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GoutNCT04125459

Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

An observational study of Gout, run by Attune Health Research, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gout is an autoinflammatory disease characterized by flares of painful joint inflammation. This inflammation occurs in response to uric acid that crystallizes. After a gout attack, patients usually enter a period that is accompanied by low grade inflammation but is otherwise relatively asymptomatic. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gout
What is being tested?
Joint Biopsy
Type of treatment
Surgery or procedure
How many people
8 participants
Where
1 siteUnited States
Study dates
22 Jan 2020to 3 Oct 2024
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult patients over the age of 18 diagnosed with intercritical gout who have evidence of inflammation as determined by ultrasound examination will be screened for this study. The control group will comprise of age and sex-matched healthy volunteers. They will be recruited from the private rheumatology practices of Swamy Venuturupalli, MD and Ami Ben-Artzi, MD.

Who may be able to join

  • Adult patients with gout diagnosed by a Rheumatologist.
  • patients with a history of at least two gout attacks in the target joint
  • Patients with a target joint amenable to biopsy. Target joint defined as:
  • Joint that has been affected by acute gout attack at least twice in the 12 months prior to enrollment.
  • Ultrasound finds grade 2 gray-scale synovitis in joint. Joint is amenable to biopsy. At the time of enrollment, the joint is without signs of acute inflammation: redness, swelling, and severe pain (>7/10).

Who cannot join

  • Patients on anti-coagulation therapy.
  • Patients with an active infection.
  • Tophus present at the biopsy site.
  • Target joint with signs of acute gout attack (pain >7/10, redness, warmth)
  • Known chondrocalcinosis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Attune Health Research Inc.

    Beverly Hills, California, 90211

Other trials in United States

About this study

Official title: Assessing the Role of the NLRP3 Inflammasome in Driving Inflammation in Affected Joints of Patients With Intercritical Gout

Gout is an autoinflammatory disease characterized by flares of painful joint inflammation. This inflammation occurs in response to uric acid that crystallizes. After a gout attack, patients usually enter a period that is accompanied by low grade inflammation but is otherwise relatively asymptomatic. Gout is typically associated with certain markers, and this study is going describe specific markers in patients that are in between gout attacks. Research has been focused on studying this phase between gout attacks in hopes to manage and prevent the onset of future gout attacks. Biopsies will be taken from the affected joint and blood will be drawn from patients who are currently in between gout attacks. This work will provide important information regarding how crystals in the joint lining are associated with chronic inflammation in the periods between gout attacks. Moreover, this study will identify novel biomarkers that may be useful in determining the severity of disease activity through a blood test.

Conditions
Gout
Being tested
Joint Biopsy
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Joint BiopsyProcedure or surgery

    a synovial biopsy of a joint that has been affected by a gout attack

Study groups in NCT04125459
Study groupRoleWhat they receive
Individuals with GoutThis arm will be getting a biopsy as well as a blood draw
Receives: Procedure: Joint Biopsy
ControlsThese individuals will not be getting a joint biopsy and will just get a blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NLRP3 Inflammasome Role in Driving Inflammation in Intercritical Gout

    To investigate the role of the NLRP3 inflammasome in driving inflammation in intercritical gout. Specifically, this will be accomplished via measuring caspase-1 activity as a marker of inflammasome activity. We will measure the % of patients who show a %positivity (physiological parameter) of caspase-1 activity.

    Measured: Up to 2 months

  2. IL-1B Role in Driving Inflammation in Intercritical Gout

    Examine the role of IL-1b in driving inflammation within intercritical gout via the measurement of IL-1b levels. IL-1b concentration levels (physiological parameter) will be measured in ng/ml.

    Measured: Up to 2 months

Secondary outcomes (3)

  1. Microcrystal Correlation

    Correlate NLRP3 activity with the presence of microcrystals in the synovium

    Measured: Up to 2 months

  2. Immune Cell Infiltration in the Inflamed Joint Correlation

    Correlate NLRP3 activity with the presence of infiltration of immune cells in the inflamed joint as determined by flow cytometry and cytology

    Measured: Up to 2 months

  3. Uric Acid Levels Correlation

    Correlate NLRP3 activity with the concentration of uric acid levels in mg/dL

    Measured: Up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2019
  2. Study start22 Jan 2020
  3. Primary completion1 Mar 2021
  4. Study completion3 Oct 2024 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04125459
Sponsor's protocol ID
36549
Status last verified
Aug 2024
First submitted
23 Sep 2019
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.

    PubMed 9588729

  • Zhu Y, Pandya BJ, Choi HK. Prevalence of gout and hyperuricemia in the US general population: the National Health and Nutrition Examination Survey 2007-2008. Arthritis Rheum. 2011 Oct;63(10):3136-41. doi: 10.1002/art.30520.

