Rasburicase Treatment in Chronic Gouty Arthritis

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Gout
• Intervention / Treatment: Drug: Rasburicase

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qianhua Li, M.D.&Ph.D; Phone Number: 862081332572; Email: liqianhua@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China
      • Not yet recruiting
      • Shunde Hospital of Southern Medical University
      • Contact: Bin Yang, M.D.&Ph.D; Phone Number: 2075722318000
      • Principal Investigator: Bin Liu, M.D.&Ph.D
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Li Qianhua; Phone Number: 862081332572; Email: sumsliqianh@163.com
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Panyu Central Hospital
      • Contact: Haijun Liu, M.D.&Ph.D; Phone Number: 862034858888; Email: kayjun0753@126.com
      • Principal Investigator: Haijun Liu, M.D.&Ph.D
    • Shanwei, Guangdong, China, 516600
      • Not yet recruiting
      • Shenshan Medical Center
      • Contact: Yingqian Mo, M.D.&Ph.D; Phone Number: 866603863000; Email: moyingq@mail.sysu.edu.cn
      • Principal Investigator: Yingqian Mo, M.D.&Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks.	Drug: Rasburicase; Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
Other: Group B; Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks.	Drug: Rasburicase; Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tophus volume change evaluated by physical examination		Baseline to week 12 and week 12 to week 24
The percentage of patients who have at least one tophi disappeared		Baseline to week 12 and week 12 to week 24
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
Number of gout flare		Baseline to week 12 and week 12 to week 24
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
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
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
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
Change of Short Form 12 health survey score		Baseline to week 12 and week 12 to week 24
Change of Tophus Impact Questionnaire (TIQ)-20 score		Baseline to week 12 and week 12 to week 24
Adverse event		Baseline to week 12 and week 12 to week 24
Severe adverse event		Baseline to week 12 and week 12 to week 24
Number of patients who have positive anti-rasburicase antibodies		Baseline to week 12 and week 12 to week 24

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Qianhua Li, M.D.&Ph.D, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Anticipated): October 15, 2024
• Study Completion (Anticipated): April 15, 2025

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Rasburicase; Chronic gouty arthritis
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis; Arthritis, Gouty; Antirheumatic Agents; Gout Suppressants; Rasburicase
• Other Study ID Numbers: 2021-KY-097-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No