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

Biogen

Status: Completed

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Dimethyl Fumarate; Other: PSP

Study type: Observational

Funder types: Industry

Identifiers

NCT04221191

FRA-BGT-18-11469

Details and patient eligibility

About

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.

Enrollment: 353 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

353 participants in 2 patient groups

Standard of Care (SoC) Group

Description:

SoC neurologists will include and follow-up all study participants who receive DMF according to their standard of care practice (non-coached participants).

Treatment:

Drug: Dimethyl Fumarate

OroSEP PSP (OPSP) Group

Description:

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).

Treatment:

Other: PSP

Drug: Dimethyl Fumarate