KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ® 5 MG FILM-COATED TABLETS AND XELJANZ® 1 MG/ML ORAL SOLUTION IN PATIENTS WITH ACTIVE PJIA AND JPSA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of patients with treatment emergent treatment-related adverse events
研究概览
简要总结
This study is to assess the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis (JIA) patients in routine clinical practice in Korea. JIA patients experience persistent joint pain, swelling and stiffness. This is a prospective observational study.
Xeljanz is a JAK inhibitor. It was first approved in 2014 for rheumatoid arthritis patients in Korea. The ministry of Food and Drug Safety in Korea mandates for a drug manufacturer to report the post-marketing surveillance after drug's approval or indication extension. This study is to see the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis patients in routine clinical practice in Korea.
This study is seeking patients who:
- Are 2 to less than 18 years of age;
- Are given Xeljanz for the treatment of JIA.
The study sponsor will monitor patients' treatment experience for up to 44 weeks. This will help assess the safety and effects of this study medicine.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Pediatric subjects aged from 2 years to less than 18 years
- •Xeljanz administered according to efficacy/effectiveness on the approved labeling
- •Patients who will administer Xeljanz based on the medical judgement of the investigator
- •Evidence of a personally signed and dated informed consent document indicating that the subject (and a legally acceptable representative) has been informed of all pertinent aspects of the study
排除标准
- •Subjects meeting any of the following criteria will not be included in the study:
- •1) Subjects who are contraindicated from taking Xeljanz according to approved labeling*
- •*Refer to most recently approved label
结局指标
主要结局
Number of patients with treatment emergent treatment-related adverse events
时间窗: Maximum of 12 months from the time of first administration of Xeljanz
Incidence of each adverse event (AE) will be presented with 95% confidence interval. Serious, related, and/or unexpected AEs will be summarized separately. Additionally, in the event that AEs designated as important potential risks and important identified risks are reported, or if a patient in the missing information group is recruited, related safety information will be provided separately.
次要结局
未报告次要终点