The 24-Week Recurrence Rate of Acute Gouty Arthritis in Patients Treated With Firsekibart: A Multicenter, Prospective, Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 试验地点
- 11
- 主要终点
- The proportion of patients experiencing at least one gout recurrence within 24 weeks.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Experimental group
干预措施: Firsekibart (Drug)
结局指标
主要结局
The proportion of patients experiencing at least one gout recurrence within 24 weeks.
时间窗: From enrollment to the end of treatment at 24 weeks.
次要结局
- Time to resolution of the first gout flare(From enrollment to the end of treatment at 24 weeks)
- Time to first gout recurrence(From enrollment to the end of treatment at 24 weeks)
- Mean number of gout flares over 24 weeks.(From enrollment to the end of treatment at 24 weeks)
- Incidence of adverse events and serious adverse events.(From enrollment to the end of treatment at 24 weeks)