A Post Marketing Surveillance of Jakavi® (Ruxolitinib) in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 14
- 主要终点
- Proportion of patients with a SAE/ SADR
研究概览
简要总结
This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Jakavi® (ruxolitinib) in the real-world clinical setting in Korean Graft-versus-Host disease (GvHD) patients
详细描述
The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Jakavi®. All participants who receive at least one dose of the drug and are in the follow-up assessment or early discontinuation (withdrawal) will be the safety population. This study will enroll patients who are newly starting Jakavi® and patients who have been taking Jakavi® prior to study participation. Considering the current clinical practice, a 24 weeks follow-up period of ruxolitinib treatment is needed to assess the safety and the durable effectiveness of the treatment. Mandatory additional safety monitoring will be conducted following the last dose of the treatment for further AE assessments.
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
- 12 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who diagnosed with GvHD and currently receiving or going to receive Jakavi® treatment according to locally approved label
- •Patients who are willing to provide written informed consent prior to study enrollment
排除标准
- •Patients under 12 years old
- •Patients with contraindication according to locally approved label of Jakavi®
- •Patients who receive or are going to receive any investigational medicine during the observation period.
研究组 & 干预措施
ruxolitinib
Patients currently receiving or going to receive Jakavi® treatment according to locally approved label
干预措施: ruxolitinib (Other)
结局指标
主要结局
Proportion of patients with a SAE/ SADR
时间窗: Up to 24 weeks
Proportion of patients with a serious AE (SAE)/ serious ADR (SADR) will be provided
Proportion of patients with an AE/ ADR
时间窗: Up to 24 weeks
Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided
Proportion of patients with an UAE/ UADR
时间窗: Up to 24 weeks
Proportion of patients with an unexpected AE (UAE)/ unexpected ADR (UADR) will be provided
Proportion of patients with a SUAE/ SUADR
时间窗: Up to 24 weeks
Proportion of patients with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) will be provided
次要结局
- Death rate(Week 4 and Week 24)
- Treatment failure rate(Week 4 and Week 24)
- Percentage change in CBC(Baseline and Week 24)
- Overall response rate (ORR)(Week 4 and Week 24)