Fingolimod for Relapsing Multiple Sclerosis in Chinese Patients
This study aims to assess the effectiveness of Fingolimod in reducing relapse rates among Chinese patients with relapsing multiple sclerosis.
Fingolimod 0.5mg
Treatment Study
Summary
Study start date: February 20, 2021
Actual date on which the first participant was enrolled.This study is focused on evaluating the effectiveness and safety of a medication called Fingolimod, also known as Gilenya, for people with relapsing multiple sclerosis (RMS) in China. RMS is a form of multiple sclerosis where symptoms flare up or get worse over time. About 100 participants are involved in this research to see if taking 0.5 mg of Gilenya daily can help manage their condition. The importance of this study lies in its potential to offer better treatment options and improve the quality of life for those affected by RMS. Participants in the study first go through a screening process to ensure they meet all necessary criteria to join. Once accepted, they begin a 24-month treatment phase where they take the medication orally, starting with a monitored dose in the clinic. Their health and progress are checked regularly, with visits scheduled every three months. The primary goal is to measure how often participants experience relapses of their symptoms, using specific medical criteria to assess any changes. After completing the treatment phase, there is a follow-up period of two months to monitor any lasting effects of the medication. This structured approach helps researchers understand both the benefits and any potential risks associated with Gilenya.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.98 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 10 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Novartis Investigative Site
Guangzhou, ChinaNovartis Investigative Site
Guangzhou, ChinaNovartis Investigative Site
Zhengzhou, China