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

NCT06844643 | Recruiting

• 1 other identifier: 2023-NHLHCRF-YYPPLC-TJ-02
• Study Type: observational
• Target: 2,250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankylosing Spondylitis (AS); Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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 Outcomes (5)

• ASDAS-CRP

  From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.

• ASDAS-ESR

  From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.

• BASDAI

  From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.

• BASMI

  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.

  From enrollment to 16 weeks，1 year; after 1year on a an average of 6 months until study completion.

Other Outcomes (1)

• CT Syndesmophyte Score

  2-year interval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with axial spondyloarthritis

You may qualify if:

• Patients aged 18 years or older
• Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

weiping kong

CONTACT

0086-10-13611038252; kongweiping75@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 25, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)