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

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 98

Inclusion Criteria

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in Annualized relapse rate(ARR)

Secondary Outcome Measures

Name	Time	Method
The number of Adverse events (AE) and serious adverse events (SAE);Change from baseline in T1 hypo-intense lesion volume;Change from baseline in T2 lesion-new/newly enhancing lesion volume;Change from baseline in Gd-enhancing T1 lesion volume;Change from baseline in number of T1 hypo-intense lesions;Change from baseline in number of T2 lesions-new/newly enhancing lesions;Change from baseline in number of Gd-enhancing T1 lesions

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Recruitment & Eligibility

Study & Design

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