AG9827 SpA Extend 2024
Research type
Research Study
Full title
Clinical characteristics, treatment patterns and outcomes in patients with axSpA and PsA following initiation of bimekizumab, risankizumab, upadacitinib or a TNF inhibitor.
IRAS ID
345137
Contact name
William Tillet
Contact email
Sponsor organisation
Adelphi Real World
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is a non-interventional (participants are only observed, do not receive a medication as part of the study), multi-centre (approximately 15+ hospitals), prospective (information is collected at more than one timepoint) patient outcomes study combined with a retrospective medical chart review (where doctors or nurses look through a patient’s medical record). Study information will be collected for patients diagnosed with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) starting treatment with the drugs bimekizumab, upadacitinib, risankizumab or tumour necrosis factor-alpha inhibitors (e.g. adalimumab and etanercept). Staff at participating NHS Hospitals will complete chart reviews and report data recorded at consultations across the year following a patient beginning treatment with one of the previously mentioned drugs. Information of interest will cover topics such as a patient’s disease severity and response to the treatment. Across this same period participating patients will be asked to complete surveys asking about their experiences following the start of a new treatment. These short surveys (15 minutes long) will include validated patient-reported outcome measures (short questionnaires commonly used in research) that will assess the patient’s health-related quality of life and disease activity. These surveys will be completed by the patients every three months (as well one at 6-weeks) throughout the study period, on any electronic device with access to a web browser (e.g. a smartphone, tablet, laptop, or desktop computer). The information collected will allow us to investigate the effectiveness of different treatments in the year following them first being prescribed and understand the differences between different treatment options. This research study is organised and paid for by Adelphi Real World, a research organisation.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0332
Date of REC Opinion
10 Oct 2024
REC opinion
Further Information Favourable Opinion