NCT04667949CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 8 Dec 2020
- Start date
- 20 Feb 2021
- Primary completion date
- 25 Mar 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT04667949
- EudraCT number
- 2024-000601-32
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 98
- From 20 Feb 2021 to the primary completion date, 25 Mar 2025
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have been treated with teriflunomide within 3.5 months prior to baseline, except if active washout.
Other illness
- Participants with certain cardiovascular conditions and/or findings in the screening ECG.
- Increased risk for opportunistic infections
- Participants with known active malignancies.
- Participants with severe active infections, active chronic infection.
- Participants with severe liver impairment.
Other
- Diagnosis of macular edema during screening visit.
- Pregnant confirmed by a positive pregnancy test or nursing (lactating) women.
Who the study is looking for
- 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
Age in the registry: 10 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| - Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| - Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.