A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis

Eisai

Status: Completed

Conditions: Multiple Sclerosis, Relapsing-remitting

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05366036

MS0008

Details and patient eligibility

About

The primary purpose of this study is to evaluate the overall safety and efficacy of Tecfidera (Dimethyl Fumarate) as an oral treatment for Korean participants with relapsing-remitting multiple sclerosis (MS) under routine clinical practice.

Enrollment: 172 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The decision by the treating physician to prescribe Tecfidera is made before participating in the post marketing surveillance (PMS)
2. A participant data release consent form is signed and dated by the participant and/or legal representative
3. A Korean participant is diagnosed as relapsing-remitting MS per approved Korean label

Exclusion criteria

1. Participants with hypersensitivity to active ingredient or any of the excipients of Tecfidera according to the approved Korean label
2. Participants with unresolved serious infection
3. Participants who are participating in another study

Trial design

172 participants in 1 patient group

Participants with MS

Description:

Participants with relapsing-remitting MS who are newly prescribed and will start treatment with Tecfidera in a real-world clinical practice setting will be observed prospectively for up to 24 months.

Treatment:

Other: No Intervention