An observational study in Axial Spondyloarthritis (AxSpA), Spondyloarthritis (SpA) and Chronic Back Pain, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Chinese PLA General Hospital · Observational
Among 16 studies in Axial Spondyloarthritis with a site in China — 6 open to participants now, 7 under way, none of them phase 3. Axial Spondyloarthritis · China.
Among the 16 studies in Axial Spondyloarthritis with a site in China, this one is one of 2 that started in 2026, is one of 3 observational ones, and was the 16th registered.
186 studies on the registry are indexed under Axial Spondyloarthritis; 56 are open to participants now.
Browse Axial Spondyloarthritis studies →6 of the 16 studies in Axial Spondyloarthritis with a site in China are open now. Recruiting first, the newest first:
China-Japan Friendship Hospital · Sites in China
Ages 18+
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Sites in China
Ages 18+
The First Affiliated Hospital of Xiamen University · Sites in China
Ages 18–65
The First Affiliated Hospital of Xiamen University · Sites in China
Ages 18+
Chinese PLA General Hospital · Sites in China
Ages 18–65
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 38 Axial Spondyloarthritis studies recruiting now, 20 (53%) set no upper age limit and 12 (32%) stop at 75 or younger; 5 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 247 is above the median of 180 across 61 observational studies indexed under Axial Spondyloarthritis.
Median enrollment 274 across the 13 interventional studies, 247 across the 3 observational. Of the 9 that completed or were terminated, 4 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 16 have an industry lead sponsor. The 10 most frequent:
Chinese PLA General Hospital is the lead sponsor of 571 studies on the registry; 207 are open to participants now.
Chinese PLA General Hospital has 2 studies filed under Axial Spondyloarthritis — fewer than ten, so there is no comparison to draw.
2 of the studies in Axial Spondyloarthritis with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07133633Merck Sharp & Dohme LLCA Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013) | 2027-03-29 |
| NCT07724847Chinese PLA General HospitalMulticenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis | 2027-04-10 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Axial Spondyloarthritis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
Study Population:
Assessments:
Diagnostic Evaluation:
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:
Data Management:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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
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.
Time frame: At baseline (single assessment during index visit)
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.
Time frame: At baseline (single assessment during index visit)
Plan to share: 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.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.
Of 28 observational studies under Axial Spondyloarthritis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 48. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese PLA General Hospital →