Ustekinumab Real World Evidence Study
Research type
Research Study
Full title
Ustekinumab Real World Evidence Study
IRAS ID
265870
Contact name
JR Fraser Cummings
Contact email
Sponsor organisation
University Hospital Southampton NHS Trust
Duration of Study in the UK
3 years, 9 months, 15 days
Research summary
Ustekinumab has been recently licensed for use in the management of Crohn's disease (CD) and approved by NICE. However, there is a paucity of real life outcomes data currently to inform decisions about its optimal use in clinical settings. This non-interventional clinical observational study aims to capture the experience of this new therapy across the UK. Any hospital in the UK will be eligible to participate in the study and all adult patients treated with ustekinumab will be eligible for the study. Patients will complete a number of simple questionnaires either at routine hospital visits or over the phone during their first 2 years of treatment. Teams will record data such as details of the patient's Crohn’s disease such as accurate characterisation of their disease, medications, previous history and blood tests that are taken part of the patients routine clinical data.
REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1369
Date of REC Opinion
3 Sep 2019
REC opinion
Favourable Opinion