Observational Study in SpA/ax-Spa patients treated with Bimekizumab
Research type
Research Study
Full title
Spondyloarthritis (Psoriatic Arthritis and Axial Spondyloarthritis) Patient-Centered Experience Initiating Bimekizumab in Routine Clinical Practice: A Multi-Country, Prospective, Observational Study (SPEAK)
IRAS ID
333184
Contact name
William Tillett
Contact email
Sponsor organisation
UCB BIOPHARMA SRL
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The overall aim of this observational study is to evaluate Patient Reported Outcomes (PROs), including Health-related Quality of Life (HRQoL), and to describe characteristics of psoriatic arthritis (PsA) and axial spondylitis (axSpA) (nonradiographic [nr]-axSpA and radiographic [r]-axSpA) patients following bimekizumab treatment initiation over time in routine clinical practice.
To improve medical care continuously, it is thus very important to collect further data on the use of a drug outside of regulated clinical trials.
The purpose of this study is
• to observe how Bimekizumab is used in routine clinical practice
• to learn what the experiences of patient are with Bimekizumab in terms of their health-related quality of life
• to evaluate whether there are any changes in the level of disease activity
• to characterize patients with PsA and r-/nr-axSpA in greater detail.There will be no study-specific assessments or clinical appointments, and patients will be treated in the usual way. Patients will be asked to electronically complete some questionnaires regarding the severity of their disease and how the symptoms might affect their life (health-related quality of life).
The trial is a multi-centre taking place in 10 sites in the UK with the aim to recruit 100 patients. The trial will take place over a period of 2.5 years.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0353
Date of REC Opinion
4 Dec 2023
REC opinion
Further Information Favourable Opinion