Administration of Fingolimod in Greek Patients With Multiple Sclerosis.

NCT06949956 | Not Yet Recruiting

• 1 other identifier: 2021-FIN-EL-152
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

RRMS; ARR; EDSS; Fingolimod

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate, ARR

  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.

  2 years

Secondary Outcomes (5)

• Expanded Disability Status Scale, EDSS

  2 years

• Progression Independent of Relapse Activity, PIRA

  2 years

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

  2 years

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

  2 years

• Safety evaluation of the drug throughout the treatment period.

  2 years

Study Arms (1)

Multiple Sclerosis patients

Multiple Sclerosis patients already receiving fingolimod and who have available follow-up data for at least 12 months prior to study entry, sufficient to calculate the annualized relapse rate.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead
• AHEPA University Hospital: collaborator

Related Publications (3)

• 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.

  PMID: 24871874 BACKGROUND

• 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.

  PMID: 33174475 BACKGROUND

• 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.

  PMID: 33132996 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nikolaos Grigoriadis, MD

  AHEPA University Hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandros Ginis, MD

CONTACT

003021011865734; a.ginis@elpen.gr

Polyanthi Papanastasiou, MSc

CONTACT

003021011865777; p.papanastasiou@elpen.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: April 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share