Administration of Fingolimod in Greek Patients With Multiple Sclerosis.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorElpen Pharmaceutical Co. Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
The study will enroll patients with relapsing-remitting multiple sclerosis (RRMS) who are already receiving the active substance fingolimod. Patients must have at least 12 months of follow-up data available prior to study entry, sufficient to calculate the annualized relapse rate. No additional diagnostic or monitoring procedures will be required for patient participation in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
140 Participants
are grouped into 1 trial groupGroup A: Multiple Sclerosis patients
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
Progression Independent of Relapse Activity, PIRA
Assessment of patients with Progression Independent of Relapse Activity (PIRA), through the roving EDSS method.
Time frame
2 years3
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 years4
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 yearsLocations
Sponsors and contacts
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Elpen Pharmaceutical Co. Inc.
Lead sponsor
AHEPA University Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: