24-Week Recurrence Rate of Gout Following Firsekibart Treatment
Key facts
- Where
- Fuzhou, Hangzhou, Huzhou, Jinhua, Ningbo, and Wenzhou, ChinaSee the 11 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07625514, who can take part
Where in China
- Fuzhou University Affiliated Provincial HospitalFuzhou, ChinaContact: Fei GaoNo longer taking part
- The Second Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhou, ChinaContact: Kepeng YangNo longer taking part
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: 华香 吴No longer taking part
- Tongde Hospital of Zhejiang ProvinceHangzhou, ChinaContact: Qin ChenNo longer taking part
- Zhejiang HospitalHangzhou, ChinaContact: Fang YuanNo longer taking part
- Zhejiang Provincial People's HospitalHangzhou, ChinaContact: Lijuan WangNo longer taking part
- Changxin People's HospitalHuzhou, ChinaContact: Yingying WangNo longer taking part
- Jinhua Municipal Central HospitalJinhua, ChinaContact: Li HuaNo longer taking part
- Ningbo Medical Center Lihuili HospitalNingbo, ChinaContact: Li ZhouNo longer taking part
- The First People's Hospital of WenlinWenzhou, ChinaContact: Yongjun ChengNo longer taking part
- The Second Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: Hong WangNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07625514
- Record updated
- 4 June 2026
- Original description
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.Read full original descriptionShow less
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).
Inclusion: 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: Presence of infection requiring systemic treatment within 7 days prior to screening; History of hypersensitivity to the study drug or similar classes of drugs; Confirmed active tuberculosis infection; History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases; Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study; 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 ; 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; Pregnant or breastfeeding women.