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Clinical Trials in Taiwan / NCT04480853
Recruiting Phase 4

Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis

NCT04480853 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 4
Started
2020-10-12
Last updated
2026-06-26

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Fingolimod →

Fingolimod: Fingolimod 0.5 mg QD, oral

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: -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) Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Novartis Investigative Site Kaohsiung City Taiwan Recruiting
Novartis Investigative Site Taichung Taiwan Recruiting
Novartis Investigative Site Tainan Taiwan Withdrawn
Novartis Investigative Site Taipei Taiwan Recruiting
Novartis Investigative Site Taipei Taiwan Withdrawn
Novartis Investigative Site Taoyuan Taiwan Withdrawn

More Novartis Pharmaceuticals trials in Taiwan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04480853 on ClinicalTrials.gov ↗ ← All trials in Taiwan