Clinical trial NCT04125459: Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout
Official title: Assessing the Role of the NLRP3 Inflammasome in Driving Inflammation in Affected Joints of Patients With Intercritical Gout
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gout
Lead sponsor: Attune Health Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Horizon Pharma Ireland, Ltd., Dublin Ireland
First posted: 2019-10-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: NLRP3 Inflammasome Role in Driving Inflammation in Intercritical Gout
timeFrame: Up to 2 months
measure: IL-1B Role in Driving Inflammation in Intercritical Gout
timeFrame: Up to 2 months
Secondary outcomes:
measure: Microcrystal Correlation
timeFrame: Up to 2 months
measure: Immune Cell Infiltration in the Inflamed Joint Correlation
timeFrame: Up to 2 months
measure: Uric Acid Levels Correlation
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Attune Health Research Inc.
state: California
Study officials:
affiliation: Attune Health
name: Swamy Venuturupalli, MD
role: PRINCIPAL_INVESTIGATOR
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