Administration of Fingolimod in Greek Patients With Multiple Sclerosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Relapsing Remitting Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Primary outcome measures
- Annualized Relapse Rate, ARR [Time frame: 2 years]
Secondary outcome measures (5)
- Expanded Disability Status Scale, EDSS [Time frame: 2 years]
- Progression Independent of Relapse Activity, PIRA [Time frame: 2 years]
- Further calculation of Progression Independent of Relapse Activity (PIRA) taking into account clinical and imaging data (if available). [Time frame: 2 years]
- Quality of Life (QoL) of patients with multiple sclerosis. [Time frame: 2 years]
- Safety evaluation of the drug throughout the treatment period. [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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 mult PMID 24871874
- 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
- 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
Identifiers
NCT: NCT06949956 · 2021-FIN-EL-152