Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— TEC-ADHERE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04221191
• Other study ID #: FRA-BGT-18-11469
• Status: Completed
• Start date: August 19, 2019
• Est. completion date: September 14, 2022

Study information

• Verified date: July 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: September 14, 2022
• Est. primary completion date: September 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Dimethyl Fumarate
DMF as prescribed as standard of care.

Other:
• PSP
PSPs is to support patient care.

Locations

Country	Name	City	State
France	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	Chatellerault
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 Cedex 9
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	Nimes
France	CHU Carémeau	Nîmes
France	Hôpital de la Source	Orléans
France	Cabinet du Dr Radia Djebbari	Paris
France	Cabinet Médical Monceau	Paris
France	Centre Cosem Miromesnil	Paris
France	Groupe Hospitalier Paris St Joseph	Paris
France	Cabinet médical	Pau
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Chi de Cornouaille	Quimper Cedex
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 cedex 9
France	CHU Bretonneau	Tours
France	CH de Troyes	Troyes
France	CH de Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants with Adverse Events (AEs) Related to Treatment		up to 6 months
Secondary	Percentage of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation		up to 6 months
Secondary	Percentage of Participants with Adverse Events (AEs) of Interest	AEs of interest includes gastrointestinal disorders, flush, lymphopenia.	up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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