Administration of Fingolimod in Greek Patients With Multiple Sclerosis.

N/ANot Yet RecruitingNCT06949956

Elpen Pharmaceutical Co. Inc.140 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Relapsing Remitting Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Expanded Disability Status Scale, EDSS

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.

Time frame: 2 years

Progression Independent of Relapse Activity, PIRA

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

Time frame: 2 years

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

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).

Time frame: 2 years

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

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').

Time frame: 2 years

Safety evaluation of the drug throughout the treatment period.

Central Contacts

Alexandros Ginis, MD

CONTACT

003021011865734 a.ginis@elpen.gr

Polyanthi Papanastasiou, MSc

CONTACT

003021011865777 p.papanastasiou@elpen.gr

Data from ClinicalTrials.gov

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