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Relapsing Multiple Sclerosis (RMS)Phase 4NCT04667949

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

A Phase 4 study testing Fingolimod 0.5mg in people with Relapsing Multiple Sclerosis (RMS), run by Novartis Pharmaceuticals at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 10 to 65 years
Conditions the study is for
Relapsing Multiple Sclerosis (RMS)
What is being tested?
Fingolimod 0.5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
13 sitesChina
Study dates
20 Feb 2021to 25 Mar 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100000

  • Novartis Investigative Site

    Beijing, 065001

  • Novartis Investigative Site

    Beijing, 100028

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510623

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630

  • Novartis Investigative Site

    Guangzhou, 510260

  • Novartis Investigative Site

    Shanghai, 200040

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

  • Novartis Investigative Site

    Zhengzhou, Henan, 450052

Other trials in China

About this study

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

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)

Read the detailed description

This was 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) participants in China.

The study consisted of three Phases:

  • Screening (up to 1 month): After signing informed consent, participants entered a Screening Phase to determine eligibility according to inclusion and exclusion criteria.
  • Treatment Period (24 months): On visit Day 1, all eligibility criteria were confirmed, including a pre-dose ECG and vital signs. The first dose of study drug was taken in the clinic on Day 1 and the participant was monitored for 6 hours after the first dose administration before discharge. Participants returned 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 returned for the Follow-up visit 2 months after the last dose of study drug.
Being tested
Fingolimod 0.5mg
Keywords
Relapsing Multiple Sclerosis (RMS), Fingolimod, Adult, Pediatric, China

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fingolimod 0.5mgDrug

    Also called FTY720

    Subjects received fingolimod 0.5mg capsule QD up to month 24

Study groups in NCT04667949
Study groupRoleWhat they receive
FingolimodExperimentalFingolimod 0.5 mg capsule taken orally once daily
Receives: Drug: Fingolimod 0.5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adjusted Annualized Relapse Rate (ARR) in Adult Group

    A confirmed relapse is any relapse that is accompanied by an increase of at least 0.5 on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS) as confirmed by the treating physician.

    The adjusted annualized relapse rate (ARR) was estimated by a negative binomial regression model with log-link function, the cumulative number of confirmed MS relapses per subject as the response variable, number of relapses in the previous two years before enrollment and baseline EDSS as continuous covariates. Natural log of time on study in years was used as the offset variable to account for the varying lengths of subjects' time in the study. The adjusted ARR (i.e.model-based estimate adjusted for covariates) and the corresponding 95% confidence interval were obtained.

    As per SAP this analysis was only performed for the Adult group. Descriptive data is presented in subsequent OMs.

    Measured: Baseline to Month 24

Secondary outcomes (9)

  1. Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE)

    An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject after providing written informed consent for participation in the study.

    For reporting purposes, the main focus was on treatment emergent adverse event (TEAE), defined as any AE which started on or after the day of first dose of study medication or events present prior to the start of treatment but increased in severity.

    Measured: From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months

  2. Annualized Rate of the Number of New or Newly Enlarged T2 Lesions

    Obtained from fitting a negative binomial regression model with log-link function, the total number of new or newly enlarged T2 lesions during the treatment period (per participant) as the response variable.

    The model included baseline age and volume of T2 lesions at baseline as continuous covariates. Natural log of time from screening scan in years was used as the offset.

    Baseline is defined as the last non-missing assessment obtained prior to the first administration of study drug. As per SAP this analysis was only performed for the Adult group.

    Measured: Baseline to end of treatment (up to Month 24)

  3. Change From Baseline in Number of New or Newly Enlarged T2 Lesions

    Number of new/newly enlarged T2 lesions since baseline as measured by MRI

    Measured: Baseline up to Month 24

  4. Change From Baseline in T2 Lesion Volume

    T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value

    Measured: Baseline up to Month 24

  5. Number of Gd-enhancing T1 Lesions Per Scan in Adult Group

    Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per patient) as the response variable.

    The model included baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans was used as the offset.

    MRI scans were performed at baseline, month 12 and month 24 and End of treatment for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. As per SAP this analysis was only performed for the Adult group.

    Measured: Baseline up to Month 24

  6. Number of Gd-enhancing T1 Lesions

    Number of Gd-enhancing T1 lesions as measured by MRI

    Measured: Baseline up to Month 24

  7. Change From Baseline in Gd-enhancing T1 Lesion Volume

    Gd-enhancing T1 lesion volume as measured by MRI and calculated as post-baseline value - baseline value

    Measured: Baseline up to Month 24

  8. Number of T1 Hypo-intense Lesions

    Number of T1 hypo-intense lesions as measured by MRI

    Measured: Baseline up to Month 24

  9. Change From Baseline in T1 Hypo-intense Lesion Volume

    T1 hypo-intense lesions as measured by MRI and calculated as post-baseline value - baseline value

    Measured: Baseline up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start20 Feb 2021
  3. Primary completion25 Mar 2025
  4. Study completion25 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04667949
Sponsor's protocol ID
CFTY720D2419
Other IDs
2024-000601-32
Status last verified
Dec 2025
First submitted
8 Dec 2020
Last updated
13 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fingolimod 0.5mg in people with Relapsing Multiple Sclerosis (RMS), run by Novartis Pharmaceuticals at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Annualized Relapse Rate (ARR) in Adult Group (time frame: Baseline to Month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04667949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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