Clinical trial NCT05312268: Rasburicase Treatment in Chronic Gouty Arthritis
Official title: Efficacy and Safety of Rasburicase in the Treatment of Chronic Gouty Arthritis: A Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Gout
Keywords: Chronic gouty arthritis
Rasburicase
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 of treatment with oral urate-lowering therapy.

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.

Primary outcomes:
measure: Monosodium urate crystal volume change evaluated by dual energy CT
timeFrame: Baseline to week 12 and week 12 to week 24
Secondary outcomes:
measure: Tophus volume change evaluated by physical examination
timeFrame: Baseline to week 12 and week 12 to week 24
measure: The percentage of patients who have at least one tophi disappeared
timeFrame: Baseline to week 12 and week 12 to week 24
measure: The percentage of patients who had achieved serum urate concentrations less than 300 μmol/L (5mg/dl) after 3 months of rasburicase treatment
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Number of gout flare
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Change of patient global assessment
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Change of physician global assessment
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Change of Visual Analog Scale (VAS) for Pain in gout flare
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Change of global functional status
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Change of Short Form 12 health survey score
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Change of Tophus Impact Questionnaire (TIQ)-20 score
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Adverse event
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Severe adverse event
timeFrame: Baseline to week 12 and week 12 to week 24
measure: Number of patients who have positive anti-rasburicase antibodies
timeFrame: Baseline to week 12 and week 12 to week 24
Other outcomes:
Locations:
city: Foshan
country: China
facility: Shunde Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Panyu Central Hospital
state: Guangdong
city: Shanwei
country: China
facility: Shenshan Medical Center
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Qianhua Li, M.D.&Ph.D
role: PRINCIPAL_INVESTIGATOR
References: