Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis

NCT07724847 | Recruiting

• 1 other identifier: ChinaPLAGH-axSpA
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Spondyloarthritis (SpA); Chronic Back Pain; Axial Spondyloarthritis (AxSpA)

Keywords

Classification Criteria; Validation; Diagnostic Accuracy; ASAS-SPARTAN

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the 2025 ASAS-SPARTAN classification criteria for axial spondyloarthritis

  Sensitivity and specificity of the 2025 ASAS-SPARTAN revised classification criteria for diagnosing axial spondyloarthritis, compared against the clinician's gold-standard diagnosis based on comprehensive clinical, laboratory, and imaging assessments.

  At baseline (single assessment during index visit)

Secondary Outcomes (1)

• Concordance between 2025 ASAS-SPARTAN and 2009 ASAS classification criteria

  At baseline (single assessment during index visit)

Study Arms (1)

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.

Other: Diagnostic Assessment

Interventions

Diagnostic Assessment OTHER

Comprehensive diagnostic evaluation including clinical history, physical examination, laboratory tests (CBC, liver/renal function, HLA-B27, ESR, CRP), and imaging studies (pelvic X-ray, sacroiliac joint MRI/CT). No therapeutic intervention is provided as part of this study; all diagnostic and treatment decisions are made by clinicians according to standard clinical practice

Chronic Back Pain Patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic back pain (duration ≥3 months, onset age ≤45 years) who are suspected of having axial spondyloarthritis and present to rheumatology clinics for diagnostic evaluation. Participants must be willing to undergo comprehensive clinical, laboratory, and imaging assessments.

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Electric Power Hospital: collaborator
• The General Hospital of Central Theater Command: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

• Ez-Zaitouni Z, Bakker PAC, van Lunteren M, Berg IJ, Landewe R, van Oosterhout M, Lorenzin M, van der Heijde D, van Gaalen FA. Presence of multiple spondyloarthritis (SpA) features is important but not sufficient for a diagnosis of axial spondyloarthritis: data from the SPondyloArthritis Caught Early (SPACE) cohort. Ann Rheum Dis. 2017 Jun;76(6):1086-1092. doi: 10.1136/annrheumdis-2016-210119. Epub 2017 Jan 6.

  PMID: 28062405 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Jian Zhu

  Chinese PLA General Hospital, Department of Rheumatology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhu

CONTACT

13671105096; jian_jzhu@126.com

Jian Zhu

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)