Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
RRMS, ARR, EDSS, Fingolimod
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.
Interventions
None listed
Sponsors
AHEPA University Hospital
Elpen Pharmaceutical Co. Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Progression Independent of Relapse Activity, PIRA | 2 years | Assessment of patients with Progression Independent of Relapse Activity (PIRA), through the roving EDSS method. |
| 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. |
Contacts
Primary ContactAlexandros Ginis, MD
Backup ContactPolyanthi Papanastasiou, MSc
Outcome results
None listed