Checking new criteria for axial spondyloarthritis in Chinese adults with chronic back pain
Tests new diagnostic criteria for axial spondyloarthritis in Chinese adults with chronic back pain.
Key facts
- Who runs it
- Chinese PLA General Hospital
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis
- Status
- Recruiting
- People taking part
- 247 people, planned
- Started
- 10 Apr 2026
- Expected to end
- 10 Apr 2027
- Type of study
- Observational
- Treatments tested
- Diagnostic Assessment
- Record updated
- 24 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting back pain that began at age 45 or younger and has no clear diagnosis yet. Everyone has tests to check how well new axial spondyloarthritis criteria work.
- Age
- 18 to 45 years
- Sex
- All sexes can join.
- Disease stage
- Back pain for 3 months or more, with no confirmed diagnosis. Back pain must have started at age 45 or younger.
Main reasons for not taking part
- Already diagnosed with axial spondyloarthritis, ankylosing spondylitis or another rheumatic disease
- Back pain for less than 3 months, or started after age 45
- A clearly diagnosed other cause of back pain, such as disc herniation, spinal stenosis, spinal tumour, spinal infection or osteoporotic fracture
- Cannot have the full tests, for example because of metal implants that prevent MRI
- Cannot communicate well enough to rate their own symptoms, or cannot give consent
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Where in China
- Chinese PLA General HospitalBeijing, ChinaContact: Jian Zhu, ProfessorTaking people
About the trial
What the trial wants to find out
This study aims to validate the 2025 ASAS-SPARTAN revised classification criteria for axial spondyloarthritis (axSpA) in the Chinese population through a multicenter, prospective, cross-sectional observational study.
Read full original descriptionShow less
Axial spondyloarthritis is a chronic inflammatory disease primarily affecting the spine and sacroiliac joints, causing back pain and stiffness. Early and accurate diagnosis is essential for timely treatment and improved patient outcomes. The 2025 ASAS-SPARTAN revised classification criteria were recently developed by the Assessment of SpondyloArthritis International Society (ASAS) and the SpondyloArthritis Research and Treatment Network (SPARTAN) to improve diagnostic accuracy and reduce over-diagnosis, with preset targets of sensitivity ≥75% and specificity ≥90%. However, the original validation study included only 71 Chinese patients out of 1,015 total participants, and racial differences in susceptibility genes, living environments, and socioeconomic-cultural backgrounds may affect the criteria's performance in Chinese patients.
This study will enroll patients with chronic back pain (CBP) lasting ≥3 months and onset age ≤45 years from multiple hospitals in China. All participants will undergo comprehensive diagnostic assessments including clinical history, physical examination, CRP testing, HLA-B27 testing, pelvic X-ray, and sacroiliac joint MRI. The 2025 ASAS-SPARTAN criteria will be applied to evaluate diagnostic performance, and results will be compared with the 2009 ASAS classification criteria and clinicians' gold-standard diagnoses.
The primary objective is to validate the sensitivity, specificity, and internal scoring rationality of the 2025 ASAS-SPARTAN criteria in Chinese axSpA patients. The secondary objective is to assess the concordance between the 2025 and 2009 ASAS criteria and analyze reasons for any discrepancies.
The findings will provide evidence for Chinese clinicians to select appropriate classification tools, reduce over-diagnosis of axSpA, and alleviate the burden on the healthcare system.
The group in the trial
- Chronic Back Pain Patients
Patients with chronic back pain (duration ≥3 months, onset age ≤45 years) who are suspected of having axial spondyloarthritis and undergo comprehensive diagnostic assessments including clinical evaluation, laboratory tests, and imaging studies.
Treatment: Diagnostic Assessment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis
- Plain-language title
- Checking new criteria for axial spondyloarthritis in Chinese adults with chronic back painGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07724847, who can take part
- Record updated
- 24 July 2026