NCT02393560

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

March 15, 2015

Last Update Submit

January 24, 2017

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

  • Presence and volume of MSU crystal deposits as determined by DECT imaging

    8 weeks

Secondary Outcomes (1)

  • Joint erosion as visualized on DECT images

    8 weeks

Study Arms (1)

Gout subjects on stable dose of allopurinol (at least 300mg)

Procedure: DECT scan

Interventions

DECT scanPROCEDURE
Gout subjects on stable dose of allopurinol (at least 300mg)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Irvine, California, 92618, United States

Location

Unknown Facility

Englewood, Colorado, 80113, United States

Location

Unknown Facility

Wheat Ridge, Colorado, 80033, United States

Location

Unknown Facility

Atlanta, Georgia, 30328, United States

Location

Unknown Facility

Cleveland, Ohio, 44122, United States

Location

Unknown Facility

Lyndhurst, Ohio, 44124, United States

Location

Unknown Facility

Willoughby Hills, Ohio, 44094, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

Unknown Facility

Plano, Texas, 75075, United States

Location

Unknown Facility

Grafton, Auckland, 1023, New Zealand

Location

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.

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nihar Bhakta, MD

    Ardea Biosciences, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2015

First Posted

March 19, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

NZ(1)US(9)