MS Fine
Research type
Research Study
Full title
Patients with Multiple Sclerosis treated with Fingolimod:Real World UK Experience (MS Fine)
IRAS ID
155722
Contact name
Paula Pamies
Contact email
Sponsor organisation
Novartis Pharma Services AG
Clinicaltrials.gov Identifier
NEUR3512, CCRN Number
Duration of Study in the UK
0 years, 8 months, 17 days
Research summary
This is a multicentre, non interventional, retrospective study in the UK. A total of 300 patients will be included that have been initiated on fingolimod for at least 12 months. Informed consent will be required prior to collection of any clinical data.
This study does not impose a therapy protocol, diagnostic/therapeutic procedure, or a visit schedule. Patients will be treated according to routine medical practice in terms of visit frequency and types of assessments performed and only past data will be collected as part of the study.
All participants will have been initiated on fingolimod at least 12 months prior to being approached for consent for study participation. Data will be collected from all consenting eligible patients at the centres until the required sample size has been reached. Study data will be recorded on a paper CRF in anonymised-coded form.
The study observation period is for 12 months (±3 months) before and 12 months (±3 months) following initiation of fingolimod.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1190
Date of REC Opinion
21 Oct 2014
REC opinion
Favourable Opinion