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

ClinicalTrials.gov Identifier: NCT04667949

Novartis Reference Number: CFTY720D2419

Last Update: Feb 04, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Relapsing Multiple Sclerosis (RMS)
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Feb 20, 2021
Completion date 
Dec 28, 2024
Gender 
All
Age(s)
10 Years - 65 Years (Child, Adult, Older Adult)

Interventions

Drug
Fingolimod 0.5mg
Subjects will receive fingolimod 0.5mg capsule QD up to month 24

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.

Other protocol-specified inclusion or exclusion criteria may apply.

Study Locations

China
Novartis Investigative Site
Recruiting
Beijing, 100000
Beijing
China
Novartis Investigative Site
Recruiting
Beijing,
Beijing
China
Novartis Investigative Site
Recruiting
Guangzhou, 510623
Guangdong
China
Novartis Investigative Site
Recruiting
Guangzhou, 510630
Guangdong
China
Novartis Investigative Site
Recruiting
Zhengzhou, 450052
Henan
China
Novartis Investigative Site
Recruiting
Wuhan, 430030
Hubei
China
Novartis Investigative Site
Recruiting
Suzhou, 215004
Jiangsu
China
Novartis Investigative Site
Recruiting
Changchun, 130021
Jilin
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
Recruiting
Wenzhou, 325000
Zhejiang
China
Novartis Investigative Site
Recruiting
Beijing, 100028
-
China
Novartis Investigative Site
Recruiting
Guang Zhou, 510260
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200040
-
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]