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

NCT04667949

CompletedPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Relapsing Multiple Sclerosis (RMS)

Interventions: Fingolimod 0.5mg

Countries: 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)

Eligibility overview

Sex: ALL

Age: 10 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (13)

Beijing, Beijing Municipality, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Suzhou, Jiangsu, China
Changchun, Jilin, China
Chengdu, Sichuan, China
Wenzhou, Zhejiang, China
Beijing, China
Beijing, China
Guangzhou, China
Shanghai, China