NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares (ActiNG)

May 11, 2023 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69007
        • Recruiting
        • Centre Hospitalier Saint Joseph Saint Luc
        • Contact:
        • Principal Investigator:
          • Julien Seiller, MD
        • Sub-Investigator:
          • Daniel Liens, MD
        • Sub-Investigator:
          • Charles Burtin, MD
        • Sub-Investigator:
          • Anais Guiot, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study will be proposed to patients meeting study's criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NLRP3 inflammasome activation in white blood cells.
Time Frame: Patient admission at hospital
White blood cells will be isolated from blood sample and NLRP3 inflammasome activation will be assessed by flow cytometry.
Patient admission at hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NLRP3 inflammasome activation in synovial cells.
Time Frame: Patient admission at hospital
Nucleated cells will be isolated from synovial fluid sample and NLRP3 inflammasome activation will be assessed by flow cytometry.
Patient admission at hospital
Effects of NLRP3 inflammasome inhibitors on proportion of NLRP3 inflammasome activation in white blood cells/synovial cells
Time Frame: up to 7 days after analysis of NLRP3 activity
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ActiNG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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