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

Primary Purpose

Relapsing Multiple Sclerosis (RMS)

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fingolimod 0.5mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis (RMS) focused on measuring Relapse Multiple Sclerosis (RMS), Fingolimod, Adult, Pediatric, China

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fingolimod

Arm Description

Fingolimod 0.5 mg capsule taken orally once daily

Outcomes

Primary Outcome Measures

Change from baseline in Annualized relapse rate(ARR)
A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A confirmed relapse by Treating Physician must be confirmed within 7 days of onset of symptoms and accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS.The EDSS is an ordinal scale used for assessing neurologic impairment based on an exam consisting of seven functional systems (FSs)which are scored from 0 to 10 (death from MS) and an ambulation score that are combined to determine the EDSS steps. The higher score means the worsening of neurological status.

Secondary Outcome Measures

The number of Adverse events (AE) and serious adverse events (SAE)
Adverse events will be collected at each visit throughout the trial including a 2 month follow up period. Results from safety assessments may be recorded as adverse events if determined by the investigator to meet requirements of clinical significance and meeting definition of adverse event
Change from baseline in T1 hypo-intense lesion volume
T1 hypo-intense lesions as measured by Magnetic Resonance Imaging (MRI)
Change from baseline in T2 lesion-new/newly enhancing lesion volume
T2 lesion-new/newly enhancing lesions as measured by MRI
Change from baseline in Gd-enhancing T1 lesion volume
Gd-enhancing T1 lesions as measured by MRI
Change from baseline in number of T1 hypo-intense lesions
Number of T1 hypo-intense lesions as measured by MRI
Change from baseline in number of T2 lesions-new/newly enhancing lesions
Number of T2 lesions-new/newly enhancing lesions as measured by MRI
Change from baseline in number of Gd-enhancing T1 lesions
Number of Gd-enhancing T1 lesions as measured by MRI

Full Information

First Posted
December 8, 2020
Last Updated
September 29, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04667949
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
March 28, 2025 (Anticipated)
Study Completion Date
March 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis (RMS)
Keywords
Relapse Multiple Sclerosis (RMS), Fingolimod, Adult, Pediatric, China

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fingolimod
Arm Type
Experimental
Arm Description
Fingolimod 0.5 mg capsule taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Fingolimod 0.5mg
Other Intervention Name(s)
FTY720
Intervention Description
Subjects will receive fingolimod 0.5mg capsule QD up to month 24
Primary Outcome Measure Information:
Title
Change from baseline in Annualized relapse rate(ARR)
Description
A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A confirmed relapse by Treating Physician must be confirmed within 7 days of onset of symptoms and accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS.The EDSS is an ordinal scale used for assessing neurologic impairment based on an exam consisting of seven functional systems (FSs)which are scored from 0 to 10 (death from MS) and an ambulation score that are combined to determine the EDSS steps. The higher score means the worsening of neurological status.
Time Frame
Baseline to Month 24
Secondary Outcome Measure Information:
Title
The number of Adverse events (AE) and serious adverse events (SAE)
Description
Adverse events will be collected at each visit throughout the trial including a 2 month follow up period. Results from safety assessments may be recorded as adverse events if determined by the investigator to meet requirements of clinical significance and meeting definition of adverse event
Time Frame
Baseline up to Month 26
Title
Change from baseline in T1 hypo-intense lesion volume
Description
T1 hypo-intense lesions as measured by Magnetic Resonance Imaging (MRI)
Time Frame
Baseline up to Month 24
Title
Change from baseline in T2 lesion-new/newly enhancing lesion volume
Description
T2 lesion-new/newly enhancing lesions as measured by MRI
Time Frame
Baseline up to Month 24
Title
Change from baseline in Gd-enhancing T1 lesion volume
Description
Gd-enhancing T1 lesions as measured by MRI
Time Frame
Baseline up to Month 24
Title
Change from baseline in number of T1 hypo-intense lesions
Description
Number of T1 hypo-intense lesions as measured by MRI
Time Frame
Baseline up to Month 24
Title
Change from baseline in number of T2 lesions-new/newly enhancing lesions
Description
Number of T2 lesions-new/newly enhancing lesions as measured by MRI
Time Frame
Baseline up to Month 24
Title
Change from baseline in number of Gd-enhancing T1 lesions
Description
Number of Gd-enhancing T1 lesions as measured by MRI
Time Frame
Baseline up to Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
065001
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510623
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Novartis Investigative Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Novartis Investigative Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Novartis Investigative Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Novartis Investigative Site
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100028
Country
China
Facility Name
Novartis Investigative Site
City
Guang Zhou
ZIP/Postal Code
510260
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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