The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,250
- 试验地点
- 1
- 主要终点
- BASFI
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older
- •Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria
排除标准
- •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
结局指标
主要结局
BASFI
时间窗: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
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)
Anterior uveitis
时间窗: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
The occurrence of anterior uveitis episodes during the disease course in patients with axSpA
Modified stoke ankylosing spondylitis spinal score (mSASSS)
时间窗: 2-year interval
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.
次要结局
- 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.)
- 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.)
- BASMI(From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.)
研究者
Weiping Kong
Professor
China-Japan Friendship Hospital