Status:
UNKNOWN
Rasburicase Treatment in Chronic Gouty Arthritis
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Chronic Gout
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The study will establish efficacy and safety of rasburicase in chronic gouty arthritis
Detailed Description
The study hypothesis is that the proportion of patients who achieved the primary endpoint after 12 weeks of treatment with rasburicase combined with oral urate-lowering therapy is superior to 12 weeks...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05312268
Start Date
June 15 2022
End Date
April 15 2025
Last Update
May 9 2023
Active Locations (4)
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1
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
2
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
3
Panyu Central Hospital
Guangzhou, Guangdong, China
4
Shenshan Medical Center
Shanwei, Guangdong, China, 516600