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

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.

Study Overview

• Status: Recruiting
• Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis (AS)

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).

• Study Type: Observational
• Enrollment (Estimated): 2250

Contacts and Locations

• Study Contact: Name: weiping kong; Phone Number: 0086-10-13611038252; Email: kongweiping75@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: wei Kong, Docotr; Phone Number: 0086-10-13611038252; Email: kongweiping75@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with axial spondyloarthritis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified stoke ankylosing spondylitis spinal score (mSASSS)	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.	2-year interval
BASFI	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)	From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
Anterior uveitis	The occurrence of anterior uveitis episodes during the disease course in patients with axSpA	From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system.	The Spondyloarthritis Research Consortium of Canada (SPARCC) developers have created the SPARCC MRI scoring methods to assess inflammatory activity in patients with SpA.	From enrollment to 16 weeks，1 year; after 1year on a an average of 6 months until study completion.
ASDAS-CRP	ASDAS-CRP=0.12 x back pain+0.06 x duration of morning stifness +0.11 x patient global+0.07 x peripheral pain/swelling +0.58xIn(CRP+1) The result of the calculation is the ASDAS-CRP score, which is used to classify the disease activity level. Generally, a score of <1.3 indicates inactive disease, 1.3 - 2.1 indicates low disease activity, 2.1 - 3.5 indicates moderate disease activity, and >3.5 indicates high disease activity.	From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
ASDAS-ESR	ASDAS-ESR=0.08 x back pain +0.07 x duration of morning stiffness + 0.11 x patient global + 0.09 x peripheral pain/swelling +0.29x√(ESR) The calculated score is used to determine the disease activity level. Typically, a score of <1.3 suggests inactive disease, 1.3 - 2.1 indicates low disease activity, 2.1 - 3.5 represents moderate disease activity, and >3.5 means high disease activity.	From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
BASDAI	BASDAI is a validated self assessment tool used to determine disease activity i. Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.	From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
BASMI	The Bath Ankylosing Spondylitis Metrology Index (BASMI) is a composite index derived from five clinical measurements of spinal and hip mobility: cervical rotation, tragus-to-wall distance, lumbar side flexion, lumbar flexion (modified Schober), and intermalleolar distance . Each component is scored on a scale from 0 to 10, and the total score (0-10, with 10 indicating the most severe impairment) is the mean of these five scores.	From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT Syndesmophyte Score	The CT Syndesmophyte Score (CTSS) was developed for the assessment of syndesmophytes on LDCT images.	2-year interval

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Axial Spondyloarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: 2023-NHLHCRF-YYPPLC-TJ-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No