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

Korábbi kezelés

• Patients who are being treated with any investigational drug at the time of study entry.
• Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs

Más betegség

• 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
• 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

Laborértékek

• A baseline QTc interval ≥ 500 msec

Egyéb

• Patients with the diagnosis of neuromyelitis optica.
• Pregnant or nursing (lactating) women or women of childbearing potential unless on contraception

• -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)