NCT04480853Active, not recruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 17 Jul 2020
- Start date
- 12 Oct 2020
- Primary completion date
- 15 Oct 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT04480853
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 14
- From 12 Oct 2020 to the primary completion date, 15 Oct 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- A baseline QTc interval ≥ 500 msec
Other
- Patients with the diagnosis of neuromyelitis optica.
- Pregnant or nursing (lactating) women or women of childbearing potential unless on contraception
Who the study is looking for
- -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)
Age in the registry: 20 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.