Multiple Sclerosis, Relapsing-remittingNCT05366036
A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis
An observational study of Multiple Sclerosis, Relapsing-remitting, run by Eisai Korea Inc. at 20 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting
- How many people
- 172 participants
- Where
- 20 sitesSouth Korea
- Study dates
- 14 Jun 2017to 14 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Korean participants with relapsing-remitting MS will be included in this study.
Who may be able to join
- The decision by the treating physician to prescribe Tecfidera is made before participating in the post marketing surveillance (PMS)
- A participant data release consent form is signed and dated by the participant and/or legal representative
- A Korean participant is diagnosed as relapsing-remitting MS per approved Korean label
Who cannot join
- Participants with hypersensitivity to active ingredient or any of the excipients of Tecfidera according to the approved Korean label
- Participants with unresolved serious infection
- Participants who are participating in another study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites
Site #15
Ansan, Gyeonggi-do
Site #08
Bucheon-si, Gyeonggi-do
Site #02
Busan
Site #16
Busan
Site #23
Changwon, Gyeongsangnam-do
Site #20
Cheonan, Chungcheongnam-do
Site #01
Daegu
Site #17
Daegu
Site #07
Daejeon
Site #09
Goyang-si, Gyeonggi-do
Site #14
Goyang-si, Gyeonggi-do
Site #13
Jinju, Gyeongsangnam-do
Site #03
Kwangju
Site #04
Seoul
Site #06
Seoul
Site #11
Seoul
Site #12
Seoul
Site #18
Seoul
Site #19
Seoul
Site #21
Seoul
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Being tested
- No Intervention
- Keywords
- MS0008, Dimethyl Fumarate, Multiple sclerosis, Tecfidera, Korean participants
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: Up to 24 months
Number of Gadolinium (Gd) Enhancing Lesions
Number of Gd enhancing lesions will be observed using magnetic resonance imaging (MRI) scans.
Measured: 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).
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start14 Jun 2017
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-remittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366036
- Sponsor's protocol ID
- MS0008
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Patients With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05366036
- Acronym / sponsor ID
- MS0008
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Keywords
- MS0008, Dimethyl Fumarate, Multiple sclerosis, Tecfidera, Korean participants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with MS | – | Other: No InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Korean participants with relapsing-remitting MS will be included in this study.
Key inclusion criteria (3 listed)
- The decision by the treating physician to prescribe Tecfidera is made before participating in the post marketing surveillance (PMS)
- A participant data release consent form is signed and dated by the participant and/or legal representative
- A Korean participant is diagnosed as relapsing-remitting MS per approved Korean label
Key exclusion criteria (3 listed)
- Participants with hypersensitivity to active ingredient or any of the excipients of Tecfidera according to the approved Korean label
- Participants with unresolved serious infection
- Participants who are participating in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Participants with MS |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 24 months
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.
Number of Participants With Adverse Drug Reactions (ADRs)
Time frame: Up to 24 months
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.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 24 months
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.
Number of Participants With Serious Adverse Drug Reactions (SADRs)
Time frame: Up to 24 months
SADRs are defined as SAEs considered related to Tecfidera by the treating physician.
Number of Participants With Unexpected AEs
Time frame: Up to 24 months
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.
Number of Participants With Unexpected ADRs
Time frame: Up to 24 months
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.
4 secondary outcomes
Annualized Relapse Rate
Time frame: Up to 24 months
Percentage of Relapsing Participants
Time frame: Up to 24 months
Number of Gadolinium (Gd) Enhancing Lesions
Time frame: Up to 24 months
Change from Baseline in Participant's Global Efficacy Assessment by the Treating Physician
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-remitting, run by Eisai Korea Inc. at 20 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.