A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Number of Adverse Events of Special Interest(AESI)
研究概览
简要总结
The purpose of the study is to describe the safety profile of fingolimod in the Taiwanese multiple sclerosis population. This study aims to collect the safety data in patients newly initiated on fingolimod for one year.
详细描述
This is a 12-month, prospective, interventional, multi-center study to monitor safety in adult patients with relapsing-remitting multiple sclerosis (RRMS) in Taiwan who based on local practice are newly starting fingolimod at the time of study entry.
Thirty-four patients will be included in this study in line with the study inclusion and exclusion criteria. After entering this study, the participants will continue to be treated for MS based on local practice. The patient will be taking fingolimod 0.5mg per day. Protocol-mandated procedures and visits for safety data collection will be conducted in addition to the required examinations according to the clinical practice.
If a patient experienced an interruption of fingolimod treatment that requires a re-evaluation of FDO, the patient will be discontinued from the study. If the treatment interruption does not require a FDO when re-starting fingolimod, the patient can continue to participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsing-remitting multiple sclerosis that are fingolimod treatment naive at the time of study entry and are newly starting fingolimod based on physician judgement and according to Taiwan's fingolimod package insert (version TWI-090420)
排除标准
- •Patients with the diagnosis of neuromyelitis optica.
- •Patients who are being treated with any investigational drug at the time of study entry.
- •In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or Class III/IV heart failure
- •A history or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient has a functioning pacemaker
- •A baseline QTc interval ≥ 500 msec
- •Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs
- •Patient with known immune deficiency, increased risk of opportunistic infection, severe active infection or chronic active infection.
- •Patients with severe active malignancies, except for basal cell epithelioma
- •Patients with severe hepatic insufficiency
- •Pregnant or nursing (lactating) women or women of childbearing potential unless on contraception
研究组 & 干预措施
Fingolimod
Open label Fingolimod 0.5 mg capsule taken once daily, oral.
干预措施: Fingolimod (Drug)
结局指标
主要结局
Number of Adverse Events of Special Interest(AESI)
时间窗: First Dose Observation on the first day of taking findolimod
The adverse events of special interest (AESI) include bradycardia and Grade 2 or higher AV block during First Dose Observation.
Number of Adverse Events of Special Interest (AESI)
时间窗: Baseline up to 12 months
The adverse events of special interest (AESI) include macular edema, abnormal liver function(ALT, AST or GGT \> 5x upper normal limit), and severe lymphocytopenia(lymphocyte \< 200 cells/μL).
次要结局
- Annualized relapse reate (ARR)(Baseline up to 12 months)
- Change from baseline of blood pressure (mmHg)(Baseline up to 12 months)
- Change from baseline of Pulse (beats/min)(Baseline up to 12 months)