Status:
COMPLETED
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Multiple Sclerosis (RMS)
Eligibility:
All Genders
10-65 years
Phase:
PHASE4
Brief Summary
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)
Detailed Description
This was 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) par...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2025
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04667949
Start Date
February 20 2021
End Date
March 25 2025
Last Update
November 25 2025
Active Locations (13)
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1
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100000
2
Novartis Investigative Site
Guangzhou, Guangdong, China, 510623
3
Novartis Investigative Site
Guangzhou, Guangdong, China, 510630
4
Novartis Investigative Site
Zhengzhou, Henan, China, 450052