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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Relapsing Multiple Sclerosis (RMS)

Intervention / Treatment
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* Drug: Fingolimod 0.5mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fingolimod<br>Fingolimod 0.5 mg capsule taken orally once daily | Drug: Fingolimod 0.5mg<br>* Subjects will receive fingolimod 0.5mg capsule QD up to month 24<br>* Other names: FTY720;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Annualized relapse rate(ARR) | A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A confirmed relapse by Treating Physician must be confirmed within 7 days of onset of symptoms and accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS.The EDSS is an ordinal scale used for assessing neurologic impairment based on an exam consisting of seven functional systems (FSs)which are scored from 0 to 10 (death from MS) and an ambulation score that are combined to determine the EDSS steps. The higher score means the worsening of neurological status. | Baseline to Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of Adverse events (AE) and serious adverse events (SAE) | Adverse events will be collected at each visit throughout the trial including a 2 month follow up period. Results from safety assessments may be recorded as adverse events if determined by the investigator to meet requirements of clinical significance and meeting definition of adverse event | Baseline up to Month 26 | 
| Change from baseline in T1 hypo-intense lesion volume | T1 hypo-intense lesions as measured by Magnetic Resonance Imaging (MRI) | Baseline up to Month 24 | 
| Change from baseline in T2 lesion-new/newly enhancing lesion volume | T2 lesion-new/newly enhancing lesions as measured by MRI | Baseline up to Month 24 | 
| Change from baseline in Gd-enhancing T1 lesion volume | Gd-enhancing T1 lesions as measured by MRI | Baseline up to Month 24 | 
| Change from baseline in number of T1 hypo-intense lesions | Number of T1 hypo-intense lesions as measured by MRI | Baseline up to Month 24 | 
| Change from baseline in number of T2 lesions-new/newly enhancing lesions | Number of T2 lesions-new/newly enhancing lesions as measured by MRI | Baseline up to Month 24 | 
| Change from baseline in number of Gd-enhancing T1 lesions | Number of Gd-enhancing T1 lesions as measured by MRI | Baseline up to Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse Multiple Sclerosis (RMS), Fingolimod, Adult, Pediatric, China