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

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)

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.

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.