RWE of bimekizumab in axial spondyloarthritis
Research type
Research Study
Full title
Real-world impact of bimekizumab on disease activity in axial spondyloarthritis patients including the early subpopulation (EXPEDITE)(RWE0973/SPA002)
IRAS ID
354551
Contact name
Helen Marzo-Ortega
Contact email
Sponsor organisation
UCB Biosciences Inc.
Duration of Study in the UK
3 years, 8 months, 31 days
Research summary
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton (chest, spine, pelvis), causing pain, stiffness and inflammation in these areas. This is an observational study investigating the real world impact of bimekizumab on disease activity in patients diagnosed with axSpA who are prescribed bimekizumab as part of routine clinical practice.
Bimekizumab is an antibody drug which inhibits specific interleukins that are key contributors to inflammation in the body. Previous trials have demonstrated its effectiveness at reducing inflammation as compared to a placebo (sugar pill).
In this trial, patients prescribed Bimekizumab as part of routine clinical practice will have disease symptoms and manifestations assessed over a 52 week treatment period in patients with axSpA. The study will consider patients who have different times of disease onset. At each visit, patients will be asked about their axSpA symptoms to assess whether these are impacted by Bimekizumab. These visits will occur as part of a standard of care treatment plan and will not be affected by this trial protocol. The study will end when the final patient has completed the 52 week observation period and attended their last visit.
The primary aim is to evaluate the impact of Bimekizumab on disease activity, as measured by pain, stiffness and swollen fingers assessment at 52 weeks treatment in all axSpA patients. The study aims to recruit 1000 patients.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0074
Date of REC Opinion
2 Apr 2025
REC opinion
Favourable Opinion