Rasburicase Treatment in Chronic Gouty Arthritis

• Status: Not yet recruiting
• Trial end date: 2025-04-15
• Target enrollment: 0
• Participant gender: All

Summary

The study will establish efficacy and safety of rasburicase in chronic gouty arthritis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Rasburicase

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.