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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
264
A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare.
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
...and 1 more locations
The proportion of patients experiencing at least one gout recurrence within 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks.
Mean number of gout flares over 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks
Time to resolution of the first gout flare
Time frame: From enrollment to the end of treatment at 24 weeks
Time to first gout recurrence
Time frame: From enrollment to the end of treatment at 24 weeks
Incidence of adverse events and serious adverse events.
Time frame: From enrollment to the end of treatment at 24 weeks
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