Safety and Efficacy of Fingolimod in MS Patients in China

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China

Official Title
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A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis (Relapsing Remitting)

Intervention / Treatment
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* Drug: fingolimod
* Drug: Placebo (6mos) + open label fingolimod (6 mos)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients must have relapsing remitting multiple sclerosis Exclusion Criteria: Patients with: History of chronic immune disease Certain cancers Uncontrolled diabetes Certain eye disorders -Negative for varicella zoster virus IgG antibodies Certain hepatic conditions Low white blood cell count On certain immunosuppressive medications or heart medications Certain heart conditions or certain lung conditions Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica. Other protocol defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: double blinded Fingolimod 6 mos + open label fingolimod 6 mos<br>Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily | Drug: fingolimod<br>* Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily<br>|
| Placebo Comparator: Placebo 6 mos + open label fingolimod 6 mos<br>Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily | Drug: Placebo (6mos) + open label fingolimod (6 mos)<br>* Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of new/newly enlarged T2 MRI lesions over 6 months | Cumulative number of new/newly enlarged T2 lesions over 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annualized relapse rate (ARR) | The annualized relapse rate (ARR) is identified as the average number of confirmed relapses per year (the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses will include all the confirmed relapses during the study. The time spent in the study will correspond to the observation period for all the relapses from first dose on the study drug to end of study. | 6 months | 
| number of Gd-enhancing T1 lesions |  | 6 months | 
| Safety and tolerability of fingolimod 0.5 mg compared to placebo | Based on frequency of adverse events (the number and percentage of patients having any AE by primary system organ class and preferred term) and on the incidence of clinically notable abnormalities | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis (MS), relapsing remitting multiple sclerosis (RRMS), fingolimod