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Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis (MVAS2025)

21 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

247

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Jian Zhu

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100853
        • Reclutamento
        • Chinese PLA General Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: Diagnostic Assessment
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic accuracy of the 2025 ASAS-SPARTAN classification criteria for axial spondyloarthritis
Lasso di tempo: 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.
At baseline (single assessment during index visit)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Concordance between 2025 ASAS-SPARTAN and 2009 ASAS classification criteria
Lasso di tempo: At baseline (single assessment during index visit)
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.
At baseline (single assessment during index visit)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chinese PLA General Hospital

Collaboratori

Beijing Electric Power Hospital
The General Hospital of Central Theater Command

Investigatori

  • Investigatore principale: Jian Zhu, Chinese PLA General Hospital, Department of Rheumatology and Immunology

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 aprile 2026

Completamento primario (Stimato)

10 aprile 2027

Completamento dello studio (Stimato)

10 aprile 2027

Date di iscrizione allo studio

Primo inviato

21 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2026

Primo Inserito (Effettivo)

24 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ChinaPLAGH-axSpA

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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