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GOUT: Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit

Sponsor
Lille Catholic University (Other)
Overall Status
Completed
CT.gov ID
NCT03162341
Collaborator
Horizon Pharma Rheumatology LLC (Industry)
60
Enrollment
3
Locations
1
Arm
51
Actual Duration (Months)
20
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this research is to evaluate the correlation between DECT and US explorations performed in a routine clinical setting for the measurement of change in tophus size in gout patients after 24 months of treatment.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ultrasonography
  • Procedure: DECT
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit in Urate Lowering Therapy Initiators
Actual Study Start Date :
Aug 10, 2017
Actual Primary Completion Date :
Nov 8, 2021
Actual Study Completion Date :
Nov 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: UltraSonography and DECT

UltraSonography and DECT will be used in patient monitoring after 6, 12 and 24 months of treatment in order to evaluate the correlation between the 2 explorations for the measurement in tophus volume change. Those are interventions that are not part of the standard care of the patients.

Procedure: ultrasonography
The tophus volume will be assess using ultrasonography.

Procedure: DECT
The tophus volume will be assess using dual-energy computed tomography (DECT).
Other Names:
  • dual-energy computed tomography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between US and DECT measurement of change in tophus volume [after 24 months of treatment]

      Spearman rank correlation between the change in tophus volume after 24 months of treatment measured by ultrasonography or by DECT.

    Secondary Outcome Measures

    1. Correlation between US and DECT measurement of change in tophus volume [after 6 months, 12 months and 24 months of treatment]

      Spearman rank correlation between the change in tophus volume after 6, 12 and 24 months of treatment measured by ultrasonography or by DECT.

    2. Change of DECT urate score [after 6 months, 12 months and 24 months of treatment]

      Change from baseline after 6, 12 and 24 months of treatment in DECT urate score

    3. Link between the change of DECT urate score and the persistence of the double contour sign [after 6 months, 12 months and 24 months of treatment]

      During ultrasonography, a double contour of the articulation can be visible. This outcome will compare the change in the DECT urate score between the patients for who the double contour stay visible and those for who it disapear. This outcome register if this double contour stay visible.

    4. Correlation between the change of DECT urate score and the change in serum uric acid levels [after 6 months, 12 months and 24 months of treatment]

      The Spearman correlation between the change from baseline of the DECT urate score and the serum uric acid levels will be computed for each time point.

    5. Correlation between the change of DECT urate score and the number of gout attacks [after 6 months, 12 months and 24 months of treatment]

      The Spearman correlation between the change from baseline of the DECT urate score and the number of gout attack will be computed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • diagnosis of gout based on the ACR/EULAR 2015 criteria

    • uricemia ≥6 mg/dL

    • warranted introduction of urate-lowering therapy according to the ACR 2012 or EULAR 2016 criteria

    • signature of the informed consent

    • social insurance affiliation

    Exclusion Criteria:

    • pregnancy or breastfeeding

    • patient under legal guardianship

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Group of the Catholic Institute Lomme France 59462
    2 Bichat Hospital Paris France 75018
    3 Lariboisière Hospital Paris France 75475

    Sponsors and Collaborators

    • Lille Catholic University
    • Horizon Pharma Rheumatology LLC

    Investigators

    • Study Director: Tristan Pascart, MD, Hospital Group of the Catholic Institute of Lille
    • Principal Investigator: Sébastien Ottaviani, MD, Bichat Hospital of Paris
    • Principal Investigator: Pascal Richette, MD PhD, Lariboisiere Hospital of Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lille Catholic University
    ClinicalTrials.gov Identifier:
    NCT03162341
    Other Study ID Numbers:
    • RC-P0056
    First Posted:
    May 22, 2017
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lille Catholic University
    Dual-Energy Computed Tomography
    UltraSonography
    Gout
    Urate deposition

    Study Results

    No Results Posted as of Apr 7, 2022