Observational study on newly diagnosed axial spondyloarthritis in the UK
British Axial Spondyloarthritis Inception Cohort
This study looks at how being diagnosed later with axial spondyloarthritis affects work and daily life for people in the UK who have just been diagnosed and haven’t started biologic treatment yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | The Leeds Teaching Hospitals NHS Trust Academic / other |
| Locations | 1 site (Leeds) |
| Trial ID | NCT05676775 on ClinicalTrials.gov |
What this trial studies
The British Axial Spondyloarthritis Inception Cohort (BAxSIC) aims to gather real-world data on the impact of delayed diagnosis of axial spondyloarthritis (axSpA) on work participation and functional outcomes. This prospective cohort study will enroll patients who have been newly diagnosed with axSpA and are naïve to biologic therapy, assessing various factors such as disease activity, pain, fatigue, and comorbidities over an initial three-year period. The study is conducted in collaboration with the British Society for Spondyloarthritis and the National Axial Spondyloarthritis Society, focusing on patients attending rheumatology clinics in the UK.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 and older who have received a physician diagnosis of axSpA within the last six months.
Not a fit: Patients under 16 years of age or those unable to communicate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve diagnosis and management of axial spondyloarthritis, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have shown success in utilizing real-world data to evaluate the impact of delayed diagnosis in similar conditions, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged ≥16 years. 2. A physician diagnosis of axSpA (including ankylosing spondylitis) within the last 6 months prior to baseline. 3. Willing and able to give informed consent to participate in the study. Exclusion Criteria: 1. Age \<16 years. 2. Unable to communicate in English or are deemed, in any other way, to be unable to give informed consent
Where this trial is running
Leeds
- Chapel Allerton Hospital — Leeds, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Helena Marzo-Ortega, MD/PhD — Leeds Teaching Hospital Trust
- Study coordinator: Helena Marzo-Ortega, MD/PhD
- Email: h.marzo-ortega@leeds.ac.uk
- Phone: +44 113 3924848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.