Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04125459
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
Horizon Pharma Ireland, Ltd., Dublin Ireland
Information provided by (Responsible Party):
Swamy Venuturupalli, Attune Health Research, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Gout Procedure: Joint Biopsy

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Assessing the Role of the NLRP3 Inflammasome in Driving Inflammation in Affected Joints of Patients With Intercritical Gout
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Biopsy Gout

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Individuals with Gout
This arm will be getting a biopsy as well as a blood draw
 Procedure: Joint Biopsy
a synovial biopsy of a joint that has been affected by a gout attack
Controls
These individuals will not be getting a joint biopsy and will just get a blood draw


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
The types of biospecimen collected will be 3-8 synovial tissue samples (from the ultrasound-guided synovial biopsy), as well as 60 mL of peripheral blood.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125459


Contacts
Layout table for location contacts
Contact: Natalie Fortune, MS 4242813653 natalie@attunehealth.com
Contact: Amit Kumar, BS 3106520010 ext 128 amit.kumar@attunehealth.com

Locations
Layout table for location information
United States, California
Attune Health Research Inc. Recruiting
Beverly Hills, California, United States, 90211
Contact: Natalie Fortune, MS    310-652-0010    natalie@attunehealth.com   
Sponsors and Collaborators
Attune Health Research, Inc.
Horizon Pharma Ireland, Ltd., Dublin Ireland
Investigators
Layout table for investigator information
Principal Investigator: Swamy Venuturupalli, MD Attune Health
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Swamy Venuturupalli, Founder of Attune Health, Attending Rheumatologist at Cedar Sinai Medical Center, Associate Clinical Professor of Medicine at UCLA, Attune Health Research, Inc.
ClinicalTrials.gov Identifier: NCT04125459    
Other Study ID Numbers: 36549
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
 Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases