Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

Attune Health Research

Status: Active, not recruiting

Conditions: Gout

Treatments: Procedure: Joint Biopsy

Study type: Observational

Funder types: Industry

Identifiers

NCT04125459

36549

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

8 participants in 2 patient groups

Individuals with Gout

Description:

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

Treatment:

Procedure: Joint Biopsy

Controls

Description:

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