Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04125459
• Other study ID #: 36549
• Status: Active, not recruiting
• Start date: January 22, 2020
• Est. completion date: March 3, 2024

Study information

• Verified date: January 2024
• Source: Attune Health Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: March 3, 2024
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Procedure:
• Joint Biopsy
a synovial biopsy of a joint that has been affected by a gout attack

Locations

Country	Name	City	State
United States	Attune Health Research Inc.	Beverly Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Attune Health Research, Inc.	Horizon Pharma Ireland, Ltd., Dublin Ireland

Country where clinical trial is conducted

United States, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Microcrystal Correlation	Correlate NLRP3 activity with the presence of microcrystals in the synovium	Up to 2 months
Secondary	Immune Cell Infiltration in the Inflamed Joint Correlation	Correlate NLRP3 activity with the presence of infiltration of immune cells in the inflamed joint as determined by flow cytometry and cytology	Up to 2 months
Secondary	Uric Acid Levels Correlation	Correlate NLRP3 activity with the concentration of uric acid levels in mg/dL	Up to 2 months