24-Week Recurrence Rate of Gout Following Firsekibart Treatment
The 24-Week Recurrence Rate of Acute Gouty Arthritis in Patients Treated With Firsekibart: A Multicenter, Prospective, Real-World Study
Study Objective: To evaluate the 24-week recurrence rate and safety of Firsekibart in patients with acute gouty arthritis in a real-world clinical setting.
Study Methods: This study utilizes a multicenter, prospective, observational, real-world study design. The study plans to enroll all cases that receive Firsekibart for the first time and meet the inclusion and exclusion criteria between March 1, 2026, and February 28, 2029, with a follow-up period of 24 weeks. This study will not intervene in clinical treatment regimens; it will solely record and analyze the diagnosis and treatment data that actually occur.
Study Outcomes: Primary Outcome: The proportion of patients with at least one gout recurrence (flare) at 24 weeks.Secondary Outcomes: 1. Average number of gout recurrences over 24 weeks; 2. Time to the first gout recurrence; 3. Duration of the first gout recurrence; 4. Incidence of adverse events (AEs) and serious adverse events (SAEs).
研究概览
研究类型
介入性
注册 (估计的)
264
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：华香 吴
- 电话号码：0086-13757118395
- 邮箱：wuhx8855@zju.edu.cn
学习地点
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Fuzhou、中国
- Fuzhou University Affiliated Provincial Hospital
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接触：
- Fei Gao
- 电话号码：0086-13665013469
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Hangzhou、中国
- Zhejiang Provincial People's Hospital
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接触：
- Lijuan Wang
- 电话号码：0086-13567134447
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Hangzhou、中国
- The Second Affiliated Hospital Zhejiang University School of Medicine
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接触：
- 华香 吴
- 邮箱：wuhx8855@zju.edu.cn
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Hangzhou、中国
- Zhejiang Hospital
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接触：
- Fang Yuan
- 电话号码：0086-18072963566
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Hangzhou、中国
- The Second Affiliated Hospital of Zhejiang Chinese Medical University
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接触：
- Kepeng Yang
- 电话号码：0086-17826873536
- 邮箱：ykp1029@126.com
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Hangzhou、中国
- Tongde Hospital of Zhejiang Province
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接触：
- Qin Chen
- 电话号码：0086-15869192858
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Huzhou、中国
- Changxin People's Hospital
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接触：
- Yingying Wang
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Jinhua、中国
- Jinhua Municipal Central Hospital
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接触：
- Li Hua
- 电话号码：0086-13758992315
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Ningbo、中国
- Ningbo Medical Center Lihuili Hospital
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接触：
- Li Zhou
- 电话号码：0086-13858287828
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Wenzhou、中国
- The Second Affiliated Hospital of Wenzhou Medical University
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接触：
- Hong Wang
- 电话号码：0086-13957756514
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Wenzhou、中国
- The First People's Hospital of Wenlin
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接触：
- Yongjun Cheng
- 电话号码：0086-13958633696
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 18 to 75 years (inclusive), male or female;
- Meet the 2015 ACR/EULAR Gout Classification Criteria;
- Two or more acute gout flares within a year;
- In the acute phase of a gout flare;
- Voluntarily signed the Informed Consent Form (ICF).
Exclusion Criteria:
- History of hypersensitivity to the study drug or similar classes of drugs;
- Pregnant or breastfeeding women;
- History of clinically significant diseases, including: Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) < 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs;History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG ;
- Confirmed active tuberculosis infection;
- History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
- Presence of infection requiring systemic treatment within 7 days prior to screening;
- Laboratory abnormalities at screening as follows: White blood cellcount or absolute neutrophil count below the lower limit of normal at the study site; Platelet count ≤100×10^9/L; Total bilirubin > 1.5 times ULN (Upper Limit of Normal); AST/ALT > 3 times ULN; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m²; Triglycerides > 5.7 mmol/L;
- Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：实验组
|
A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The proportion of patients experiencing at least one gout recurrence within 24 weeks.
大体时间：From enrollment to the end of treatment at 24 weeks.
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From enrollment to the end of treatment at 24 weeks.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Mean number of gout flares over 24 weeks.
大体时间：From enrollment to the end of treatment at 24 weeks
|
From enrollment to the end of treatment at 24 weeks
|
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Time to resolution of the first gout flare
大体时间：From enrollment to the end of treatment at 24 weeks
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From enrollment to the end of treatment at 24 weeks
|
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Time to first gout recurrence
大体时间：From enrollment to the end of treatment at 24 weeks
|
From enrollment to the end of treatment at 24 weeks
|
|
Incidence of adverse events and serious adverse events.
大体时间：From enrollment to the end of treatment at 24 weeks
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From enrollment to the end of treatment at 24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月7日
初级完成 (估计的)
2029年8月28日
研究完成 (估计的)
2029年8月28日
研究注册日期
首次提交
2026年5月24日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年6月2日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 2026-0160
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.