RecruitingPhase 4NCT04480853
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
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)
Sponsor
Novartis Pharmaceuticals
Enrollment
30 participants
Start Date
Oct 12, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 20 YearsMax Age: 100 Years
Inclusion Criteria1
- 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 Criteria10
- 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
Interventions
DRUGFingolimod
Fingolimod 0.5 mg QD, oral
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04480853
Related Trials
From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis
NCT048734921 location
Upper Limb Nerve Cryoneurolysis is Non Inferior to the Usual Care and Has Therapeutic Add Value in Dealing With Shoulder Pain and Functional Problems Caused by Spasticity and Motor Impairment
NCT067824641 location
Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis
NCT074776392 locations
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
NCT0381634552 locations
Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
NCT072253611 location