Actively Recruiting

Age: 16Years - 50Years
All Genders
ID05676775

British Axial Spondyloarthritis Inception Cohort Study to Evaluate Diagnosis Delays and Outcomes in Newly Diagnosed Patients

Led by The Leeds Teaching Hospitals NHS Trust · Updated on 2023-07-18

500

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

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 axSpA's impact and outcomes in everyday clinical settings.

CONDITIONS

Brief Title

British Axial Spondyloarthritis Inception Cohort

Who Can Participate

Age: 16Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 16 years or older
  • Diagnosed with axial spondyloarthritis including ankylosing spondylitis within the last 6 months
  • Able and willing to give informed consent to participate
Not Eligible

You will not qualify if you...

  • Younger than 16 years old
  • Unable to communicate in English or otherwise unable to give informed consent

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 1 location

1

Chapel Allerton Hospital

Leeds, United Kingdom, LS7 4SA

Actively Recruiting

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Research Team

H

Helena Marzo-Ortega, MD/PhD

S

Sayyora Alieva

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...

https://pubmed.ncbi.nlm.nih.gov/39165398