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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firsekibart | Drug | A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients experiencing at least one gout recurrence within 24 weeks. | From enrollment to the end of treatment at 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of gout flares over 24 weeks. | From enrollment to the end of treatment at 24 weeks | |
| Time to resolution of the first gout flare | From enrollment to the end of treatment at 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 华香 吴 | Contact | 0086-13757118395 | wuhx8855@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou University Affiliated Provincial Hospital | Fuzhou | China |
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| Time to first gout recurrence |
| 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 |
| The Second Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | China |
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| Tongde Hospital of Zhejiang Province | Hangzhou | China |
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| Zhejiang Hospital | Hangzhou | China |
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| Zhejiang Provincial People's Hospital | Hangzhou | China |
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| Changxin People's Hospital | Huzhou | China |
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| Jinhua Municipal Central Hospital | Jinhua | China |
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| Ningbo Medical Center Lihuili Hospital | Ningbo | China |
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| The First People's Hospital of Wenlin | Wenzhou | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | China |
|