    PubMed 21800283

  • Neogi T, Hunter DJ, Chaisson CE, Allensworth-Davies D, Zhang Y. Frequency and predictors of inappropriate management of recurrent gout attacks in a longitudinal study. J Rheumatol. 2006 Jan;33(1):104-9. Epub 2005 Nov 1.

    PubMed 16267879

  • Burns CM, Wortmann RL. Latest evidence on gout management: what the clinician needs to know. Ther Adv Chronic Dis. 2012 Nov;3(6):271-86. doi: 10.1177/2040622312462056.

    PubMed 23342241

  • Ragab G, Elshahaly M, Bardin T. Gout: An old disease in new perspective - A review. J Adv Res. 2017 Sep;8(5):495-511. doi: 10.1016/j.jare.2017.04.008. Epub 2017 May 10.

    PubMed 28748116

  • Hirsch JD, Terkeltaub R, Khanna D, Singh J, Sarkin A, Shieh M, Kavanaugh A, Lee SJ. Gout disease-specific quality of life and the association with gout characteristics. Patient Relat Outcome Meas. 2010 Mar 1;2010:1-8. doi: 10.2147/PROM.S8310.

    PubMed 21686040

  • Pascual E. Persistence of monosodium urate crystals and low-grade inflammation in the synovial fluid of patients with untreated gout. Arthritis Rheum. 1991 Feb;34(2):141-5. doi: 10.1002/art.1780340203.

    PubMed 1994910

  • Carter JD, Patelli M, Anderson SR, Prakash N, Rodriquez EJ, Bateman H, Sterrett A, Valeriano J, Ricca LR. An MRI assessment of chronic synovial-based inflammation in gout and its correlation with serum urate levels. Clin Rheumatol. 2015 Feb;34(2):345-51. doi: 10.1007/s10067-014-2644-9. Epub 2014 May 7.

    PubMed 24797771

  • Ruggiero C, Cherubini A, Ble A, Bos AJ, Maggio M, Dixit VD, Lauretani F, Bandinelli S, Senin U, Ferrucci L. Uric acid and inflammatory markers. Eur Heart J. 2006 May;27(10):1174-81. doi: 10.1093/eurheartj/ehi879. Epub 2006 Apr 12.

    PubMed 16611671

  • Grainger R, McLaughlin RJ, Harrison AA, Harper JL. Hyperuricaemia elevates circulating CCL2 levels and primes monocyte trafficking in subjects with inter-critical gout. Rheumatology (Oxford). 2013 Jun;52(6):1018-21. doi: 10.1093/rheumatology/kes326. Epub 2012 Nov 30.

    PubMed 23204548

  • Kingsbury SR, Conaghan PG, McDermott MF. The role of the NLRP3 inflammasome in gout. J Inflamm Res. 2011;4:39-49. doi: 10.2147/JIR.S11330. Epub 2011 Mar 13.

    PubMed 22096368

  • Landis RC, Haskard DO. Pathogenesis of crystal-induced inflammation. Curr Rheumatol Rep. 2001 Feb;3(1):36-41. doi: 10.1007/s11926-001-0049-7.

    PubMed 11177769

  • Amaral FA, Costa VV, Tavares LD, Sachs D, Coelho FM, Fagundes CT, Soriani FM, Silveira TN, Cunha LD, Zamboni DS, Quesniaux V, Peres RS, Cunha TM, Cunha FQ, Ryffel B, Souza DG, Teixeira MM. NLRP3 inflammasome-mediated neutrophil recruitment and hypernociception depend on leukotriene B(4) in a murine model of gout. Arthritis Rheum. 2012 Feb;64(2):474-84. doi: 10.1002/art.33355.

    PubMed 21952942

  • Guo H, Callaway JB, Ting JP. Inflammasomes: mechanism of action, role in disease, and therapeutics. Nat Med. 2015 Jul;21(7):677-87. doi: 10.1038/nm.3893. Epub 2015 Jun 29.

    PubMed 26121197

  • Krishnan E, Baker JF, Furst DE, Schumacher HR. Gout and the risk of acute myocardial infarction. Arthritis Rheum. 2006 Aug;54(8):2688-96. doi: 10.1002/art.22014.

    PubMed 16871533

Questions about this trial

What is this clinical trial studying?

An observational study of Gout, run by Attune Health Research, Inc. at 1 site in United States.

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 5 inclusion and 5 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 6 Aug 2024. 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 United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NLRP3 Inflammasome Role in Driving Inflammation in Intercritical Gout (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04125459, which also lists 26 linked publications.

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 6 Aug 2024.

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