NCT07737730尚未招募不适用
A Prospective, Observational, Multicentre Study to Assess the Safety of Subcutaneous Secukinumab 150 mg Solution for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA) Over a Period of 16 Weeks
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The aim of this study is to assess the safety of secukinumab in Indian adult participants with axSpA, AS, and nr-axSpA over a 16-week treatment period. The present study is being undertaken to fulfill the Post Marketing Surveillance (PMS) mandate by the Health Authority (HA) to evaluate the safety of secukinumab solution for injection administered subcutaneously in a pre-filled pen in the indicated population under real-world clinical practice conditions.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant or his/her legally acceptable representative (LAR) who are willing to voluntarily provide signed informed consent for participation in the study.
- •Adult male or female participants (≥18 years) diagnosed with axSpA, AS, and nr-axSpA.
排除标准
- •Participants who meet any contraindication outlined in the current Prescribing Information (PI)/Package Insert for secukinumab at the time of screening.
- •Pregnant or lactating women.
- •Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
结局指标
主要结局
Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Baseline through Week 20
次要结局
- Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, Weeks 4, 8, 12, and 16)
研究者
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