Clinical trial NCT06949956: Administration of Fingolimod in Greek Patients With Multiple Sclerosis.
Official title: Administration of Fingolimod in Greek Patients With Multiple Sclerosis for the Evaluation of the Efficacy and Safety, Based on the Standard Clinical Practice.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: RRMS
ARR
EDSS
Fingolimod
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
Collaborators: name: AHEPA University Hospital
First posted: 2025-04-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll patients with relapsing-remitting multiple sclerosis (RRMS) who are already receiving the active substance fingolimod.

Patients must have at least 12 months of follow-up data available prior to study entry, sufficient to calculate the annualized relapse rate.

No additional diagnostic or monitoring procedures will be required for patient participation in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years of age.
2. Consent and compliance of participants with the treatments and procedures of the study.
3. Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald 2017 criteria.
4. Patients who are receiving fingolimod, according to the drug's Summary of product Characteristics (SmPC).
5. 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:

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

Primary outcomes:
measure: Annualized Relapse Rate, ARR
timeFrame: 2 years
Secondary outcomes:
measure: Expanded Disability Status Scale, EDSS
timeFrame: 2 years
measure: Progression Independent of Relapse Activity, PIRA
timeFrame: 2 years
measure: Further calculation of Progression Independent of Relapse Activity (PIRA) taking into account clinical and imaging data (if available).
timeFrame: 2 years
measure: Quality of Life (QoL) of patients with multiple sclerosis.
timeFrame: 2 years
measure: Safety evaluation of the drug throughout the treatment period.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: AHEPA University Hospital of Thessaloniki, Greece
name: Nikolaos Grigoriadis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.
citation: Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, Robertson N, La Rocca N, Uitdehaag B, van der Mei I, Wallin M, Helme A, Angood Napier C, Rijke N, Baneke P. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec;26(14):1816-1821. doi: 10.1177/1352458520970841. Epub 2020 Nov 11.
citation: Bakirtzis C, Grigoriadou E, Boziki MK, Kesidou E, Siafis S, Moysiadis T, Tsakona D, Thireos E, Nikolaidis I, Pourzitaki C, Kouvelas D, Papazisis G, Tsalikakis D, Grigoriadis N. The Administrative Prevalence of Multiple Sclerosis in Greece on the Basis of a Nationwide Prescription Database. Front Neurol. 2020 Sep 29;11:1012. doi: 10.3389/fneur.2020.01012. eCollection 2020.