Gout ArthritisActiNGNCT05744297
NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares
An observational study of Gout Arthritis, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout Arthritis
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2023to Oct 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study will be proposed to patients meeting study's criteria
Who may be able to join
- Hospitalization for acute gout flare confirmed by joint fluid analysis or Nijmegen score > 8
- Aged > 18
Who cannot join
- Gout treatment already started
- Inflammatory Arthritis other than Gout Arthritis
- Pregnant or breast feeding women
- Patient protected by law
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Julien Seiller, MD, jseiller@chsjsl.fr
Julien Seiller, MD
About this study
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.
Read the 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.
- Conditions
- Gout Arthritis
- Medical subject headings
- Arthritis, Gouty
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patient admission at hospital
Secondary outcomes (2)
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.
Measured: Patient admission at hospital
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.
Measured: up to 7 days after analysis of NLRP3 activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start28 Apr 2023
- Primary completionJun 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744297
- Sponsor's protocol ID
- ActiNG
- Acronym
- ActiNG
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NLRP3 Inflammasome Activation Among Patients During Acute Gout Flares
- ClinicalTrials.gov ID
- NCT05744297
- Acronym / sponsor ID
- ActiNG / ActiNG
- Conditions
- Gout Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study will be proposed to patients meeting study's criteria
Key inclusion criteria (2 listed)
- Hospitalization for acute gout flare confirmed by joint fluid analysis or Nijmegen score > 8
- Aged > 18
Key exclusion criteria (4 listed)
- Gout treatment already started
- Inflammatory Arthritis other than Gout Arthritis
- Pregnant or breast feeding women
- Patient protected by law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
NLRP3 inflammasome activation in synovial cells.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout Arthritis, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Seiller, MD (478 617 757 ext. +33, jseiller@chsjsl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NLRP3 inflammasome activation in white blood cells. (time frame: Patient admission at hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.