Administration of Fingolimod in Greek Patients With Multiple Sclerosis. (FILYRA)

ELPEN

Status: Not yet enrolling

Conditions: Relapsing Remitting Multiple Sclerosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06949956

2021-FIN-EL-152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

140 participants in 1 patient group

Multiple Sclerosis patients

Description:

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.