Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

NCT04125459 | Active Not Recruiting

• 1 other identifier: 36549
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 2 months

• 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.

  Up to 2 months

Secondary Outcomes (3)

• Microcrystal Correlation

  Up to 2 months

• Immune Cell Infiltration in the Inflamed Joint Correlation

  Up to 2 months

• Uric Acid Levels Correlation

  Up to 2 months

Study Arms (2)

Individuals with Gout

This arm will be getting a biopsy as well as a blood draw

Procedure: Joint Biopsy

Controls

These individuals will not be getting a joint biopsy and will just get a blood draw

Interventions

Joint Biopsy PROCEDURE

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

Individuals with Gout

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Attune Health Research Inc.

Beverly Hills, California, 90211, United States

Location

Related Publications (26)

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Biospecimen

Retention: SAMPLES WITH DNA

The types of biospecimen collected will be 3-8 synovial tissue samples (from the ultrasound-guided synovial biopsy), as well as 60 mL of peripheral blood.

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Swamy Venuturupalli, MD

  Attune Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder of Attune Health, Attending Rheumatologist at Cedar Sinai Medical Center, Associate Clinical Professor of Medicine at UCLA

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 14, 2019
• Study Start: January 22, 2020
• Primary Completion: March 1, 2021
• Study Completion: October 3, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)