Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: Dimethyl FumarateOther: PSP
- Registration Number
- NCT04221191
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OroSEP PSP (OPSP) Group PSP 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). Standard of Care (SoC) Group Dimethyl Fumarate 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 Dimethyl Fumarate 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).
- Primary Outcome Measures
Name Time Method Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at 6 Months 6 months Persistence is defined as the percentage of participant still being treated by oral DMF at 6 months, according to routine visit.
- Secondary Outcome Measures
Name Time Method Participant's Anxiety at Inclusion and at 6 Months 0 months and 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.
Participant's Satisfaction Regarding Dimethyl Fumarate (DMF) Treatment at 6 Months 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.
Percentage of Participants with Adverse Events (AEs) up to 6 months 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.
Participant's Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP) 6 month 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.
Neurologists' Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP) up to 6 months 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.
Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at Both 1 Month and 3 Months 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.
Percentage of Participant's with Adherence at 6 Months 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).
Percentage of Participants by Reason of Oral Dimethyl Fumarate (DMF) Discontinuation at 3 Months and 6 Months 3 month 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.
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 up to 6 months AEs of interest includes gastrointestinal disorders, flush, lymphopenia.
Trial Locations
- Locations (62)
Pole de Sante Du Plateau
🇫🇷Clamart, France
Cabinet du Dr Pierre Gras
🇫🇷Dijon, France
Cabinet médical Montebello
🇫🇷Lille, France
CH de Montauban
🇫🇷Montauban, France
Centre Medical Odysseum
🇫🇷Montpellier, France
Hopital Prive Antony
🇫🇷Antony, France
Hôpital Pellegrin / Service : Neurologie
🇫🇷Bordeaux, France
CH de Bastia
🇫🇷Bastia, France
Cabinet du Dr Imad Malkoun
🇫🇷Belfort, France
Cabinet des Drs Farhat et Samad
🇫🇷Chatellerault, France
CH d'Arras
🇫🇷Arras, France
Cabinet des Drs Chanel-Soulier et Cheron
🇫🇷Biarritz, France
Ch de Carcassonne
🇫🇷Carcassonne, France
Chic de Bayonne
🇫🇷Bayonne, France
Polyclinique Bordeaux-Caudéran
🇫🇷Bordeaux, France
CHU Dijon
🇫🇷Dijon, France
CHU Grenoble Alpes CS 10217
🇫🇷Grenoble Cedex 9, France
Cabinet médical
🇫🇷Pau, France
Pôle Espace Santé 2
🇫🇷La Seyne-sur-Mer, France
Clinique Des Cedres
🇫🇷Cornebarrieu, France
Hopital Henri Mondor
🇫🇷Créteil, France
Ch General Dax
🇫🇷Dax, France
Hopital Gui de Chaulliac
🇫🇷Montpellier, France
Clinique d'Occitanie
🇫🇷Muret, France
CHU Carémeau
🇫🇷Nîmes, France
CH Simone Veil d'Eaubonne
🇫🇷Eaubonne, France
Cabinet Du Dr Neuschwander
🇫🇷Lyon, France
Chu Caremeau
🇫🇷Nimes, France
Hôpital de la Source
🇫🇷Orléans, France
Centre Hospitalier de Libourne
🇫🇷Libourne, France
Centre Hospitalier Intercommunal JURA-SUD
🇫🇷Lons-le-Saunier, France
Cabinet des Drs Lorenzi Pernot et Guilloton
🇫🇷Mornant, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Hopital Victor Provo
🇫🇷Roubaix, France
HIA Sainte Anne
🇫🇷Toulon, France
CHU Bretonneau
🇫🇷Tours, France
CH de Valence
🇫🇷Valence, France
Cabinet Du Dr Christophe Robin
🇫🇷Roanne, France
CH de Troyes
🇫🇷Troyes, France
Ch D'Agen
🇫🇷Agen, France
CH d'Aix-en-Provence
🇫🇷Aix-en-Provence, France
CHU Amiens
🇫🇷Amiens, France
Cabinet Medical
🇫🇷Angoulême, France
CHU D'amiens
🇫🇷Amiens, France
Cabinet Medical Neurolac
🇫🇷Annecy, France
CH Antibes
🇫🇷Antibes, France
Ch de Douai
🇫🇷Douai, France
Polyclinique des Alpes du Sud
🇫🇷Gap, France
Chde Cholet
🇫🇷Cholet, France
HIA Percy
🇫🇷Clamart, France
Chi de Haute Saone
🇫🇷Lure, France
Hopital
🇫🇷Melun, France
Centre Cosem Miromesnil
🇫🇷Paris, France
Cabinet du Dr Radia Djebbari
🇫🇷Paris, France
Groupe Hospitalier Paris St Joseph
🇫🇷Paris, France
Chi de Cornouaille
🇫🇷Quimper Cedex, France
Cabinet des Drs Gugenheim et Esna
🇫🇷Rambouillet, France
CH de Soissons
🇫🇷Soissons, France
Cabinet du Dr Annick Gayou-Joyeux
🇫🇷Talence, France
Hopital Pierre-Paul Riquet
🇫🇷Toulouse cedex 9, France
Cabinet Médical Monceau
🇫🇷Paris, France
Cabinet de Dr Lotfi Kort
🇫🇷Évreux, France