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

Novartis

Status and phase

Completed

Phase 4

Conditions

Relapsing Multiple Sclerosis (RMS)

Treatments

Drug: Fingolimod 0.5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04667949

CFTY720D2419

Details and patient eligibility

About

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

Full 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.

Enrollment

98 patients

Sex

All

Ages

10 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant 10 to 17 years old inclusive with weight > 40kg.
Participant 18 to 65 years old inclusive;
Participants with relapsing multiple sclerosis
Participants never used fingolimod before enrollment
Subjects with Expanded Disability Status Scale (EDSS) score of 0 - 6.0 (inclusive) at Screening

Exclusion criteria

Participants with certain cardiovascular conditions and/or findings in the screening ECG.
Diagnosis of macular edema during screening visit.
Increased risk for opportunistic infections
Participants with known active malignancies.
Participants who have been treated with teriflunomide within 3.5 months prior to baseline, except if active washout.
Participants with severe active infections, active chronic infection.
Participants with severe liver impairment.
Pregnant confirmed by a positive pregnancy test or nursing (lactating) women.

Other protocol-specified inclusion or exclusion criteria may apply.