The study will assess the patients' satisfaction of treatment after 12 months treatment with fingolimod It also will assess the tolerability profile of fingolimod in a small population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
42
Fingolimod 0.5mg orally once a day without food.
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Bursa, Turkey, Turkey (Türkiye)
Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9)
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.
Time frame: Baseline and month 12
Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).
The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.
Time frame: Month 1
Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).
The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.
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Novartis Investigative Site
Izmir, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Altunizade, Turkey (Türkiye)
Novartis Investigative Site
Atakum / Samsun, Turkey (Türkiye)
Novartis Investigative Site
Fatih / Istanbul, Turkey (Türkiye)
Novartis Investigative Site
Kocaeli, Turkey (Türkiye)
Novartis Investigative Site
Mecidiyekoy/Istanbul, Turkey (Türkiye)
Novartis Investigative Site
Trabzon, Turkey (Türkiye)
...and 1 more locations
Time frame: Month 6
Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).
The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.
Time frame: Month 12