Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout

Gout Flare Clinical Trial

Official title:

Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05522504
• Other study ID #: SHSY-IEC-4.1/21-246/01
• Status: Active, not recruiting
• Start date: September 15, 2022
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate whether immune cells and their subtypes in peripheral blood affects the asymptomatic hyperuricemia, gout flare, intercritical gout and advanced gout.

Description:

A number of studies have reported that innate immunity cells (such as blood monocytes and neutrophils) play a crucial role in the initiation and amplification of gout flare resulted from MSU deposition in the joint or tissue, leading to release NLRP3 inflammasome-mediated production of bioactive IL-1β. Further investigation demonstrated the role of blood neutrophils might contribute to the resolution of gout flare by forming aggregated neutrophil extracellular traps. Recently, a few in vitro experiments have indicated that adaptive immunity may be involved in mechanisms of gout. However, a global understanding of blood immune responses underlying gout is still unclear. Thus, we want to investigate the relationship between immune cells and their subtypes in peripheral blood and the gout.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: February 2025
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• gout flare:diagnosis with gout flare at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015
• intercritical gout: remission of gout patients were classified into intercritical gout group without tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
• advanced gout: gout remission patients were classified into advanced gout group characterized by tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
• asymptomatic hyperuricemia: hyperuricemia in men was defined as SUA = 420 mmol/L without any complications

Exclusion Criteria:

• primary osteoarticular diseases
• unwilling participation in the study
• corticosteroids or indomethacin use in the past 3 months;
• septic arthritis or another joint disease (such as rheumatoid arthritis);
• impaired renal function (creatinine clearance <30 mL/min) and other conditions which may increase the level of blood uric acid

Related Conditions & MeSH terms

• Asymptomatic Hyperuricemia
• Gout
• Gout Flare
• Hyperuricemia
• Intercritical Gout

Locations

Country	Name	City	State
China	Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ai Peng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission of gout	Patients fulfilling all the domains of the 2016 preliminary remission criteria for gout were defined as gout remission group	6 month