Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

January 29, 2024 updated by: Swamy Venuturupalli, Attune Health Research, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

8

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Attune Health Research Inc.

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

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Adult patients with gout diagnosed by a Rheumatologist.
  2. patients with a history of at least two gout attacks in the target joint
  3. 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).

Exclusion Criteria:

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

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals with Gout
This arm will be getting a biopsy as well as a blood draw
Procedure: Joint Biopsy
a synovial biopsy of a joint that has been affected by a gout attack
Controls
These individuals will not be getting a joint biopsy and will just get a blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NLRP3 Inflammasome Role in Driving Inflammation in Intercritical Gout
Time Frame: Up to 2 months
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.
Up to 2 months
IL-1B Role in Driving Inflammation in Intercritical Gout
Time Frame: Up to 2 months
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.
Up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microcrystal Correlation
Time Frame: Up to 2 months
Correlate NLRP3 activity with the presence of microcrystals in the synovium
Up to 2 months
Immune Cell Infiltration in the Inflamed Joint Correlation
Time Frame: Up to 2 months
Correlate NLRP3 activity with the presence of infiltration of immune cells in the inflamed joint as determined by flow cytometry and cytology
Up to 2 months
Uric Acid Levels Correlation
Time Frame: Up to 2 months
Correlate NLRP3 activity with the concentration of uric acid levels in mg/dL
Up to 2 months

Collaborators and Investigators

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

Sponsor

Attune Health Research, Inc.

Collaborators

Horizon Pharma Ireland, Ltd., Dublin Ireland

Investigators

  • Principal Investigator: Swamy Venuturupalli, MD, Attune Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 22, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Estimated)

March 3, 2024

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36549

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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