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

NCT ID: NCT05366036

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-14

Study Completion Date

2022-01-14

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-remitting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with MS

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.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site #20

Cheonan, Chungcheongnam-do, South Korea

Site Status

Site #15

Ansan, Gyeonggi-do, South Korea

Site Status

Site #08

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Site #09

Goyang-si, Gyeonggi-do, South Korea

Site Status

Site #14

Goyang-si, Gyeonggi-do, South Korea

Site Status

Site #23

Changwon, Gyeongsangnam-do, South Korea

Site Status

Site #13

Jinju, Gyeongsangnam-do, South Korea

Site Status

Site #02

Busan, , South Korea

Site Status

Site #16

Busan, , South Korea

Site Status

Site #01

Daegu, , South Korea

Site Status

Site #17

Daegu, , South Korea

Site Status

Site #07

Daejeon, , South Korea

Site Status

Site #03

Kwangju, , South Korea

Site Status

Site #04

Seoul, , South Korea

Site Status

Site #06

Seoul, , South Korea

Site Status

Site #11

Seoul, , South Korea

Site Status

Site #12

Seoul, , South Korea

Site Status

Site #18

Seoul, , South Korea

Site Status

Site #19

Seoul, , South Korea

Site Status

Site #21

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MS0008

Identifier Type: -

Identifier Source: org_study_id

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