Administration of Fingolimod in Greek Patients With Multiple Sclerosis.
NCT ID: NCT06949956
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
140 participants
OBSERVATIONAL
2025-06-01
2027-12-31
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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AHEPA University Hospital
OTHER
Elpen Pharmaceutical Co. Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nikolaos Grigoriadis, MD
Role: PRINCIPAL_INVESTIGATOR
AHEPA University Hospital of Thessaloniki, Greece
Central Contacts
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References
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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.
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.
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.
Other Identifiers
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2021-FIN-EL-152
Identifier Type: -
Identifier Source: org_study_id
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