Clinical trial NCT05366036: A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis
Official title: Post Marketing Surveillance Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Patients With Relapsing-Remitting Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-remitting
Keywords: MS0008
Dimethyl Fumarate
Multiple sclerosis
Tecfidera
Korean participants
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-09
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean participants with relapsing-remitting MS will be included in this study.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 24 months
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: Up to 24 months
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 24 months
measure: Number of Participants With Serious Adverse Drug Reactions (SADRs)
timeFrame: Up to 24 months
measure: Number of Participants With Unexpected AEs
timeFrame: Up to 24 months
measure: Number of Participants With Unexpected ADRs
timeFrame: Up to 24 months
Secondary outcomes:
measure: Annualized Relapse Rate
timeFrame: Up to 24 months
measure: Percentage of Relapsing Participants
timeFrame: Up to 24 months
measure: Number of Gadolinium (Gd) Enhancing Lesions
timeFrame: Up to 24 months
measure: Change from Baseline in Participant's Global Efficacy Assessment by the Treating Physician
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Site #20
state: Chungcheongnam-do
city: Ansan
country: Korea, Republic of
facility: Site #15
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Site #08
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Site #09
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Site #14
state: Gyeonggi-do
city: Changwon
country: Korea, Republic of
facility: Site #23
state: Gyeongsangnam-do
city: Jinju
country: Korea, Republic of
facility: Site #13
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Site #02
city: Busan
country: Korea, Republic of
facility: Site #16
city: Daegu
country: Korea, Republic of
facility: Site #01
city: Daegu
country: Korea, Republic of
facility: Site #17
city: Daejeon
country: Korea, Republic of
facility: Site #07
city: Kwangju
country: Korea, Republic of
facility: Site #03
city: Seoul
country: Korea, Republic of
facility: Site #04
city: Seoul
country: Korea, Republic of
facility: Site #06
city: Seoul
country: Korea, Republic of
facility: Site #11
city: Seoul
country: Korea, Republic of
facility: Site #12
city: Seoul
country: Korea, Republic of
facility: Site #18
city: Seoul
country: Korea, Republic of
facility: Site #19
city: Seoul
country: Korea, Republic of
facility: Site #21
Study officials:
References: