Clinical Trials List
2020-07-15 - 2026-07-31
Phase IV
Not yet recruiting3
Recruiting3
ICD-10G35
Multiple sclerosis
ICD-9340
Multiple sclerosis
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)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chin-Chang Huang 未分科
- 張國軒 未分科
- 呂榮國 未分科
- 林信瓊 未分科
- Hong-Chou Kuo 未分科
- Yi-Hsin Weng 未分科
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 白晏瑋 無
- 周政達 未分科
- 黃金安、周政達、黃彥翔、梁巧盈 無
- 張婷雅 無
- 林念穎 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
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.
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 :
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.
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
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.
Inclution 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
The Estimated Number of Participants
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Taiwan
34 participants
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Global
0 participants
