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NCT Number: NCT06949956

Administration of Fingolimod in Greek Patients With Multiple Sclerosis.

The goal of this observational study is to evaluate the efficacy of fingolimod through the estimation of the annualized relapse rate (ARR) over a period of 2 years.

Participants who are already taking fingolimod as part of their regular medical care for MS will answer questions about their medical history for the past 1 year and for their status for the next 2 years.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The efficacy of fingolimod will be assessed:

  • by calculating the difference in annualized relapse rate (ARR) between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment
  • by calculating the change in EDSS score between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age.
  • Consent and compliance of participants with the treatments and procedures of the study.
  • Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald 2017 criteria.
  • Patients who are receiving fingolimod, according to the drug's Summary of product Characteristics (SmPC).
  • Patients with available follow-up data for at least 12 months prior to their inclusion in the study, which are sufficient to calculate the annualized relapse rate.

Exclusion criteria

  • Patients under 18 years of age.
  • Patients with a contraindication to taking fingolimod according to the drug's Summary of product Characteristics (SmPC).
  • Patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study.
  • Patients participating in another research protocol.

Treatment and study plan

Primary outcomes

  1. Annualized Relapse Rate, ARR

    Time frame: 2 years

    The difference in the annualized relapse rate (ARR) between the twelve-month period prior to study entry and that which will occur during the study.

Secondary outcomes

  1. Expanded Disability Status Scale, EDSS

    Time frame: 2 years

    The change in Expanded Disability Status Scale (EDSS) score between the 12-month period before study entry and during the study. EDSS scale provides a score ranging from 0 to 10, where lower scores indicate less disability and higher scores indicate greater disability.

  2. Progression Independent of Relapse Activity, PIRA

    Time frame: 2 years

    Assessment of patients with Progression Independent of Relapse Activity (PIRA), through the roving EDSS method.

  3. Further calculation of Progression Independent of Relapse Activity (PIRA) taking into account clinical and imaging data (if available).

    Time frame: 2 years

    Further calculation of Progression Independent of Relapse Activity (PIRA) taking into account clinical data (SDMT, 9 Hole Peg-Test, Timed 25-Foot Walk tests) and imaging data (new/enlarging or enhancing lesions on Magnetic Resonance Imaging MRI, if available).

  4. Quality of Life (QoL) of patients with multiple sclerosis.

    Time frame: 2 years

    Evaluation of Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire scores at 0, 12 and 24 months of treatment. MusiQoL questionnaire have responses describing frequency/extent of an event on a five-point scale ranging from 'never/not at all' (option'1') to 'always/very much' (option '5').

  5. Safety evaluation of the drug throughout the treatment period.

    Time frame: 2 years

    Recording of adverse events (AE) during treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandros Ginis, MD

CONTACT

[email protected]

003021011865734

Polyanthi Papanastasiou, MSc

CONTACT

[email protected]

003021011865777

Sponsors and collaborators

Lead sponsor

Elpen Pharmaceutical Co. Inc.

Industry

Collaborators

  • AHEPA University Hospital

Registry information

Official study title

Administration of Fingolimod in Greek Patients With Multiple Sclerosis for the Evaluation of the Efficacy and Safety, Based on the Standard Clinical Practice.

Acronym: FILYRA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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