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

Primary Purpose

Multiple Sclerosis

Status

Recruiting

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Fingolimod

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Fingolimod, Multiple sclerosis, Relapsing-remitting multiple sclerosis, Relapsing-remitting, Post-authorization study, Adult, MS

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fingolimod

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

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.

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

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.

Full Information

NCT ID

NCT04480853

First Posted

July 17, 2020

Last Updated

July 13, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04480853

Brief Title

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

Acronym

SPRING

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 12, 2020 (Actual)

Primary Completion Date

February 28, 2025 (Anticipated)

Study Completion Date

February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fingolimod

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fingolimod

Other Intervention Name(s)

FTY720

Intervention Description

Fingolimod 0.5 mg QD, oral

Primary Outcome Measure Information:

Title

Number of Adverse Events of Special Interest(AESI)

Description

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

Time Frame

First Dose Observation on the first day of taking findolimod

Title

Number of Adverse Events of Special Interest (AESI)

Description

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).

Time Frame

Baseline up to 12 months

Secondary Outcome Measure Information:

Title

Annualized relapse reate (ARR)

Description

Time Frame

Baseline up to 12 months

Title

Change from baseline of Pulse (beats/min)

Description

Time Frame

Baseline up to 12 months

Title

Change from baseline of blood pressure (mmHg)

Description

Time Frame

Baseline up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Kaoshiung

ZIP/Postal Code

83301

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11220

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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