NCT05744297

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 28, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 12, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

February 2, 2023

Last Update Submit

May 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • NLRP3 inflammasome activation in synovial cells.

    Patient admission at hospital

  • Effects of NLRP3 inflammasome inhibitors on proportion of NLRP3 inflammasome activation in white blood cells/synovial cells

    up to 7 days after analysis of NLRP3 activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study will be proposed to patients meeting study's criteria

You may qualify if:

  • Hospitalization for acute gout flare confirmed by joint fluid analysis or Nijmegen score \> 8
  • Aged \> 18

You may not qualify if:

  • Gout treatment already started
  • Inflammatory Arthritis other than Gout Arthritis
  • Pregnant or breast feeding women
  • Patient protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and synovial fluid obtained from remainder of samples collected during standard of care required during acute goute flare.

MeSH Terms

Conditions

Arthritis, Gouty

Condition Hierarchy (Ancestors)

GoutArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Julien Seiller, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 27, 2023

Study Start

April 28, 2023

Primary Completion

June 1, 2023

Study Completion

October 1, 2023

Last Updated

May 12, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations