Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
研究概览
简要总结
This is an observational study to evaluate the effectiveness and safety of secukinumab in participants with AS who have never used TNFi, JAKi, or IL-17i drugs before.
详细描述
This study is an observational study to evaluate the effectiveness and safety of secukinumab in patients with ankylosing spondylitis who are naive to TNFi/JAKi/IL-17i in Korea. Subjects will be recruited from 10 institutions in Korea. The enrollment period is 8 months from the initiation at the first institution and the follow-up periods are 28 weeks(±4 weeks). Data will be gathered at initial visit, 16 weeks(±4 weeks), and 28 weeks(±4 weeks).
Secukinumab is prescribed within the scope of labeling approved in Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria
- •Subjects who have symptoms of active disease at screening and baseline, as evidenced by BASDAI score of ≥ 4
- •Subjects who have never used TNFi, JAKi, or IL-17i drugs before
- •Patients suitable for secukinumab treatment within the scope of labeling by the Ministry of Food and Drug Safety
- •Subjects who have a time of less than 5 years since AS diagnosis
- •Subjects who are above the age of 18 years and below 40years old
- •Subjects who give informed consent form to participate in the study
排除标准
- •Subjects who are in a medical or psychological condition which may prevent them from participating in the study for the study period(28±4 weeks)
- •Subjects who have congenital/traumatic spinal deformities
- •Subjects currently enrolled in other clinical studies
- •Subjects who have any contraindications to secukinumab treatment
研究组 & 干预措施
group 1
The group will include subjects diagnosed with ankylosing spondylitis (AS) according to the modified 1984 New York criteria, who exhibit symptoms of active disease at both screening and baseline, as indicated by a BASDAI score of ≥ 4. Eligible participants must be biologic-naive, meaning they have no prior use of TNF inhibitors (TNFi), JAK inhibitors (JAKi), or IL-17 inhibitors (IL-17i). Additionally, patients must be deemed suitable for secukinumab treatment as per the labeling guidelines set by the Ministry of Food and Drug Safety. The study will focus on individuals with a time since AS diagnosis of less than 5 years, aged between 18 and 40 years.
干预措施: Secukinumab (Drug)
结局指标
主要结局
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
时间窗: Baseline and 28 weeks
The BASDAI consists of 6 questions to measure the participant's symptoms and disease activity, and each question is evaluated using a numeric rating scale from 0 to 10 or a 10 cm Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem
次要结局
- Change from baseline in C-Reactive Protein (CRP)(Baseline, 16 and 28 weeks)
- Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP(Baseline, 16 and 28 week)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables(Baseline, 16 and 28 weeks)
- Adverse events and Serious Adverse events(From baseline up to 28 weeks)