Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the 2025 ASAS-SPARTAN classification criteria for axial spondyloarthritis
研究概览
简要总结
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.
详细描述
This is a multicenter, observational, cross-sectional study conducted across 4 hospitals in China, led by the Department of Rheumatology and Immunology at Chinese PLA General Hospital (First Medical Center).
Study Design:
- Prospective enrollment of eligible patients over 12 months
- No intervention; all diagnostic and treatment decisions are made by clinicians based on clinical judgment
- Data collection through standardized electronic case report forms (eCRF) using EpiData platform
Study Population:
- Adults with chronic back pain (CBP) duration ≥3 months
- Back pain onset age ≤45 years
- Patients presenting to rheumatologists without confirmed diagnosis of axSpA, AS, or other rheumatic diseases
- Patients willing to complete full diagnostic assessments and provide informed consent
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Presence of current chronic back pain with duration ≥3 months and without a definitive diagnosis
- •Age at onset of back pain ≤45 years
- •Presentation to a rheumatologist for evaluation of suspected axial spondyloarthritis or related conditions, without a confirmed diagnosis of axSpA or other rheumatic diseases
- •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)
- •Voluntary participation with provision of signed electronic informed consent
排除标准
- •1. Inability to communicate due to cognitive impairment, visual impairment, or other factors affecting self-assessment
- •Confirmed diagnosis of axial spondyloarthritis (axSpA), ankylosing spondylitis (AS), or other established rheumatic diseases (e.g., rheumatoid arthritis, psoriatic arthritis)
- •Back pain duration <3 months or age at onset >45 years
- •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)
- •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
- •Failure to provide informed consent, inability to cooperate with study follow-up, or inability to provide complete data
结局指标
主要结局
Diagnostic accuracy of the 2025 ASAS-SPARTAN classification criteria for axial spondyloarthritis
时间窗: At baseline (single assessment during index visit)
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.
次要结局
- Concordance between 2025 ASAS-SPARTAN and 2009 ASAS classification criteria(At baseline (single assessment during index visit))
研究者
Jian Zhu
Professor and Chief Physician
Chinese PLA General Hospital