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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05744297
Other study ID # ActiNG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 28, 2023
Est. completion date October 2023

Study information

Verified date February 2023
Source Centre Hospitalier Saint Joseph Saint Luc de Lyon
Contact Julien Seiller, MD
Phone 478 617 757
Email jseiller@chsjsl.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Gout is a chronic joint disease associated with deposition of monosodium urate crystals, as a consequence of hyperuricemia. Gout is an intermittent flaring condition and acute gout flares are driven by NLRP3 inflammasome and IL1-beta production. However pathogenesis of acute gout flares remains poorly known in vivo in human. The aim of this study is to evaluate NLRP3 inflammasome activation in vivo in patients cells during acute gout flares.


Description:

Blood and synovial fluid will be obtained from remainder of patients' samples during an acute gout flares. White blood cells will be isolated and NLRP3 inflammasome activation will be assessed. Then, NLRP3 inflammasome inhibitors will be tested on cells with NLRP3 inflammasome activity.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date October 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hospitalization for acute gout flare confirmed by joint fluid analysis or Nijmegen score > 8 - Aged > 18 Exclusion Criteria: - Gout treatment already started - Inflammatory Arthritis other than Gout Arthritis - Pregnant or breast feeding women - Patient protected by law

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Saint Joseph Saint Luc Lyon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary NLRP3 inflammasome activation in white blood cells. White blood cells will be isolated from blood sample and NLRP3 inflammasome activation will be assessed by flow cytometry. Patient admission at hospital
Secondary NLRP3 inflammasome activation in synovial cells. Nucleated cells will be isolated from synovial fluid sample and NLRP3 inflammasome activation will be assessed by flow cytometry. Patient admission at hospital
Secondary Effects of NLRP3 inflammasome inhibitors on proportion of NLRP3 inflammasome activation in white blood cells/synovial cells NLRP3 inflammasome inhibitors will be tested on cells with NLRP3 inflammasome activity in blood or synovial fluid. up to 7 days after analysis of NLRP3 activity
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