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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Dimethyl Fumarate
* Other: PSP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care (SoC) Group<br>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<br>* DMF as prescribed as standard of care.<br>* Other names: Tecfidera®;|
| OroSEP PSP (OPSP) Group<br>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<br>* DMF as prescribed as standard of care.<br>* Other names: Tecfidera®;Other: PSP<br>* PSPs is to support patient care.<br>|

What is the study measuring?
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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 |