NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Administration of Fingolimod in Greek Patients With Multiple Sclerosis.

Not Yet RecruitingN/A

Sponsor: Elpen Pharmaceutical Co. Inc.

Conditions: Relapsing Remitting Multiple Sclerosis

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.