Clinical trial NCT04667949: Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Multiple Sclerosis (RMS)
Keywords: Relapse Multiple Sclerosis (RMS)
Fingolimod
Adult
Pediatric
China
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-12-16
Enrollment: 98
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: This is 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) subjects in China.

The study will consist of three Phases:

Screening (up to 1 month): After signing informed consent, subjects will enter a Screening Phase to determine eligibility according to inclusion and exclusion criteria.

Treatment Period (24 months): On visit Day 1, all eligibility criteria will be confirmed, including a pre-dose ECG and vital signs. The first dose of study drug will be taken in the clinic on Day 1 and the subject will be monitored for 6 hours after the first dose administration before discharge. Participants will return to site for evaluation at month 1 and then every three months until the end of treatment up to 24 months.

Follow Up (2 months): Subjects who completed Treatment Period or discontinued from treatment will return for the Follow-up visit 2 months after the last dose of study drug.

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.

Primary outcomes:
measure: Change from baseline in Annualized relapse rate(ARR)
timeFrame: Baseline to Month 24
Secondary outcomes:
measure: The number of Adverse events (AE) and serious adverse events (SAE)
timeFrame: Baseline up to Month 26
measure: Change from baseline in T1 hypo-intense lesion volume
timeFrame: Baseline up to Month 24
measure: Change from baseline in T2 lesion volume
timeFrame: Baseline up to Month 24
measure: Change from baseline in Gd-enhancing T1 lesion volume
timeFrame: Baseline up to Month 24
measure: Change from baseline in number of T1 hypo-intense lesions
timeFrame: Baseline up to Month 24
measure: Change from baseline in number of new/newly enlarged T2 lesions
timeFrame: Baseline up to Month 24
measure: Change from baseline in number of Gd-enhancing T1 lesions
timeFrame: Baseline up to Month 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Zhengzhou
country: China
facility: Novartis Investigative Site
state: Henan
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Chang Chun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Wenzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Guang Zhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
Study officials:
References: