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

Gout Clinical Trial

— GOUT  

Official title:

Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit in Urate Lowering Therapy Initiators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162341
• Other study ID #: RC-P0056
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: November 8, 2021

Study information

• Verified date: April 2022
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

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

Locations

Country	Name	City	State
France	Hospital Group of the Catholic Institute	Lomme
France	Bichat Hospital	Paris
France	Lariboisière Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Horizon Pharma Rheumatology LLC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between US and DECT measurement of change in tophus volume	Spearman rank correlation between the change in tophus volume after 24 months of treatment measured by ultrasonography or by DECT.	after 24 months of treatment
Secondary	Correlation between US and DECT measurement of change in tophus volume	Spearman rank correlation between the change in tophus volume after 6, 12 and 24 months of treatment measured by ultrasonography or by DECT.	after 6 months, 12 months and 24 months of treatment
Secondary	Change of DECT urate score	Change from baseline after 6, 12 and 24 months of treatment in DECT urate score	after 6 months, 12 months and 24 months of treatment
Secondary	Link between the change of DECT urate score and the persistence of the double contour sign	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.	after 6 months, 12 months and 24 months of treatment
Secondary	Correlation between the change of DECT urate score and the change in serum uric acid levels	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.	after 6 months, 12 months and 24 months of treatment
Secondary	Correlation between the change of DECT urate score and the number of gout attacks	The Spearman correlation between the change from baseline of the DECT urate score and the number of gout attack will be computed.	after 6 months, 12 months and 24 months of treatment