British Axial Spondyloarthritis Study for Newly Diagnosed Patients Aged 16 to 50
Tracking Disease Impact and Treatment Outcomes in the UK
Led by The Leeds Teaching Hospitals NHS Trust · Updated on 2023-07-18
500
Participants Needed
1
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying axial spondyloarthritis axSpA, a group of chronic rheumatic diseases causing inflammation in the spine. This study aims to understand how delays in diagnosis affect work ability and daily function, as well as the natural course of newly diagnosed axSpA patients in the UK. It also explores disease activity, pain, fatigue, treatments, and related conditions over time in people who have not yet used biologic therapy. The study is a prospective cohort that began in January 2023 and will run initially for three years, supported by Pfizer, UCB, and Novartis.
Participants will be followed remotely without any active treatment from the study team, meaning no intervention is given as part of the research. Data will be collected through participant reports and linking to health records. The study includes people newly diagnosed with axSpA within the last six months, aged 16 to 50 years, who have not started biologic therapy. This observational design allows researchers to track real-world outcomes over time.
During the study, participants will provide information on their work productivity and daily activities, with a key measure collected at baseline and 12 months. Quality of life related to ankylosing spondylitis will be assessed at 24 months. The study also monitors symptoms like pain and fatigue, and gathers data on treatments and comorbidities. This long-term follow-up helps improve understanding of axSpAs impact and outcomes in everyday clinical settings.
CONDITIONS
Brief Title
British Axial Spondyloarthritis Inception Cohort
Research Team
H
Helena Marzo-Ortega, MD/PhD
S
Sayyora Alieva
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Diagnosed with axial spondyloarthritis including ankylosing spondylitis within the last 6 months
Able and willing to give informed consent to participate
You will not qualify if you...
Younger than 16 years old
Unable to communicate in English or otherwise unable to give informed consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 36 months
Participants with axial spondyloarthritis are observed over time to evaluate diagnosis delays, work productivity, quality of life, and disease outcomes without receiving any intervention.
Remote follow-up visits via participants and data record linkage
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
British Axial Spondyloarthritis Inception Cohort (BAxSIC): a protocol for a multicentre real-world observational cohort study of early axial spondyloarthritis.
Jake Weddell, Stephanie R Harrison, Alexander N Bennett...