The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older
Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria
Disqualifiers
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 population
Patients with axial spondyloarthritis
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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)
Time frame
From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.2
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.
Time frame
2-year interval3
Anterior uveitis
The occurrence of anterior uveitis episodes during the disease course in patients with axSpA
Time frame
From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.Secondary outcomes
1
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.
Time frame
From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.2
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.
Time frame
From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.3
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.
Time frame
From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.4
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.
Time frame
From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.Other outcomes
1
CT Syndesmophyte Score
The CT Syndesmophyte Score (CTSS) was developed for the assessment of syndesmophytes on LDCT images.
Time frame
2-year intervalSponsors and contacts
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Source ClinicalTrials.gov