gouty arthritis in patients with chronic kidney disease (CKD stage 3-5)
Conditions
Interventions
Cohort 1: Subcutaneous injection of 200mg of Firsekibart:None
Cohort 2: intramuscular injection of 7mg of compound betamethasone:None
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years, regardless of gender; 2. Body Mass Index (BMI) < 40 kg/m^2; 3. Patients diagnosed with primary gout according to the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria; 4. Current acute gout attack occurred within 5 days prior to the screening period; 5. Patients clinically diagnosed with chronic kidney disease (CKD), with eGFR < 60mL/min/1.73m^2 (calculated using the CKD-EPI formula); 6. Willing to decide on urate-lowering therapy (ULT) during the study based on the investigator’s judgment; 7. Subjects who voluntarily sign the informed consent form and cooperate with the completion of the protocol;
Exclusion criteria
Exclusion criteria: 1. Diagnosis or suspected rheumatoid arthritis, infection/septic arthritis, presence of other diseases that may confound the assessment of the affected joint, such as the presence of other pain, including but not limited to neurological disease, nerve root compression caused by herniated disc, herpes zoster, sciatica, etc.; 2. Presence of the following clinically significant diseases: (1) Those with a history of chronic congestive heart failure and cardiac function NYHA class IV; Those with a history of echocardiography with cardiac ejection fraction (EF) less than 30%; (2) Myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonary embolism within 3 months; (3) Coronary revascularization within 6 months; (4) Presence of severe arrhythmias requiring treatment with class Ia or III antiarrhythmic drugs; Those with sinus syndrome, second-degree type II, or third-degree atrioventricular block arrhythmias who have not yet been implanted with a pacemaker; (5) Those with a QTc interval of >=480ms (according to Fridericia's correction formula, where QTc=QT/(RR^0.33)) during the screening period), or have a history of QTc prolongation; 3. The following abnormalities are present in the laboratory examination values of the elective period: (1) White blood cell count or absolute neutrophil value lower than the lower limit of normal detection by the research center; (2) PLT1.5×ULN, alanine aminotransferase (AST) >3×ULN, aspartate aminotransferase (ALT) >3×ULN; (4) Triglycerides> 5.7mmol/L; 4. Those who have received any of the following medications or therapeutic measures: (1) Receiving other anti-gout treatments such as NSADs, colchicine, hormones, etc. 1 day before enrollment; (2) Use of any IL-1 blockers, TNF inhibitors, other biologics within 30 days or 3 half-lives (whichever is longer, or as required by local regulations) prior to screening; (3) Continuous use of systemically administered glucocorticoids and/or immunosuppressants within 3 months prior to screening; (4) Infection requiring systemic medication control within 7 days prior to screening; 5. Those who meet one of the following conditions: (1) Confirmed diagnosis of active tuberculosis infection: including but not limited to active tuberculosis infection confirmed by imaging; (2) Patients who are in the latent stage of tuberculosis infection or have high-risk factors for tuberculosis infection can be enrolled, but patients who are not suitable for enrollment in the investigator's opinion should be excluded, such as those who are unwilling to continue to receive anti-TB therapy according to local guidelines after entering the trial; 6. Received live or live attenuated vaccines within 3 months prior to screening, or planned to receive live or live attenuated vaccines during the study; 7. History of severe immunodeficiency, including: positive human immunodeficiency virus (HIV) antibody; or other acquired or congenital immunodeficiency diseases; 8. Active malignancy; 9. Previous total body irradiation or total lymphatic irradiation therapy; Previous stem cell therapy or any type of bone marrow transplantation; Previous solid organ transplantation; Systemic long-term immunosuppressant therapy; 10. Use of investigational drugs or participation in other clinical trials within 1 month before screening; 11. Women with positive blood HCG during the screening period, lactating women, and women who cannot use effective contraception during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who had at least one recurrence of gout within 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of IL-6;Changes of hs-CRP;Changes of IL-1ß;Pain score;Changes of serum amyloid protein (SAA); | — |
Countries
China
Contacts
Public ContactXiaoyan Zhang
Zhongshan Hospital, Fudan University
Outcome results
None listed