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NCT Number: NCT04125459

Assessing the Role of the NLRP3 Inflammasome in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Attune Health Research Inc.

Beverly Hills, California, 90211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Joint Biopsy

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Microcrystal Correlation

    Time frame: Up to 2 months

    Correlate NLRP3 activity with the presence of microcrystals in the synovium

  2. 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

  3. Uric Acid Levels Correlation

    Time frame: Up to 2 months

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

Sponsors and collaborators

Lead sponsor

Attune Health Research, Inc.

Industry

Collaborators

  • Horizon Pharma Ireland, Ltd., Dublin Ireland

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Oct 14, 2019
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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