Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

Relapsing Multiple Sclerosis (RMS) Clinical Trial

Official title: A 24-month, Open-label, Prospective, Multicenter Interventional, Single-arm Study Assessing the Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Relapsing Multiple Sclerosis (RMS) Patients in China

Status Active, not recruiting

Clinical Trial Summary

To assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing relapsing multiple sclerosis (RMS)

Clinical Trial Description

This is a 24-month, open-label, multicenter, interventional, single-arm study to collect efficacy and, safety of oral fingolimod 0.5 mg/day in approximately 100 relapsing multiple sclerosis (RMS) subjects in China. The study will consist of three Phases: Screening (up to 1 month): After signing informed consent, subjects will enter a Screening Phase to determine eligibility according to inclusion and exclusion criteria. Treatment Period (24 months): On visit Day 1, all eligibility criteria will be confirmed, including a pre-dose ECG and vital signs. The first dose of study drug will be taken in the clinic on Day 1 and the subject will be monitored for 6 hours after the first dose administration before discharge. Participants will return to site for evaluation at month 1 and then every three months until the end of treatment up to 24 months. Follow Up (2 months): Subjects who completed Treatment Period or discontinued from treatment will return for the Follow-up visit 2 months after the last dose of study drug. ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis (RMS)
• Sclerosis

• NCT number: NCT04667949
• Study type: Interventional
• Source: Novartis
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 20, 2021
• Completion date: March 28, 2025