Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

Sponsor
Attune Health Research, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04125459
Collaborator
Horizon Pharma Ireland, Ltd., Dublin Ireland (Industry)
8
1
34.3
0.2

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Joint Biopsy

Study Design

Study Type:
Observational
Anticipated Enrollment :
8 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Assessing the Role of the NLRP3 Inflammasome in Driving Inflammation in Affected Joints of Patients With Intercritical Gout
Actual Study Start Date :
Jan 22, 2020
Actual Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. NLRP3 Inflammasome Role in Driving Inflammation in Intercritical Gout [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.

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

Secondary Outcome Measures

  1. Microcrystal Correlation [Up to 2 months]

    Correlate NLRP3 activity with the presence of microcrystals in the synovium

  2. Immune Cell Infiltration in the Inflamed Joint Correlation [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

  3. Uric Acid Levels Correlation [Up to 2 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Attune Health Research Inc. Beverly Hills California United States 90211

Sponsors and Collaborators

  • Attune Health Research, Inc.
  • Horizon Pharma Ireland, Ltd., Dublin Ireland

Investigators

  • Principal Investigator: Swamy Venuturupalli, MD, Attune Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Swamy Venuturupalli, Founder of Attune Health, Attending Rheumatologist at Cedar Sinai Medical Center, Associate Clinical Professor of Medicine at UCLA, Attune Health Research, Inc.
ClinicalTrials.gov Identifier:
NCT04125459
Other Study ID Numbers:
  • 36549
First Posted:
Oct 14, 2019
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022