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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Fingolimod 0.5 mg QD, oral
Novartis Investigative Site
Kaohsiung City, Taiwan
RECRUITINGNovartis Investigative Site
Taichung, Taiwan
RECRUITINGNovartis Investigative Site
Tainan, Taiwan
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.
Time frame: 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).
Time frame: Baseline up to 12 months
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.
Time frame: Baseline up to 12 months
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
Time frame: Baseline up to 12 months
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.
Novartis Pharmaceuticals
CONTACT
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Novartis Investigative Site
Taipei, Taiwan
RECRUITINGNovartis Investigative Site
Taipei, Taiwan
WITHDRAWNNovartis Investigative Site
Taoyuan District, Taiwan
WITHDRAWNTime frame: Baseline up to 12 months