Ireland
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Recruiting Observational

The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study

NCT06844643 · tracked via the Priya Life Science Japan tracker
Phase
Observational
Started
2025-03-01
Last updated
2026-04-13

Condition(s) studied

Axial SpondyloarthritisAnkylosing Spondylitis (AS)

Study summary

An observational, ambispective cohort to learn about the disease progression of axial spondyloarthritis (axSpA) according to the changes from baseline in measures of disease activity, function, and imaging.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18 years or older * Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria Exclusion Criteria: * Presence of severe, unstable medical conditions that may interfere with the study assessments, including but not limited to: End-stage renal disease (eGFR \< 30 mL/min/1.73m²) Severe cardiovascular disease Active malignancy or malignancy requiring ongoing treatment * Current diagnosis of schizophrenia, other psychotic disorders, severe cognitive impairment, or epilepsy with recurrent uncontrolled seizures, which, in the opinion of the investigator, may impair the ability to provide informed consent or comply with follow-up visits. * Pregnant or lactating women

Primary outcome measure(s)

  • BASFI — From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
    The Bath Ankylosing Spondylitis Functional Index (BASFI) is a self-administered instrument comprising 10 items. The first 8 items assess functional activities (e.g., bending, reaching, climbing), while items 9 and 10 assess the patient's ability to cope with daily life and the impact of morning stiffness, respectively. Each item is scored on a 10 cm visual analog scale (or numerical rating scale), and the final score is the mean of the 10 items, ranging from 0 (best function) to 10 (worst function)
  • Modified stoke ankylosing spondylitis spinal score (mSASSS) — 2-year interval
    The mSASSS is a valid and widely used method for assessing radiographic progression in AS, correlating with worsening measures of disease signs and symptoms, spinal mobility and physical function.
  • Anterior uveitis — From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
    The occurrence of anterior uveitis episodes during the disease course in patients with axSpA

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06844643 on ClinicalTrials.gov ↗ ← All trials in Japan