Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis (MVAS2025)
21 de julio de 2026 actualizado por: Jian Zhu, 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 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.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 estudio
Tipo de estudio
De observación
Inscripción (Estimado)
Inscripción
247
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Jian Zhu
- Número de teléfono: 13671105096
- Correo electrónico: jian_jzhu@126.com
Copia de seguridad de contactos de estudio
- Nombre: Jian Zhu
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100853
- Reclutamiento
- Chinese PLA General Hospital
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Contacto:
- Jian Zhu, Professor
- Número de teléfono: 13671105096
- Correo electrónico: jian_jzhu@126.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
1
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic accuracy of the 2025 ASAS-SPARTAN classification criteria for axial spondyloarthritis
Periodo de tiempo: 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 resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concordance between 2025 ASAS-SPARTAN and 2009 ASAS classification criteria
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Jian Zhu, Chinese PLA General Hospital, Department of Rheumatology and Immunology
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
10 de abril de 2026
Finalización primaria (Estimado)
Finalización primaria
10 de abril de 2027
Finalización del estudio (Estimado)
Finalización del estudio
10 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
21 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
24 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
24 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- ChinaPLAGH-axSpA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be made available outside the research team.
This decision is based on institutional data management policies, requirements for protection of patient privacy and personal information under Chinese regulations, and compliance with national laws governing human genetic resources.
De-identified aggregate data and study results will be published in peer-reviewed journals and presented at scientific conferences.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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