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