Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis (MVAS2025)
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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
Assessments:
- Clinical history and physical examination
- Laboratory tests: complete blood count, liver and renal function, HLA-B27, ESR, CRP
- Imaging: pelvic and whole-spine X-ray, sacroiliac joint MRI, sacroiliac joint CT; additional imaging (hip/spine MRI or CT, joint ultrasound, bone scan) as clinically indicated
Diagnostic Evaluation:
- Clinicians will establish a gold-standard diagnosis based on comprehensive clinical, laboratory, and imaging findings
- Both 2025 ASAS-SPARTAN and 2009 ASAS classification criteria will be applied to each patient
- Statistical analysis will evaluate sensitivity, specificity, and concordance between criteria
Sample Size: 247 patients (calculated using PASS 2021 software for one-sample sensitivity and specificity confidence intervals, based on expected sensitivity 75%, specificity 90%, and prevalence 0.7)
Statistical Methods:
- Continuous variables: mean ± standard deviation, independent sample t-test
- Categorical variables: relative frequencies, Chi-square test
- Multivariate logistic regression and Cox regression for prognostic factor analysis
- P < 0.05 considered statistically significant
Data Management:
- Standardized eCRF with defined variable definitions and coding rules
- Password-protected online data entry platform
- De-identification of personal information for publication and data sharing
- Compliance with GCP, Declaration of Helsinki, and Chinese regulatory requirements
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Jian Zhu
- Número de telefone: 13671105096
- E-mail: jian_jzhu@126.com
Estude backup de contato
- Nome: Jian Zhu
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- Recrutamento
- Chinese PLA General Hospital
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Contato:
- Jian Zhu, Professor
- Número de telefone: 13671105096
- E-mail: jian_jzhu@126.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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.
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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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Diagnostic accuracy of the 2025 ASAS-SPARTAN classification criteria for axial spondyloarthritis
Prazo: At baseline (single assessment during index visit)
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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.
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At baseline (single assessment during index visit)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Concordance between 2025 ASAS-SPARTAN and 2009 ASAS classification criteria
Prazo: At baseline (single assessment during index visit)
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Agreement rate (percentage of consistent diagnoses) between the 2025 ASAS-SPARTAN revised criteria and the 2009 ASAS classification criteria for axial spondyloarthritis, including analysis of reasons for discordant cases.
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At baseline (single assessment during index visit)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jian Zhu, Chinese PLA General Hospital, Department of Rheumatology and Immunology
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ChinaPLAGH-axSpA
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