Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
- Registration Number
- NCT04480853
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
-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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fingolimod Fingolimod Open label Fingolimod 0.5 mg capsule taken once daily, oral.
- Primary Outcome Measures
Name Time Method Number of Adverse Events of Special Interest(AESI) 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) 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).
- Secondary Outcome Measures
Name Time Method Annualized relapse reate (ARR) Baseline up to 12 months The ARR will be calculated as total number of relapses experienced divided by total number of days of follow-up, and the ratio multiplied by 365. For patients withdraw from the study or switch to an alternative MS therapy prior to 12 month, the total number of days in study is defined as the number of days from baseline to the last date in study.
Change from baseline of blood pressure (mmHg) Baseline up to 12 months Blood pressure(BP)(mmHg) data will be summarized as descriptive statistics for change from baseline value (both for the period 6-hours post first dose and for further visit assessments). The frequency and percentage of notable vital sign abnormalities will be summarized. Notable criteria for systolic BP is ≥160 mm Hg or Increase of ≥20 mm Hg from baseline Or ≤ 90 mm Hg or Decrease of ≥ 20 mm Hg from baseline. Notable criteria for diastolic BP is ≥ 100 mmHg or Increase of ≥ 15 mm Hg from baseline Or ≤ 50 mmHg or Decrease of ≥ 15 mm Hg from baseline.
Change from baseline of Pulse (beats/min) Baseline up to 12 months Pulse (beats/min - bpm) data will be summarized as descriptive statistics for change from baseline value (both for the period 6-hours post first dose and for further visit assessments). The frequency and percentage of notable vital sign abnormalities will be summarized. Notable criteria for pulse is \> 120bpm or Increase of ≥15 bpm from baseline Or \< 50bpm or Decrease of ≥15 bpm from baseline
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇳Taoyuan, Taiwan