CFTY720D2409: long-term fingolimod heart risk study
Research type
Research Study
Full title
Long-term, open-label, multicenter study assessing long-term cardiovascular risks in patients treated with fingolimod
IRAS ID
159486
Contact name
Stanislav Chevernozhenko
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
2014-001241-24, EUDRAT
Duration of Study in the UK
5 years, 2 months, 30 days
Research summary
Multiple Sclerosis (MS) is a common disabling disease of the Central Nervous System (brain and spinal cord) in adults. The focus of this study is a type of MS known as relapsing remitting MS (RRMS), where patients experience repeated episodes of neurological symptoms (relapses), which are followed by a complete or partial recovery (remission).
Fingolimod (FTY720/Gilenya) is a treatment for MS. It is taken once daily as a tablet that acts on white bloods cells responsible for immune reactions linked to MS. Previous studies with fingolimod showed a significant decrease in the number of relapses per patient.
The main purpose of this study is to complement an on-going fingolimod study called CFTY720D2406, which is regulatory mandated PASS observational study collecting long-term safety data on fingolimod use. This study, CFTY720D2409, will assess the long-term cardiovascular risk of fingolimod in those participants from CFTY720D2406 who experience a cardiovascular event during treatment start (or re-start), which leads to overnight monitoring and/or meets the protocol serious adverse event criteria. In addition to capturing information on routine procedures and care, the CFTY720D2409 study will have participants’ complete 6 monthly ECG and blood pressure cardiovascular assessments and a review of potential specific adverse events that are of particular interest to Novartis understanding of the fingolimod safety profile.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0148
Date of REC Opinion
31 Mar 2015
REC opinion
Favourable Opinion