Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2022-06-15
2025-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Study of Genakumab for Injection in Patients With Acute Gout
NCT05328531
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
NCT05119686
A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
NCT05936281
Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
NCT05936268
A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.
NCT06270225
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks.
Rasburicase
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
Group B
Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks.
Rasburicase
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rasburicase
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qianhua Li, M.D.&Ph.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Panyu Central Hospital
Guangzhou, Guangdong, China
Shenshan Medical Center
Shanwei, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bin Yang, M.D.&Ph.D
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-KY-097-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.