NCT05312268

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2022

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

May 9, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

March 16, 2022

Last Update Submit

May 8, 2023

Conditions

Chronic Gout

Keywords

Chronic gouty arthritisRasburicase

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • 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

    Baseline to week 12 and week 12 to week 24

  • +8 more secondary outcomes

Study Arms (2)

Group A

OTHER

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

Drug: Rasburicase

Group B

OTHER

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

Drug: Rasburicase

Interventions

RasburicaseDRUG

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

Group AGroup B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Shunde Hospital of Southern Medical University

Foshan, Guangdong, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Panyu Central Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Shenshan Medical Center

Shanwei, Guangdong, 516600, China

NOT YET RECRUITING

MeSH Terms

Interventions

rasburicase

Study Officials

  • Qianhua Li, M.D.&Ph.D

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianhua Li, M.D.&Ph.D

CONTACT

862081332572liqianhua@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 5, 2022

Study Start

June 15, 2022

Primary Completion

October 15, 2024

Study Completion

April 15, 2025

Last Updated

May 9, 2023

Record last verified: 2023-04

Locations

CN(4)