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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethyl Fumarate | Drug | DMF as prescribed as standard of care. |
|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study population included participants with RR-MS treated with DMF in clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch D'Agen | Agen | 47000 | France | |||
| CH d'Aix-en-Provence |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39527163 | Derived | 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. |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
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| PSP | Other | PSPs is to support patient care. |
|
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 |
| 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 |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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