Post Marketing Surveillance Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Patients With Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 20
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs)
时间窗: 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)
时间窗: Up to 24 months
SADRs are defined as SAEs considered related to Tecfidera by the treating physician.
Number of Participants With Unexpected AEs
时间窗: 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 Adverse Events (AEs)
时间窗: 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)
时间窗: 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 Unexpected ADRs
时间窗: 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.
次要结局
- Percentage of Relapsing Participants(Up to 24 months)
- Annualized Relapse Rate(Up to 24 months)
- Number of Gadolinium (Gd) Enhancing Lesions(Up to 24 months)
- Change from Baseline in Participant's Global Efficacy Assessment by the Treating Physician(Up to 24 months)