Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

  • STATUS
    Recruiting
  • End date
    Dec 28, 2024
  • participants needed
    100
  • sponsor
    Novartis Pharmaceuticals
Updated on 9 May 2021

Summary

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

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.

Details
Condition Relapsing Multiple Sclerosis
Treatment Fingolimod 0.5mg
Clinical Study IdentifierNCT04667949
SponsorNovartis Pharmaceuticals
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 10 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Relapsing Multiple Sclerosis??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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