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临床试验/NCT03557060
NCT03557060已完成不适用

NUCALA ® Subcutaneous Injection Special Drug Use Investigation (EGPA, Long-term)

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 4,115 人开始时间: 2018年6月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
4,115
试验地点
1
主要终点
Number of Participants With Adverse Drug Reactions (ADRs)

研究概览

简要总结

This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA). All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. Approximately 300 subjects will be included in the study. The observation period per subject is up to 96 weeks (2 years) from the start of NUCALA administration for EGPA at a maximum. If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. The total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of EGPA indication to the lifting of approval condition. NUCALA is a registered trademark of the GlaxoSmithKline [GSK] group of companies.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included.
  • Subjects who had been registered to NCT03028480 for bronchial asthma, but had a change in treatment purpose from bronchial asthma to EGPA during the observation period

排除标准

  • Not applicable.

研究组 & 干预措施

Participants with EGPA

Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study

干预措施: Nucala (Drug)

结局指标

主要结局

Number of Participants With Adverse Drug Reactions (ADRs)

时间窗: Up to 96 Weeks

ADR is defined as adverse events for which a causal relationship with the drug was not ruled out.

Response Rate Based on Global Assessment of Effectiveness

时间窗: Up to 96 Weeks

Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment\*100. Percentage values are rounded-off.

Time to EGPA Relapse

时间窗: Up to 96 Weeks

EGPA relapse was defined as conditions meeting any of the following 3 criteria in participants presenting with worsening of EGPA (newly developed symptoms or worsening of existing symptoms), and the presence or absence of relapse and the time to the first relapse were evaluated: 1. corticosteroid administration newly started or a corticosteroid dose increased; 2. immunosuppressant administration newly started or an immunosuppressant dose increased; 3. hospitalization for the treatment of EGPA. Participants were considered responder for EGPA relapse if they met with any one of the three criteria mentioned above.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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