Axial SpondyloarthritisDPCASPANCT06844643
The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study
An observational study of Axial Spondyloarthritis and Ankylosing Spondylitis (AS), run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis (AS)
- How many people
- 2,250 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with axial spondyloarthritis
Who may be able to join
- Patients aged 18 years or older
- Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
wei Kong, Docotr, 0086-10-13611038252, kongweiping75@126.com
About this study
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.
Read the 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).
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 2-year interval
Anterior uveitis
The occurrence of anterior uveitis episodes during the disease course in patients with axSpA
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
The Spondyloarthritis Research Consortium of Canada (SPARCC) developers have created the SPARCC MRI scoring methods to assess inflammatory activity in patients with SpA.
Measured: From enrollment to 16 weeks，1 year; after 1year on a an average of 6 months until study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiping Kong, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844643
- Sponsor's protocol ID
- 2023-NHLHCRF-YYPPLC-TJ-02
- Acronym
- DPCASPA
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No