Post-Marketing Surveillance of Humira in Korean Pediatric CD Patients Under the "New-Drug Re-examination"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 主要终点
- Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs
研究概览
简要总结
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling)
- •Patients who have given written authorization to use their personal health data for the purposes of this study.
排除标准
- •Any contraindications to Humira as listed on the approved product market authorization (labeling)
- •Patients who is participating on other clinical trials.
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs
时间窗: From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).
An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded.
次要结局
未报告次要终点