Axial Spondyloarthritis (AxSpA)MVAS2025NCT07724847
Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis
An observational study of Axial Spondyloarthritis (AxSpA) and Spondyloarthritis (SpA), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Axial Spondyloarthritis (AxSpA), Spondyloarthritis (SpA), Chronic Back Pain
- What is being tested?
- Diagnostic Assessment
- How many people
- 247 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 10 Apr 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jian Zhu contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jian Zhu, Professor, 13671105096, jian_jzhu@126.com
About this study
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.
Read more
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.
Read the detailed description
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
- Being tested
- Diagnostic Assessment
- Keywords
- Classification Criteria, Validation, Diagnostic Accuracy, ASAS-SPARTAN
- Medical subject headings
- Axial Spondyloarthritis, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic AssessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diagnostic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the 2025 ASAS-SPARTAN classification criteria for axial spondyloarthritis
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.
Measured: At baseline (single assessment during index visit)
Secondary outcomes (1)
Concordance between 2025 ASAS-SPARTAN and 2009 ASAS classification criteria
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.
Measured: At baseline (single assessment during index visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start10 Apr 2026
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial Spondyloarthritis (AxSpA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 247 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Electric Power Hospital, The General Hospital of Central Theater Command
- Responsible party
- Principal investigator, Jian Zhu, Chinese PLA General Hospital
- Investigators
- Jian Zhu, Principal investigator, Chinese PLA General Hospital, Department of Rheumatology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724847
- Sponsor's protocol ID
- ChinaPLAGH-axSpA
- Acronym
- MVAS2025
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ez-Zaitouni Z, Bakker PAC, van Lunteren M, Berg IJ, Landewe R, van Oosterhout M, Lorenzin M, van der Heijde D, van Gaalen FA. Presence of multiple spondyloarthritis (SpA) features is important but not sufficient for a diagnosis of axial spondyloarthritis: data from the SPondyloArthritis Caught Early (SPACE) cohort. Ann Rheum Dis. 2017 Jun;76(6):1086-1092. doi: 10.1136/annrheumdis-2016-210119. Epub 2017 Jan 6.
PubMed 28062405