Administration of Fingolimod in Greek Patients With Multiple Sclerosis.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Registration Number
- NCT06949956
- Lead Sponsor
- Elpen Pharmaceutical Co. Inc.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annualized Relapse Rate, ARR 2 years 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.
- Secondary Outcome Measures
Name Time Method Progression Independent of Relapse Activity, PIRA 2 years Assessment of patients with Progression Independent of Relapse Activity (PIRA), through the roving EDSS method.
Expanded Disability Status Scale, EDSS 2 years 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.
Further calculation of Progression Independent of Relapse Activity (PIRA) taking into account clinical and imaging data (if available). 2 years 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).
Quality of Life (QoL) of patients with multiple sclerosis. 2 years 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').
Safety evaluation of the drug throughout the treatment period. 2 years Recording of adverse events (AE) during treatment.