acute gouty arthritis
Conditions
Interventions
Experimental group:An IL-1 inhibitor combined with compound betamethasone
Sponsors
Henan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able to voluntarily sign the informed consent form and voluntarily cooperate to complete the trial according to the protocol; 2. Age >= 18 years; 3. Diagnosed with gout according to the 2015 American College of Rheumatology (ACR) classification criteria for gout; 4. Current acute gout attack occurred within 4 days before the screening period; 5. Target joint pain score during the screening period VAS >= 50 mm (VAS 0-100 mm); 6. Patients have clinically assessed high risk of recurrence and meet at least one of the following criteria: (1) Experienced = 2 acute attacks in the past 12 months; (2) First gout attack accompanied by any of the following risk factors: age 480 µmol/L, combined with hypertension, diabetes, obesity (BMI >= 28) or other metabolic abnormalities, combined with chronic kidney disease [glomerular filtration rate (eGFR) = 14 days must maintain a stable dosing regimen for at least 12 weeks during the trial. Unless assessed by the investigator that the current urate-lowering regimen causes intolerance, poor efficacy, or overly low uric acid levels, adjustments to the regimen including changing the drug, dosage reduction, or discontinuation are allowed; (2) Patients not using ULT before randomization are not allowed to use urate-lowering treatment within 14 days after randomization. After 14 days, the investigator decides based on uric acid levels whether to start urate-lowering treatment. In principle, allopurinol is not selected for urate-lowering treatment; (3) Patients using ULT before randomization but not stable for 14 days are not allowed to use urate-lowering treatment within 14 days after randomization. After 14 days, the investigator decides based on uric acid levels whether to start urate-lowering treatment. In principle, patients who have not previously used allopurinol cannot use allopurinol for urate-lowering treatment in this study.
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions to the study drug or similar hormonal drugs; 2. Prior intolerance or poor response to steroid medications for gout attacks; 3. Received any of the following drugs or treatments: (1) Use of ibuprofen or acetaminophen within 4 hours prior to randomization; (2) Use of diclofenac, tramadol, or application of topical ice packs/cold packs within 6 hours prior to randomization; (3) Use of celecoxib, naproxen, loxoprofen, lofenac, or colchicine within 12 hours prior to randomization; (4) Use of >=10 mg prednisone or an equivalent dose of steroids within 24 hours prior to randomization; (5) Use of meloxicam, etoricoxib, or other short-acting analgesics within 24 hours prior to randomization; (6) Use of long-acting opioid medications within 14 days prior to screening; (7) Intra-articular glucocorticoid injection in the affected joint within 14 days prior to screening; (8) Cumulative use of >28 days within 12 weeks prior to screening, or continuous use of >=5 mg/day prednisone (or equivalent corticosteroids) within 14 days prior to screening; (9) Use of any IL-1 blockers, TNF inhibitors, other biologics, or investigational drugs within 30 days or 3 half-lives prior to screening (whichever is longer, or as required by local regulations); (10) Continuous systemic immunosuppressive therapy within 3 months prior to screening; 4. Presence of active bleeding in internal organs, or a severe tendency to bleed, or requiring anticoagulant therapy (including heparin, aspirin, and other medications); 5. Diagnosed with secondary gout or diagnosed or suspected to have rheumatoid arthritis, infectious/septic arthritis, or other acute inflammatory arthritis; presence of other diseases that may confound the assessment of affected joints, such as other sources of pain, including but not limited to neurological diseases, nerve root compression caused by intervertebral disc herniation, shingles, sciatica, etc.; 6. History of severe immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibody; or other acquired or congenital immunodeficiency diseases; 7. Presence of the following clinically significant diseases: (1) Congestive heart failure (New York Heart Association [NYHA] functional class II-IV); (2) Severe arrhythmias requiring class Ia or III antiarrhythmic drugs, or arrhythmias such as sick sinus syndrome, second-degree type II or third-degree atrioventricular block, without a pacemaker implanted; 8. Confirmed active tuberculosis infection: including but not limited to imaging-confirmed active tuberculosis infection; patients with latent TB infection or high-risk factors for TB infection can be enrolled but must exclude those deemed unsuitable by the investigator, such as patients unwilling to continue anti-TB treatment according to local guidelines after entering the trial; 9. Active infection requiring systemic medication within 3 days prior to screening; 10. Receiving dialysis treatment or estimated glomerular filtration rate (eGFR) 5×ULN or aspartate aminotransferase (ALT) >5×ULN; 12. Females with positive blood HCG during screening, breastfeeding females, or those not agreeing to contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the 12-week gout flare recurrence rate;the time to achieve >50% reduction in pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactMeng Qingliang
Henan Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed