Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT05312268
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be obtained before any assessment is performed, able to understand and comply with the requirements of the study;
* Male and female patients 18 to 70 years of age;
* Fulfill the ACR/EULAR 2015 gout classification criteria;
* Tophi detected by physical examination;
* Serum urate\>300μmol/L (5mg/dl) after one-month maximum dose of urate-lowering therapy (allopurinol 600mg/d or febuxostat 80mg/d in combination with benzbromarone 100mg/d) unless intolerable OR no reduction in size of tophi after serum urate\<300μmol/L (5mg/dl) for six month;
Exclusion Criteria:
* Pregnant women, lactating women, and men or women who have recently prepared for pregnancy;
* Abnormal liver function with AST, ALT, and GGT \>3 times ULN;
* Blood WBC\<4.0×10\^9/L, and/or hemoglobin \<90g/L, and/or platelets;\<100×10\^9/L; or other hematologic disorders;
* eGFR\<15 ml/min;
* Receive following medications: azathioprine, mercaptopurine, cyclosporine, pyrazinamide, ethambutol and sulfamethoxazole
* Psychiatric disorders, history of alcoholism, drug or other substance abuse
* Immunodeficiency diseases, uncontrolled infection, etc;
* Sericosis, glucose-6-phosphate dehydrogenase activity deficiency
* Allergy to biological agents and chronic active urticaria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05312268
Study Brief:
Protocol Section:
NCT05312268