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

Launched by NOVARTIS PHARMACEUTICALS · Jul 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called fingolimod in adults aged 20 and older who have relapsing-remitting multiple sclerosis (MS) in Taiwan. The goal is to gather information about how well the medication works and any potential side effects in patients who are just starting treatment. The study is currently looking for participants who have never taken fingolimod before and have been diagnosed with this type of MS.

To be eligible for the trial, participants should not have any other serious heart conditions or diseases that could complicate their treatment, and they should not be pregnant or nursing. Those who join the study can expect to be monitored for one year to see how they respond to fingolimod, with regular check-ups to assess their health and any side effects. This research is important as it will help doctors understand how fingolimod works in the Taiwanese MS population.

Gender

ALL

Eligibility criteria

• 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