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)
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Oct 12, 2020
Jul 15, 2022
20 Years and older (Adult, Older Adult)
Fingolimod 0.5 mg QD, oral
-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