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NOT YET RECRUITING
NCT07625514
NA

24-Week Recurrence Rate of Gout Following Firsekibart Treatment

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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

DRUG

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