Post-Marketing Surveillance of Humira Injection in Korean JIA 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
- 28
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, underlying diseases and complications especially in regard to purified protein derivative (PPD) skin test, and chest X-ray. At routine visits for Humira Injection administration, which will occur according to usual medical practice, concomitant medication information and adverse events information will be collected for up to 70 days after the last administration of Humira.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 2 years of age who were diagnosed with polyarticular juvenile idiopathic arthritis (JIA) or patients from 6 years of age who were diagnosed with enthesitis-related arthritis (ERA).
- •Polyarticular juvenile idiopathic arthritis (JIA) patients for whom the response to previous disease-modifying anti rheumatic drug therapy has been inadequate
- •Patients who give written authorization form to use their personal and health data from legal parents or representative.
- •Physician will refer to the product market authorization (label) for inclusion criteria.
排除标准
- •Patients with known hypersensitivity to Humira or any of its excipients.
- •Patients who is participating on other clinical trials.
- •Physician will refer to the product market authorization (label) for exclusion criteria.
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
次要结局
- Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment(From the first administration (Day 1) to approximately 12 weeks (±4 weeks))
- Physician's Global Assessment of the Disease(From the first administration (Day 1) to approximately 12 weeks (±4 weeks))
- Parent's Global Assessment for Effectiveness(From the first administration (Day 1) to approximately 12 weeks (±4 weeks))