Clincosm LogoSign in Get a demo

ActiNG: NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares

Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05744297
Collaborator
(none)
10
Enrollment
1
Location
4.9
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. NLRP3 inflammasome activation in white blood cells. [Patient admission at hospital]

      White blood cells will be isolated from blood sample and NLRP3 inflammasome activation will be assessed by flow cytometry.

    Secondary Outcome Measures

    1. NLRP3 inflammasome activation in synovial cells. [Patient admission at hospital]

      Nucleated cells will be isolated from synovial fluid sample and NLRP3 inflammasome activation will be assessed by flow cytometry.

    2. Effects of NLRP3 inflammasome inhibitors on proportion of NLRP3 inflammasome activation in white blood cells/synovial cells [After analysis of NLRP3 activity]

      NLRP3 inflammasome inhibitors will be tested on cells with NLRP3 inflammasome activity in blood or synovial fluid.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Saint Joseph Saint Luc Lyon France 69007

    Sponsors and Collaborators

    • Centre Hospitalier Saint Joseph Saint Luc de Lyon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Saint Joseph Saint Luc de Lyon
    ClinicalTrials.gov Identifier:
    NCT05744297
    Other Study ID Numbers:
    • ActiNG
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gout

    Study Results

    No Results Posted as of Feb 27, 2023