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

Multiple Sclerosis, Relapsing-remitting Clinical Trial

Official title:

Post Marketing Surveillance Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Patients With Relapsing-Remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366036
• Other study ID #: MS0008
• Status: Completed
• Start date: June 14, 2017
• Est. completion date: January 14, 2022

Study information

• Verified date: May 2022
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
Korea, Republic of	Site #15	Ansan	Gyeonggi-do
Korea, Republic of	Site #08	Bucheon	Gyeonggi-do
Korea, Republic of	Site #02	Busan
Korea, Republic of	Site #16	Busan
Korea, Republic of	Site #23	Changwon	Gyeongsangnam-do
Korea, Republic of	Site #20	Cheonan	Chungcheongnam-do
Korea, Republic of	Site #01	Daegu
Korea, Republic of	Site #17	Daegu
Korea, Republic of	Site #07	Daejeon
Korea, Republic of	Site #09	Goyang	Gyeonggi-do
Korea, Republic of	Site #14	Goyang	Gyeonggi-do
Korea, Republic of	Site #13	Jinju	Gyeongsangnam-do
Korea, Republic of	Site #03	Kwangju
Korea, Republic of	Site #04	Seoul
Korea, Republic of	Site #06	Seoul
Korea, Republic of	Site #11	Seoul
Korea, Republic of	Site #12	Seoul
Korea, Republic of	Site #18	Seoul
Korea, Republic of	Site #19	Seoul
Korea, Republic of	Site #21	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug.	Up to 24 months
Primary	Number of Participants With Adverse Drug Reactions (ADRs)	An ADR is defined as all the adverse and unintended responses which are generated from the normal administration/use of study drugs which are cases of not excluding the casual relationship with the study drug, and which shall be regarded as ADRs in the case the relationship with study drug is not known among AEs reported voluntarily.	Up to 24 months
Primary	Number of Participants With Serious Adverse Events (SAEs)	A SAE is defined as any untoward medical occurrence at any dose that meets any of the following criteria: is fatal or life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; or includes other important medical events.	Up to 24 months
Primary	Number of Participants With Serious Adverse Drug Reactions (SADRs)	SADRs are defined as SAEs considered related to Tecfidera by the treating physician.	Up to 24 months
Primary	Number of Participants With Unexpected AEs	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug. Expectedness of events are determined according to the approved local label. Unexpected AE is except for any expectedness of events. An unexpected AE is defined as an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug.	Up to 24 months
Primary	Number of Participants With Unexpected ADRs	An ADR is defined as all the adverse and unintended responses which are generated from the normal administration/use of study drugs which are cases of not excluding the casual relationship with the study drug, and which shall be regarded as ADRs in the case the relationship with study drug is not known among AEs reported voluntarily. Expectedness of events will be determined according to the approved local label. Unexpected ADR means except for any expected ADR in local label. An unexpected ADR is defined as an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug.	Up to 24 months
Secondary	Annualized Relapse Rate	Annualized relapse rate will be calculated as the total number of relapses experienced divided by the total number of participant-years on study treatment. A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event.	Up to 24 months
Secondary	Percentage of Relapsing Participants	Percentage of relapsing participants will be assessed at the time of 24 months from the first administration of Tecfidera. A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event.	Up to 24 months
Secondary	Number of Gadolinium (Gd) Enhancing Lesions	Number of Gd enhancing lesions will be observed using magnetic resonance imaging (MRI) scans.	Up to 24 months
Secondary	Change from Baseline in Participant's Global Efficacy Assessment by the Treating Physician	Global efficacy assessment will be evaluated according to the treating physician's clinical discretion with 3-point rating scale at the time of 24 months from the first administration considering participant's overall condition compared to baseline. The score ranges from 1-3. The 3-point rating scale is classified as: 1=Improvement (symptoms are improved, or it is considered as maintaining effect after administration of Tecfidera). Maintaining effect is defined as it is highly expected that Tecfidera discontinuation worsens symptoms, or the same effect is persistent when the previous drug is replaced by Tecfidera; 2=No change (no changes were seen compared to before administration of Tecfidera without any change in concomitant medication or treatment related to MS; not considered as maintaining effect); 3=Worsening (symptoms are worsened compared to before administration of Tecfidera).	Up to 24 months