Rasburicase Treatment in Chronic Gouty Arthritis

Sun Yat-sen University

Status and phase: Enrolling; Phase 4

Conditions: Chronic Gout

Treatments: Drug: Rasburicase

Study type: Interventional

Funder types: Other

Identifiers

NCT05312268

2021-KY-097-001

Details and patient eligibility

About

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

Full 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 of treatment with oral urate-lowering therapy.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A

Other group

Description:

Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks.

Treatment:

Drug: Rasburicase

Group B

Other group

Description:

Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks.

Treatment:

Drug: Rasburicase