Gout
Conditions
Interventions
IL-1 inhibitor group:Firsekibart + uric acid-lowering drugs
Traditional treatment group:Colchicine, NSAIDs , or hormones
uric acid-lowering therapy
Sponsors
Tianjin Medical University Chu Hsien-I Memorial Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Those who are willing to sign the informed consent form and voluntarily cooperate in completing the trial according to the protocol; 2. 18 years old = 2 times/year, continuous growth of tophi; patients have contraindications to NSAIDs and/or colchicine, or are intolerant, or lack efficacy.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Those currently participating in an interventional clinical trial; 3. Any other situation that the researcher deems unsuitable for participation in this study. Exclusion criteria for the IL-1 inhibitor treatment group: 1. Within the past 12 weeks before enrollment, cumulative treatment with >= 5 mg/d prednisone (or equivalent corticosteroids) for more than 28 days or continuous treatment for 14 days; 2. Within the past 30 days before enrollment or within 3 half-lives (whichever is longer), use of any IL-1 blocker, TNF inhibitor, or other biological agents; 3. Continuous use of systemic immunosuppressants for more than 3 months before enrollment. Diagnosis or suspected rheumatoid arthritis, infection/septic arthritis, other diseases that may confuse the assessment of affected joints, such as other pain, including but not limited to neurological diseases, nerve root compression caused by intervertebral disc protrusion, herpes zoster, sciatic neuralgia, etc.; 4. Within the past 7 days before enrollment, need to control infection with systemic medication; 5. Within 3 months before enrollment, received live or attenuated live vaccines, or planned to receive live or attenuated live vaccines during the study; 6. Within 2 weeks before enrollment, received the COVID-19 vaccine; 7. Within 5 years before enrollment, had cancer, excluding skin basal cell carcinoma or stage I squamous cell carcinoma that had been fully treated or removed; 8. Previously received systemic irradiation or total lymphoid irradiation treatment; previously received stem cell treatment or any type of bone marrow transplantation; previously received solid organ transplantation; long-term systemic use of immunosuppressants; 9. Have a severe history of immunodeficiency, including: positive human immunodeficiency virus (HIV) antibody; or other acquired or congenital immune deficiency diseases; 10. Have the following clinically significant diseases: chronic congestive heart failure history, NYHA class IV cardiac function; history of ultrasound echocardiography showing cardiac ejection fraction (EF) lower than 30%; having had myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonary embolism within 6 months; having undergone coronary artery revascularization surgery within 6 months; having severe arrhythmias requiring Ia or III class anti-arrhythmic drug treatment; having sick sinus syndrome, second-degree type II or third-degree atrioventricular block arrhythmia, and not yet implanted with a pacemaker; 11. Confirmed active tuberculosis infection: including but not limited to imaging-confirmed active tuberculosis infection; 12. Undergoing kidney dialysis; 13. Laboratory test values have the following abnormalities: white blood cell count or absolute neutrophil count is lower than the normal limit of the research center; PLT 1.5×ULN, alanine aminotransferase AST) > 3×ULN, aspartate aminotransferase (ALT) > 3×ULN; estimated glomerular filtration rate (eGFR) 5.6mmol/L. 14. Do not agree to use adequate and effective contraceptive measures from signing the informed consent form to 6 months after medication use. 15. Used study drugs within 1 month or participated in other clinical trials within 1 month; 16. Have a history of drug abuse and/or alcoholism or mental disorder; 17. Judged by the researcher, the subject has a situation unsuitable for participation in th
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Complete blood cell analysis;Blood uric acid;C-reactive protein; | — |
Countries
China
Contacts
Public ContactMingzhen Li
Tianjin Medical University Chu Hsien-I Memorial Hospital
Outcome results
None listed