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)
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).
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.
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