Evaluation of the Optimal Concentration Range of Adalimumab for Ankylosing Spondylitis in a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in ASDAS
研究概览
简要总结
The optimal plasma concentration range of adalimumab in Chinese patients with active ankylosing spondylitis remains unknown, the aims of this study is to determine the concentration-effect relationship, and explore the effect of anti-drug antibody or biomarkers on clinical outcomes in a real-world setting.
详细描述
This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment. The primary outcome is the mean change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Consent of the patient.
- •Patient who meets the definition of Ankylosing Spondylitis based on the 1984 Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis (BASDAI ≥ 4, Back pain ≥ 4).
- •Patients who have indication of adalimumab.
- •Patients on NSAIDs treatment need to be on a stable dose for at least 4 weeks.
排除标准
- •(1) Hepatitis B or tuberculosis patients
研究组 & 干预措施
adalimumab TDM
Patients with active ankylosing spondylitis receiving adalimumab treatment.
干预措施: The study is observational (Other)
结局指标
主要结局
Mean Change From Baseline in ASDAS
时间窗: Week 24
ASDAS will be measured at week 24 and will be compared to baseline
次要结局
- Safety analysis - Occurence of adverse event(Week 24)
- ASAS20 response(Week 2, 4, 8, 12, 24)
- ASAS40 response(Week 2, 4, 8, 12, 24)
- BASDAI50 response(Week 2, 4, 8, 12, 24)
- ASDAS response(Week 2, 4, 8, 12, 24)
- ASDAS remission(Week 2, 4, 8, 12, 24)
研究者
Miao Liyan
vice president
The First Affiliated Hospital of Soochow University