
    • Centre Hospitalier de Libourne
  • Lille, France, 59000
    • Cabinet médical Montebello
  • Lons-le-Saunier, France, 39016
    • Centre Hospitalier Intercommunal JURA-SUD
  • Lure, France, 70200
    • Chi de Haute Saone
  • Lyon, France, 69006
    • Cabinet Du Dr Neuschwander
  • Melun, France, 77000
    • Hopital
  • Montauban, France, 82000
    • CH de Montauban
  • Montpellier, France, 34000
    • Centre Medical Odysseum
  • Montpellier, France, 34090
    • Hopital Gui de Chaulliac
  • Mornant, France, 69440
    • Cabinet des Drs Lorenzi Pernot et Guilloton
  • Muret, France, 31600
    • Clinique D'Occitanie
  • Nimes, France, 30900
    • CHU Caremeau
  • Nîmes, France, 30900
    • CHU Caremeau
  • Orléans, France, 45100
    • Hôpital de la Source
  • Paris, France, 75014
    • Groupe Hospitalier Paris St Joseph
  • Paris, France, 75008
    • Centre Cosem Miromesnil
  • Paris, France, 75011
    • Cabinet du Dr Radia Djebbari
  • Paris, France, 75017
    • Cabinet Médical Monceau
  • Pau, France, 64000
    • Cabinet Medical
  • Poitiers, France, 86000
    • Centre Hospitalier Universitaire de Poitiers
  • Quimper Cedex, France, 29107
    • CHI de Cornouaille
  • Rambouillet, France, 78120
    • Cabinet des Drs Gugenheim et Esna
  • Roanne, France, 42300
    • Cabinet Du Dr Christophe Robin
  • Roubaix, France, 59100
    • Hopital Victor Provo
  • Soissons, France, 02200
    • CH de Soissons
  • Talence, France, 33400
    • Cabinet du Dr Annick Gayou-Joyeux
  • Toulon, France, 83000
    • HIA Sainte Anne
  • Toulouse cedex 9, France, 31059
    • Hôpital Pierre-Paul Riquet
  • Tours, France, 37000
    • Chu Bretonneau
  • Troyes, France, 10000
    • CH de Troyes
  • Valence, France, 26000
    • CH de Valence
  • Évreux, France, 27000
    • Cabinet de Dr Lotfi Kort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population included participants with RR-MS treated with DMF in clinical practice.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Drug: Dimethyl Fumarate; DMF as prescribed as standard of care.; Other Names: Tecfidera®
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).	Drug: Dimethyl Fumarate; DMF as prescribed as standard of care.; Other Names: Tecfidera®; Other: PSP; PSPs is to support patient care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at Both 1 Month and 3 Months	Persistence is defined as the percentage of participants still being treated by oral DMF at both 1 month and 3 months, according to routine practice.	1 month and 3 months
Percentage of Participant's with Adherence at 6 Months	Participant's adherence is assessed through the validated Girerd questionnaire. This is a 6-item self-questionnaire completed by participants with a scale of 0 for "Yes" and 1 for "No" for each question. Points for each question are summed up to obtain a global score between 0 if all the questions are ticked with "Yes" (reflecting a bad adherence), and 6 if all questions are ticked "No" (reflecting a good adherence).	6 months
Percentage of Participants by Reason of Oral Dimethyl Fumarate (DMF) Discontinuation at 3 Months and 6 Months	Discontinuation of DMF therapy is defined by the presence of any of the following criteria: definitive discontinuation declared by the physician during routine follow-up visit through electronic case report form (eCRF); a temporary stop declared by the physician during routine visit at 3 months, without DMF resumption declared at 6 months by the physician; a switch to another DMT declared by the physician during routine follow-up visit through eCRF.	3 month and 6 months
Percentage of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	up to 6 months
Percentage of Participants with Adverse Events (AEs) Related to Treatment		up to 6 months
Percentage of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation		up to 6 months
Percentage of Participants with Adverse Events (AEs) of Interest	AEs of interest includes gastrointestinal disorders, flush, lymphopenia.	up to 6 months
Participant's Anxiety at Inclusion and at 6 Months	Participant's anxiety is assessed through the Generalized Anxiety Disorder - 7 (GAD-7) self-questionnaire. The GAD-7 is a questionnaire that is used primarily to detect possible generalized anxiety disorders, disorders of panic, social anxiety and post-traumatic stress disorder. It is more specifically a self-questionnaire (completed by the participant) consisting of 7 items rated from 0 to 3. The total score is obtained by adding the score obtained to each item (score ranging from 0 to 21). A total score greater than 7 is suggestive of a generalized anxiety disorder.	0 months and 6 months
Participant's Satisfaction Regarding Dimethyl Fumarate (DMF) Treatment at 6 Months	Participant's satisfaction regarding DMF treatment is assessed through the validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score completed by the participant. The TSQM-9, a 9-items questionnaire, designed as a general measure of treatment satisfaction with medication. TSQM items are answered on 5- or 7-point Likert type scale and cover three domains, corresponding to distinct aspects related to the satisfaction of participants with their treatment (effectiveness, convenience and global satisfaction). A score can be obtained for each domain by summing the corresponding items transformed on a 0-100 scale. Higher value indicates more satisfaction, better perceived effectiveness, lower burden associated with better convenience.	6 months
Participant's Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP)	Participant's satisfaction is assessed at Month 6 using a questionnaire completed by the participant consisting of 3 questions. Questions 1 and 2 are assessed using a Likert scale (1-5) with scale range 1= Strongly disagree to 5= Strongly agree. Question 3 is assessed using the net promoter scale (1-7), where 1 indicates "not at all likely" and 7 indicates "extremely likely". Higher values indicate higher satisfaction.	6 month
Neurologists' Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP)	Neurologist's satisfaction is assessed after the last participant last visit of the site center using a 10-item questionnaire, completed by the physician. Question (Q) 1, Q3, Q4, Q6, Q7, Q8= is answered "Yes/No"; Q2= Lack of time, Lack of interest, Patient refused, Forget, No registration form available, Registration process too complicated / Other: specify; Q5= The availability of the call center, The monitoring of patient compliance, The coordination of biological assessments, Other: specify; Q9: 1 bad satisfaction, 10 good satisfaction and Q10 was an open answer.	up to 6 months

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): September 14, 2022
• Study Completion (Actual): September 14, 2022

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: FRA-BGT-18-11469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No