The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Axial Spondyloarthritis, Ankylosing Spondylitis (AS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This is an observational cohort study of Chinese patients (≥18 years of age) diagnosed with axSpA. Patients are followed at 4-6 month intervals. Data will be collected at baseline and at every follow-up time points. Primary outcomes are the structural damage measured with imaging(Conventional radiography, low-dose CT and MRI) and the disease activity measured with the Ankylosing Spondylitis Disease Activity Scale (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Secondary outcomes are inflammatory markers, Bath ankylosing spondylitis functional index (BASFI) and Bath ankylosing spondylitis metrology index (BASMI).
Primary outcome measures
- BASFI [Time frame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.]
- Modified stoke ankylosing spondylitis spinal score (mSASSS) [Time frame: 2-year interval]
- Anterior uveitis [Time frame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.]
Secondary outcome measures (5)
- ASDAS-CRP [Time frame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.]
- ASDAS-ESR [Time frame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.]
- BASDAI [Time frame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.]
- BASMI [Time frame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.]
- The Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system. [Time frame: From enrollment to 16 weeks，1 year; after 1year on a an average of 6 months until study completion.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06844643 · 2023-NHLHCRF-YYPPLC-TJ-02