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.
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
2,250
China-Japan Friendship Hospital
Beijing, China
RECRUITINGBASFI
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.
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 interval
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.
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.
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.
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Time frame: 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.
Time frame: 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.
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.
The Spondyloarthritis Research Consortium of Canada (SPARCC) developers have created the SPARCC MRI scoring methods to assess inflammatory activity in patients with SpA.
Time frame: From enrollment to 16 weeks，1 year; after 1year on a an average of 6 months until study completion.