Validation of the 2025 Axial Spondyloarthritis Classification Criteria in Chinese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective cross-sectional study enlists adults with chronic back pain to see if the 2025 ASAS-SPARTAN criteria accurately identify axial spondyloarthritis. Clinicians will apply both the 2025 SPARTAN criteria and the 2009 criteria to every participant and compare results against a gold-standard diagnosis based on comprehensive clinical, lab, and imaging data. Data are collected with standardized electronic forms across four Chinese hospitals, with no experimental treatment and decisions made per usual clinical practice. The study aims to estimate sensitivity, specificity, and concordance between criteria to validate the revised classification approach in a Chinese population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Presence of current chronic back pain with duration ≥3 months and without a definitive diagnosis 2. Age at onset of back pain ≤45 years 3. Presentation to a rheumatologist for evaluation of suspected axial spondyloarthritis or related conditions, without a confirmed diagnosis of axSpA or other rheumatic diseases 4. Willingness to complete comprehensive diagnostic assessments including clinical history, physical examination, CRP testing, HLA-B27 testing, pelvic X-ray, and sacroiliac joint MRI (recent imaging may be acceptable if completed within appropriate timeframe) 5. Voluntary participation with provision of signed electronic informed consent

Exclusion Criteria:

* 1\. Inability to communicate due to cognitive impairment, visual impairment, or other factors affecting self-assessment 2. Confirmed diagnosis of axial spondyloarthritis (axSpA), ankylosing spondylitis (AS), or other established rheumatic diseases (e.g., rheumatoid arthritis, psoriatic arthritis) 3. Back pain duration \<3 months or age at onset \>45 years 4. Refusal or inability to complete full diagnostic evaluation due to medical contraindications (e.g., metallic implants preventing MRI, severe hepatic or renal dysfunction precluding laboratory testing) 5. Presence of clearly identified non-SpA causes of chronic back pain with established diagnosis, including lumbar disc herniation, spinal stenosis, spinal tumors, infectious spondylitis, or osteoporotic fractures 6. Failure to provide informed consent, inability to cooperate with study follow-up, or inability to provide complete data

Where it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jian Zhu — Chinese PLA General Hospital, Department of Rheumatology and Immunology
• Study coordinator: Jian Zhu
• Email: jian_jzhu@126.com
• Phone: 13671105096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.