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DECT Study in Allopurinol-Treated Gout Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393560
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
The purpose of this study is to determine presence and volume of monosodium urate (MSU) crystal deposits as determined by dual-energy computed tomography (DECT) imaging in gout subjects treated with allopurinol with and without visible tophi.

Condition or disease Intervention/treatment
Gout Procedure: DECT scan

Detailed Description:

DECT is a technique that enables visualization of MSU crystal deposits by analysis of the chemical composition of the scanned materials. This study will determine the extent of MSU crystal volume in the hands/wrists, feet/ankles, and knees as determined by DECT of subjects with gout taking a dose of at least 300 mg allopurinol daily for the past 12 weeks.

Patients with gout on allopurinol with and without tophi to be assessed using DECT imaging for crystal deposition with assessments, which include patient and provider assessments of disease severity and pain, prior to and after the scan.

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Study Type : Observational
Actual Enrollment : 223 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Study to Determine the Presence and Volume of Monosodium Urate Crystals as Assessed by Dual-Energy Computed Tomography in Gout Patients Treated With Allopurinol
Study Start Date : April 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Allopurinol

Group/Cohort Intervention/treatment
Gout subjects on stable dose of allopurinol (at least 300mg) Procedure: DECT scan



Primary Outcome Measures :
  1. Presence and volume of MSU crystal deposits as determined by DECT imaging [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Joint erosion as visualized on DECT images [ Time Frame: 8 weeks ]

Biospecimen Retention:   Samples With DNA
Whole blood sample may be used for optional genetic testing in subjects who give consent. Serum aliquots will be collected and may be used for the analysis of potential analytes and biomarkers, but may not be used for genetic testing without the subject's written consent.


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.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Gout subjects taking a stable dose of at least 300 mg allopurinol daily for at least 12 weeks prior to Day 1 as the sole urate-lowering therapy
Criteria

Inclusion Criteria:

  • Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
  • Subject is willing to adhere to the visit/protocol schedules.
  • Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
  • Subject has been taking allopurinol at a dose of at least 300 mg daily for at least 12 weeks prior to Day 1, as the sole uratelowering therapy.

Exclusion Criteria:

  • Subject who is pregnant or breastfeeding.
  • Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements (including dual energy computed tomography imaging), or to complete the study.
  • Subject who has received an investigational therapy or has participated in any clinical trial or research study within 30 days of Day 1.
  • Subject who has taken pegloticase (KRYSTEXXA®) or is expected to take pegloticase during the study.

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): NCT02393560


Locations
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United States, California
Irvine, California, United States, 92618
United States, Colorado
Englewood, Colorado, United States, 80113
Wheat Ridge, Colorado, United States, 80033
United States, Georgia
Atlanta, Georgia, United States, 30328
United States, Ohio
Cleveland, Ohio, United States, 44122
Lyndhurst, Ohio, United States, 44124
Willoughby Hills, Ohio, United States, 44094
United States, Texas
Dallas, Texas, United States, 75231
Plano, Texas, United States, 75075
New Zealand
Grafton, Auckland, New Zealand, 1023
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: Nihar Bhakta, MD Ardea Biosciences, Inc.
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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02393560    
Other Study ID Numbers: ALLO-402
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases