Status:
RECRUITING
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
20-100 years
Phase:
PHASE4
Brief 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 fingo...
Detailed Description
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 new...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04480853
Start Date
October 12 2020
End Date
September 30 2027
Last Update
October 16 2025
Active Locations (6)
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1
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
2
Novartis Investigative Site
Taichung, Taiwan, 407219
3
Novartis Investigative Site
Tainan, Taiwan, 70403
4
Novartis Investigative Site
Taipei, Taiwan, 10002