Multiple Sclerosis, Relapsing-Remitting
Conditions
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.
Interventions
DRUGDimethyl Fumarate
DMF as prescribed as standard of care.
OTHERPSP
PSPs is to support patient care.
Sponsors
Biogen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) 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. |
| 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. |
| 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. |
Countries
France
Outcome results
None listed