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

  • STATUS
    Recruiting
  • End date
    Feb 19, 2022
  • participants needed
    350
  • sponsor
    Biogen
Updated on 6 May 2021
Investigator
Biogen
Primary Contact
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fumarate
tecfidera
relapsing multiple sclerosis

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.

Details
Condition relapsing-remitting multiple sclerosis
Treatment dimethyl fumarate, PSP, PSP
Clinical Study IdentifierNCT04221191
SponsorBiogen
Last Modified on6 May 2021

Eligibility

Yes No Not Sure

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

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
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