Trials Sponsors Conditions Drugs Pricing

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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;

Sponsors & Collaborators

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

Study Sites (4)

Shunde Hospital of Southern Medical University

Foshan, Guangdong, China

NOT_YET_RECRUITING

Bin Yang, M.D.&Ph.DCONTACT2075722318000

Bin Liu, M.D.&Ph.DPRINCIPAL INVESTIGATOR

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Li QianhuaCONTACT862081332572 sumsliqianh@163.com

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

862081332572 liqianhua@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

Actual (reported)

Primary Completion

October 15, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Rasburicase Treatment in Chronic Gouty Arthritis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Group A

Group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Group A

Group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations