A Real-world, Prospective, Multicenter Study to Assess the Safety and Effectiveness of Secukinumab (Cosentyx®) in Patients Aged 6 to Less Than 18 Years With Moderate to Severe Chronic Plaque Psoriasis in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- AEs/SAEs/AESIs type and frequency
研究概览
简要总结
This was a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx® for up to 52 weeks.
详细描述
Patients who were about to initiate Cosentyx® or had started Cosentyx® within the last 4 weeks and met the eligibility criteria were enrolled. Patients were followed via routine visits in real clinical practice up to 52 weeks. Data from medical records, including safety and effectiveness information of Cosentyx® (e.g., AE, SAE, physical examinations, laboratory tests, disease assessments, etc.) were collected at each visit. No additional study visits, examinations, laboratory tests or procedures were mandated throughout the study.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting all of the following criteria are eligible for inclusion in this study:
- •Written assent and informed consent must be obtained as per local regulations prior to any study procedures.
- •Diagnosed with moderate to severe plaque psoriasis.
- •Initiating treatment with Cosentyx® or having started Cosentyx® treatment within the last 4 weeks in routine clinical practice, and its prescription is independent of this study.
- •Aged 6 to less than 18 years at the time they are prescribed Cosentyx®.
- •Have valid PASI and IGA mod 2011 score at the time they are prescribed Cosentyx®.
排除标准
- •Patients meeting any of the following criteria are not eligible for inclusion in this study:
- •Patients previously treated with other biologics.
- •Patients participating in other clinical trials or who previously participated in clinical trials within 30 days before Cosentyx® initiation or a period of 5 half-lives of the investigational drug, whichever is longer.
- •Patients in conditions which in the judgment of the clinical investigator renders the patient unsuitable for the study.
结局指标
主要结局
AEs/SAEs/AESIs type and frequency
时间窗: 52 weeks
Adverse events (AEs)/ Serious adverse events (SAEs)/Adverse events of special interest (AESIs).
次要结局
- Percentage of patients who achieved PASI 75 response(Week 12)
- Percentage of patients who achieved IGA mod 2011 0 or 1 response(Week 12)
- Percentage of patients who achieved PASI 90/100 response(Week 12)
- Absolute value change from baseline of PASI score over time(Up to week 52)
- Percentage of patients who achieved PASI 75/90/100 response/IGA mod 2011 0 or 1 response over time(Up to week 52)
- Absolute value change from baseline of IGA mod 2011 score over time(Up to week 52)