Rasburicase Treatment in Chronic Gouty Arthritis

Chronic Gout Clinical Trial

Official title:

Efficacy and Safety of Rasburicase in the Treatment of Chronic Gouty Arthritis: A Multicenter Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312268
• Other study ID #: 2021-KY-097-001
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2022
• Est. completion date: April 15, 2025

Study information

• Verified date: April 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Qianhua Li, M.D.&Ph.D
• Phone: 862081332572
• Email: liqianhua[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty
• Chronic Gout

Intervention

Drug:
• Rasburicase
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.

Locations

Country	Name	City	State
China	Shunde Hospital of Southern Medical University	Foshan	Guangdong
China	Panyu Central Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Shenshan Medical Center	Shanwei	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monosodium urate crystal volume change evaluated by dual energy CT	Dual energy CT at baseline, week 12 and week 24	Baseline to week 12 and week 12 to week 24
Secondary	Tophus volume change evaluated by physical examination		Baseline to week 12 and week 12 to week 24
Secondary	The percentage of patients who have at least one tophi disappeared		Baseline to week 12 and week 12 to week 24
Secondary	The percentage of patients who had achieved serum urate concentrations less than 300 µmol/L (5mg/dl) after 3 months of rasburicase treatment		Baseline to week 12 and week 12 to week 24
Secondary	Number of gout flare		Baseline to week 12 and week 12 to week 24
Secondary	Change of patient global assessment	The patient global assessment is given as a single question, scored from 0-10, with higher numbers representing worse perceived disease activity or overall health.	Baseline to week 12 and week 12 to week 24
Secondary	Change of physician global assessment	The physician global assessment is given as a single question, scored from 0-10, with higher numbers representing worse perceived disease activity or overall health.	Baseline to week 12 and week 12 to week 24
Secondary	Change of Visual Analog Scale (VAS) for Pain in gout flare	Visual Analog for Pain consists of a horizontal line, usually 100mm in length. The left end of the line signifies no pain while the right end signifies the worst possible pain.	Baseline to week 12 and week 12 to week 24
Secondary	Change of global functional status	The criteria are as follows: class I = able to perform usual activities of daily living (self-care, vocational, and avocational); class II = able to perform usual self-care and vocational activities, but limited in avocational activities; class III = able to perform usual self-care activities but limited in vocational and avocational activities; class IV = limited in ability to perform usual self-care, vocational, and avocational activities.	Baseline to week 12 and week 12 to week 24
Secondary	Change of Short Form 12 health survey score		Baseline to week 12 and week 12 to week 24
Secondary	Change of Tophus Impact Questionnaire (TIQ)-20 score		Baseline to week 12 and week 12 to week 24
Secondary	Adverse event		Baseline to week 12 and week 12 to week 24
Secondary	Severe adverse event		Baseline to week 12 and week 12 to week 24
Secondary	Number of patients who have positive anti-rasburicase antibodies		Baseline to week 12 and week 12 to week 24