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

NCT04480853 | Recruiting Phase 4

• 1 other identifier: CFTY720DTW03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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 fingolimod for one year.

Conditions

Multiple Sclerosis

Keywords

Fingolimod; Multiple sclerosis; Relapsing-remitting multiple sclerosis; Relapsing-remitting; Post-authorization study; Adult; MS

Outcome Measures

Primary Outcomes (2)

• 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.

  First Dose Observation on the first day of taking findolimod

• 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).

  Baseline up to 12 months

Secondary Outcomes (3)

• Annualized relapse reate (ARR)

  Baseline up to 12 months

• Change from baseline of Pulse (beats/min)

  Baseline up to 12 months

• Change from baseline of blood pressure (mmHg)

  Baseline up to 12 months

Study Arms (1)

Fingolimod

EXPERIMENTAL

Open label Fingolimod 0.5 mg capsule taken once daily, oral.

Drug: Fingolimod

Interventions

Fingolimod DRUG

Fingolimod 0.5 mg QD, oral

Also known as: FTY720

Fingolimod

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

RECRUITING

Novartis Investigative Site

Taichung, 407219, Taiwan

RECRUITING

Novartis Investigative Site

Tainan, 704302, Taiwan

WITHDRAWN

Novartis Investigative Site

Taipei, 10002, Taiwan

RECRUITING

Novartis Investigative Site

Taipei, 11220, Taiwan

WITHDRAWN

Novartis Investigative Site

Taoyuan District, 33305, Taiwan

WITHDRAWN

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 21, 2020
• Study Start: October 12, 2020
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

TW (6)