NCT04667949

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

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: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study was to assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing multiple sclerosis (RMS)

Detailed description

This was 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) participants in China. The study consisted of three Phases: * Screening (up to 1 month): After signing informed consent, participants entered a Screening Phase to determine eligibility according to inclusion and exclusion criteria. * Treatment Period (24 months): On visit Day 1, all eligibility criteria were confirmed, including a pre-dose ECG and vital signs. The first dose of study drug was taken in the clinic on Day 1 and the participant was monitored for 6 hours after the first dose administration before discharge. Participants returned 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 returned for the Follow-up visit 2 months after the last dose of study drug.

Conditions

• Relapsing Multiple Sclerosis (RMS)

Interventions

Type	Name	Description
DRUG	Fingolimod 0.5mg	Subjects received fingolimod 0.5mg capsule QD up to month 24

Timeline

• Start date: 2021-02-20
• Primary completion: 2025-03-25
• Completion: 2025-03-25
• First posted: 2020-12-16
• Last updated: 2026-01-13
• Results posted: 2025-08-29

Locations

13 sites across 1 country: China