Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart.
Primary Endpoint The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Secondary Endpoints The mean number of gout recurrences within 24 weeks after randomization;The duration of the first gout recurrence;The proportion of patients experiencing at least one gout recurrence within 12 weeks after randomization;Time to first gout recurrence after randomization;Patient treatment satisfaction at 24 weeks after randomization, assessed using a Likert scale.
Study Design and Methods Patients with acute gouty arthritis who had received Firsekibart as initial treatment and experienced no recurrence during the first 24 weeks of treatment were eligible for enrollment and randomization in this study. Eligible patients were randomized to either a scheduled dosing group or an as-needed dosing group.
In the scheduled dosing group, patients received study treatment immediately after enrollment. In the as-needed dosing group, patients entered an observation period after enrollment and received study treatment only in the event of recurrence.
During the study, gout recurrence was recorded using patient diary cards. Telephone follow-up was conducted every 4 weeks to confirm recurrence status. On-site visits were performed at Weeks 12 and 24, as well as at the time of gout recurrence, for collection of efficacy-related assessments. Adverse events (AEs) and serious adverse events (SAEs) were followed until 12 weeks after the last dose of study drug.
Treatment Arms Scheduled Dosing Group (Intervention Group): Firsekibart 200 mg was administered by subcutaneous injection on the day of randomization.
As-Needed Dosing Group (Control Group): Patients were observed after randomization. If recurrence occurred, patients were required to return to the hospital within 4 days and receive Firsekibart 200 mg by subcutaneous injection.
Age 18 to 75 years (inclusive), male or female;**
Meet the 2015 ACR/EULAR Gout Classification Criteria;**
Received initial treatment with Firsekibart 200 mg via subcutaneous injection for 24 weeks, and experienced no gout flares during this 24-week period;**
Had≥2 gout flares within 1 year prior to the first administration of Firsekibart；
History of hypersensitivity to the study drug or similar classes of drugs;
Systemic treatment with corticosteroids, or use of colchicine/NSAIDs within 24 weeks prior to enrollment;
Confirmed active visceral bleeding, or severe bleeding tendency, or currently receiving anticoagulation therapy with heparin;
Confirmed secondary gout;
Parallel
Scheduled Firsekibart administration
DrugA 200 mg subcutaneous injection of Firsekibart will be administered on the day of randomization or the day of gout flare.
As-Needed Firsekibart Administration
DrugFollowing randomization, patients will remain under continuous observation. In the event of recurrence, patients should return to the hospital within 4 days to receive a 200 mg subcutaneous injection of Firsekibart.
The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Mean number of gout flares over 24 weeks after randomization.
Time to resolution of the first gout flare
Time to first gout flare
Proportion of patients with at least one gout flare
Change from baseline in CRP and hsCRP
Change from baseline in IL-6、IL-1β and TNF-α
Change from baseline in ESR
Percentage change from baseline in tophus diameter
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