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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-remitting
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Korean participants with relapsing-remitting MS will be included in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Intervention; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of Gadolinium (Gd) Enhancing Lesions	Number of Gd enhancing lesions will be observed using magnetic resonance imaging (MRI) scans.	Up to 24 months
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

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Dimethyl Fumarate; Tecfidera; Korean participants; MS0008
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: MS0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No