A Single Arm, Multi-center Study to Assess the Long-term Real-world Safety and Effectiveness of Nucala in EGPA Patients Who Have Already Used Nucala for at Least 96 Weeks in Japan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI)
研究概览
简要总结
Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as the Churg-Strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels. NUCALA® (mepolizumab 300 milligrams [mg], subcutaneous administration) was approved in Japan in 2018 for the treatment of EGPA in adult participants. This is a single-arm, multi-center, prospective, non-interventional study that aims to assess long-term (2 to 4 years) real-world safety and effectiveness of NUCALA. Approximately 120 participants who completed the NUCALA Post Marketing Surveillance (PMS) study (National Clinical Trial [NCT]03557060) will be enrolled in the study.
NUCALA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants with EGPA of >=20 years of age inclusive, at the time of signing the informed consent.
- •Participants must have a current clinical diagnosis of EGPA by physician.
- •Participants have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan.
- •Participants thus were registered and completed the NUCALA PMS study (special drug use investigation; Protocol Number 208505, NCT03557060) prior to be enrolled in this study.
- •Physician's decision to continue treatment with NUCALA for the treatment of EGPA as mentioned in the current label in Japan.
- •Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.
排除标准
- •Participants who have previously discontinued NUCALA treatment for EGPA for more than 12 weeks.
- •Participating in another clinical trial within the past 12 months, in which the participant has been exposed to an investigational or non-investigational pharmaceutical product.
- •Participants with any reasons that in physician's opinion would place the participants at risk.
- •Participants who are pregnant or breastfeeding.
结局指标
主要结局
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI)
时间窗: Up to 96 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with study participation, whether or not considered related to study participation. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment. An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included Hypersensitivity (including anaphylaxis), Infections and Malignant tumors.
Number of Participants With Adverse Drug Reactions (ADRs)
时间窗: Up to 96 weeks
An ADR is defined as an AE for which the investigator classifies the possible relationship to study intervention as "Yes". ADRs related to NUCALA were collected.
次要结局
- Percentage of Participants With Clinical Symptoms(At 96 weeks)
- Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse(Up to 96 weeks)
- Annualized Rate of Hospitalization for EGPA-related Events(Up to 96 weeks)
- Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events(Up to 96 weeks)
- Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS)(Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96)
- Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent)(Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96)