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

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ClinicalTrials.gov Identifier: NCT04480853
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Fingolimod Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 12, 2020
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fingolimod
Open label Fingolimod 0.5 mg capsule taken once daily, oral.
Drug: Fingolimod
Fingolimod 0.5 mg QD, oral
Other Name: FTY720




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480853


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Taiwan
Novartis Investigative Site Recruiting
Kaoshiung, Taiwan, 83301
Novartis Investigative Site Recruiting
Taichung, Taiwan, 40705
Novartis Investigative Site Recruiting
Tainan, Taiwan, 70403
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10002
Novartis Investigative Site Recruiting
Taipei, Taiwan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04480853    
Other Study ID Numbers: CFTY720DTW03
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Fingolimod
Multiple sclerosis
Relapsing-remitting multiple sclerosis
Relapsing-remitting
Post-authorization study
Adult
MS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs