Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Mu… (NCT04667949) | Clinical Trial Compass
CompletedPhase 4
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
China98 participantsStarted 2021-02-20
Plain-language 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)
Who can participate
Age range10 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Adjusted Annualized Relapse Rate (ARR) in Adult Group