Condition: Axial Spondyloarthritis (AxSpA) · Spondyloarthritis (SpA) · Chronic Back Pain · Sponsor: Chinese PLA General Hospital
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 w…
This description comes directly from the study's public registry record.
Jian Zhu · 13671105096 · jian_jzhu@126.com
Jian Zhu
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| Chinese PLA General Hospital | Beijing, Beijing Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07724847