Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04125459
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Attune Health Research, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Swamy Venuturupalli, MD
Principal Investigator Affiliation Attune Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gout
Arms & Interventions

Arms

: Individuals with Gout

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

: Controls

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

Interventions

Procedure: - Joint Biopsy

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Attune Health Research Inc., Beverly Hills, California

Status

Recruiting

Address

Attune Health Research Inc.

Beverly Hills, California, 90211

Site Contact

Natalie Fortune, MS

[email protected]

310-652-0010