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

May 28, 2026 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Novartis Investigative Site
      • Taichung, Taiwan, 407219
        • Recruiting
        • Novartis Investigative Site
      • Tainan, Taiwan, 704302
        • Withdrawn
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 11220
        • Withdrawn
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Withdrawn
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fingolimod
Open label Fingolimod 0.5 mg capsule taken once daily, oral.
Drug: Fingolimod
Fingolimod 0.5 mg QD, oral
Other Names:
  • FTY720

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adverse Events of Special Interest(AESI)
Time Frame: First Dose Observation on the first day of taking findolimod
The adverse events of special interest (AESI) include bradycardia and Grade 2 or higher AV block during First Dose Observation.
First Dose Observation on the first day of taking findolimod
Number of Adverse Events of Special Interest (AESI)
Time Frame: Baseline up to 12 months
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).
Baseline up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Annualized relapse reate (ARR)
Time Frame: Baseline up to 12 months
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.
Baseline up to 12 months
Change from baseline of Pulse (beats/min)
Time Frame: Baseline up to 12 months
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
Baseline up to 12 months
Change from baseline of blood pressure (mmHg)
Time Frame: Baseline up to 12 months
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.
Baseline up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CFTY720DTW03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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