PROFILE Patient Reported Outcomes with Fingolimod V1.0
Research type
Research Study
Full title
Patient Reported Outcomes with Fingolimod in Local Experience - PROFILE
IRAS ID
155392
Contact name
Jane Watson
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Research summary
Gilenya (fingolimod 0.5mg) is a disease modifying therapy (DMT) for multiple sclerosis and was first granted a European licence in in 2011 and first approved for use in the UK National Health Service by the National Institute for Health and Care Excellence (NICE) in 2012. Evidence gathered from post-marketing experience with Gilenya suggests that treatment significantly impacts on quality of life. However, UK-specific data on quality of life, treatment adherence and satisfaction in patients treated with Gilenya in the real world setting is lacking and this study will provide these data.
This study is a multi-centre, prospective cohort, non-interventional study in upto 240 UK relapsing remitting multiple sclerosis patients. Patients will be selected by the study sites and assessed for eligibility in line with key inclusion criteria. Patients will undergo informed consent and the following initial study data will be collected if available - age, gender, date of diagnosis, past medical history, current medications and any disease modifying therapy treatment - at the time of screening for commencement with Gilenya therapy. Study assessments will occur at baseline, 3, 6 and 12 months and will consist of completion of four questionnaires. Each questionnaire is likely to take a maximum of 5 minutes to complete. A study site health care professional (HCP) will be asked to post out questionnaires to the participants at 3, 6 and 12 months. These will be completed by the patient and posted back to the study site. Questionnaires will be reviewed by the study site for any potential safety concerns.
REC name
London - Bromley Research Ethics Committee
REC reference
14/LO/1243
Date of REC Opinion
10 Jul 2014
REC opinion
Favourable Opinion