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24-Week Recurrence Rate of Gout Following Firsekibart Treatment
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
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).
Official title: The 24-Week Recurrence Rate of Acute Gouty Arthritis in Patients Treated With Firsekibart: A Multicenter, Prospective, Real-World Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2026-05-07
Completion Date
2029-08-28
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
Firsekibart
A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare.
Locations (11)
Fuzhou University Affiliated Provincial Hospital
Fuzhou, China
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Tongde Hospital of Zhejiang Province
Hangzhou, China
Zhejiang Hospital
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Changxin People's Hospital
Huzhou, China
Jinhua Municipal Central Hospital
Jinhua, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
The First People's Hospital of Wenlin
Wenzhou, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China