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Multiple SclerosisPhase 4SPRINGNCT04480853

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

A Phase 4 study testing Fingolimod in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 3 sites in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 100 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Fingolimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesTaiwan
Study dates
12 Oct 2020to 30 Sep 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Novartis Investigative Site

    Kaohsiung City, 83301

  • Novartis Investigative Site

    Taichung, 407219

  • Novartis Investigative Site

    Taipei, 10002

Other trials in Taiwan

About this study

Official title: 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)

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.

Read the 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 newly starting fingolimod at the time of study entry.

Thirty-four patients will be included in this study in line with the study inclusion and exclusion criteria. After entering this study, the participants will continue to be treated for MS based on local practice. The patient will be taking fingolimod 0.5mg per day. Protocol-mandated procedures and visits for safety data collection will be conducted in addition to the required examinations according to the clinical practice.

If a patient experienced an interruption of fingolimod treatment that requires a re-evaluation of FDO, the patient will be discontinued from the study. If the treatment interruption does not require a FDO when re-starting fingolimod, the patient can continue to participate in this study.

Being tested
Fingolimod
Keywords
Fingolimod, Multiple sclerosis, Relapsing-remitting multiple sclerosis, Relapsing-remitting, Post-authorization study, Adult, MS
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FingolimodDrug

    Also called FTY720

    Fingolimod 0.5 mg QD, oral

Study groups in NCT04480853
Study groupRoleWhat they receive
FingolimodExperimentalOpen label Fingolimod 0.5 mg capsule taken once daily, oral.
Receives: Drug: Fingolimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events of Special Interest(AESI)

    The adverse events of special interest (AESI) include bradycardia and Grade 2 or higher AV block during First Dose Observation.

    Measured: First Dose Observation on the first day of taking findolimod

  2. Number of Adverse Events of Special Interest (AESI)

    The adverse events of special interest (AESI) include macular edema, abnormal liver function(ALT, AST or GGT > 5x upper normal limit), and severe lymphocytopenia(lymphocyte < 200 cells/μL).

    Measured: Baseline up to 12 months

Secondary outcomes (3)

  1. Annualized relapse reate (ARR)

    The ARR will be calculated as total number of relapses experienced divided by total number of days of follow-up, and the ratio multiplied by 365. For patients withdraw from the study or switch to an alternative MS therapy prior to 12 month, the total number of days in study is defined as the number of days from baseline to the last date in study.

    Measured: Baseline up to 12 months

  2. Change from baseline of Pulse (beats/min)

    Pulse (beats/min - bpm) data will be summarized as descriptive statistics for change from baseline value (both for the period 6-hours post first dose and for further visit assessments). The frequency and percentage of notable vital sign abnormalities will be summarized. Notable criteria for pulse is > 120bpm or Increase of ≥15 bpm from baseline Or < 50bpm or Decrease of ≥15 bpm from baseline

    Measured: Baseline up to 12 months

  3. Change from baseline of blood pressure (mmHg)

    Blood pressure(BP)(mmHg) data will be summarized as descriptive statistics for change from baseline value (both for the period 6-hours post first dose and for further visit assessments). The frequency and percentage of notable vital sign abnormalities will be summarized. Notable criteria for systolic BP is ≥160 mm Hg or Increase of ≥20 mm Hg from baseline Or ≤ 90 mm Hg or Decrease of ≥ 20 mm Hg from baseline. Notable criteria for diastolic BP is ≥ 100 mmHg or Increase of ≥ 15 mm Hg from baseline Or ≤ 50 mmHg or Decrease of ≥ 15 mm Hg from baseline.

    Measured: Baseline up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start12 Oct 2020
  3. Primary completion15 Oct 2026
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480853
Sponsor's protocol ID
CFTY720DTW03
Acronym
SPRING
Status last verified
Jun 2026
First submitted
17 Jul 2020
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fingolimod in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events of Special Interest(AESI) (time frame: First Dose Observation on the first day of taking findolimod). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04480853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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