Acute gouty arthritis, High risk of recurrent gout.
Conditions
Interventions
Single-arm experimental group:Firsekibart combined with Etoricoxib
Firsekibart 200 mg was given as a single subcutaneous dose on the day of acute exacerbation, plus oral Etoricoxib 120 mg q.d. for 3 d
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Gout Participants must have a confirmed diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria. 2. Participants aged 18 years or older, male or female, who are capable of providing written informed consent, understand the study requirements, and are willing to comply with all study procedures and follow-up assessments throughout the study period. 3. Acute Flare Duration: The current acute gout flare must have occurred within 3 days prior to screening. 4. Pain Severity: Affected joint pain score of >= 50 mm on a 100-mm Visual Analog Scale (VAS) at screening. 5. High Risk of Recurrence Participants must meet at least one of the following high-risk factors for recurrent gout: >= 2 acute gout flares within the previous 12 months; First gout flare accompanied by any of the following risk factors: Aged 480 µmol/L; Presence of metabolic abnormalities, including hypertension, diabetes mellitus, or obesity (BMI >= 28 kg/m²); Presence of chronic kidney disease (eGFR = 10 years; Judged by the investigator to be at high risk of recurrence. 6. Willingness and Ability to Follow Urate-Lowering Therapy (ULT) Management Requirements Participants must be willing to receive and comply with study-specified urate-lowering therapy (ULT) management and meet one of the following conditions: (1) Stable ULT Users Participants receiving ULT for >= 14 days before enrollment may continue the same stable regimen throughout the study for at least 12 weeks. Any treatment modification due to intolerance or inadequate efficacy must be approved by the investigator. (2) ULT-Naïve Participants Participants not receiving ULT before enrollment shall not initiate ULT within the first 14 days after enrollment. After Day 14, initiation of ULT may be considered at the investigator’s discretion based on serum uric acid levels. In principle, allopurinol should not be selected as the initial ULT agent. (3) Non-Stable ULT Users Participants who initiated ULT within 14 days before enrollment (i.e., treatment duration <14 days) shall also follow the rule of no ULT intervention during the first 14 days after enrollment. Initiation or resumption of ULT after Day 14 will be determined by the investigator.
Exclusion criteria
Exclusion criteria: 1. Presence of other inflammatory arthritides (e.g., rheumatoid arthritis, septic arthritis) that may interfere with study assessments. 2. Active infection (e.g., tuberculosis, hepatitis B) or severe immunodeficiency. Participants with evidence of latent tuberculosis infection or risk factors for tuberculosis infection who are unwilling to continue anti-tuberculosis treatment according to local guidelines after study entry. 3. History of hypersensitivity or allergic reactions to the study drugs or related compounds. 4. Contraindications to etoricoxib use, including but not limited to active gastrointestinal ulceration, uncontrolled hypertension, or severe heart failure. 5. Receipt of any of the following medications or treatments: Use of ibuprofen or acetaminophen within 4 hours prior to randomization; Use of diclofenac, tramadol, or local ice/cold pack therapy within 6 hours prior to randomization; Use of celecoxib, naproxen, loxoprofen, codeine-containing analgesics, or colchicine within 12 hours prior to randomization; Use of prednisone >= 10 mg/day or an equivalent corticosteroid dose within 24 hours prior to randomization; Use of meloxicam, etoricoxib, or other short-acting analgesics within 24 hours prior to randomization; Use of long-acting opioid therapy within 14 days prior to screening; Intra-articular corticosteroid injection into the affected joint within 14 days prior to screening; Cumulative systemic corticosteroid treatment for more than 28 days within 12 weeks prior to screening, or continuous treatment with prednisone >= 5 mg/day (or equivalent corticosteroid dose) within 14 days prior to screening; Use of any IL-1 inhibitors, TNF inhibitors, other biologic agents, or investigational medicinal products within 30 days or 3 half-lives (whichever is longer, or as required by local regulations) prior to screening; Continuous systemic immunosuppressive therapy within 3 months prior to screening. 6. Active bleeding disorders involving major organs, significant bleeding tendency, or ongoing anticoagulant therapy. 7. Presence of an infection requiring systemic treatment within 7 days prior to screening. 8. Receiving dialysis treatment, or estimated glomerular filtration rate (eGFR) = 65 years. 10. Presence of significant cardiovascular risk conditions, including but not limited to: Previously diagnosed coronary artery disease with ongoing angina symptoms; Myocardial infarction, acute coronary syndrome, coronary revascularization, ischemic stroke, or transient ischemic attack within 6 months prior to screening; New York Heart Association (NYHA) Class III or IV heart failure; Uncontrolled hypertension (screening systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg, remaining uncontrolled upon repeat measurement); Any other clinically significant cardiovascular disease considered by the investigator to make etoricoxib treatment inappropriate. 11. Pregnant or breastfeeding women. 12. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain response rate at 72 hours;Gout recurrence rate within 12 weeks;Proportion of patients with a >= 50% reduction in VAS pain score at 72 hours.;Incidence and types of adverse events and serious adverse events.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean number of gout flares within 12 weeks.;Trends in inflammatory markers (CRP, SAA, and ESR).; | — |
Countries
China
Contacts
Public ContactZhao Ling
The First Hospital of Jilin University
Outcome results
None listed