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RecruitingNCT05546593EchoGoutteUpdated Mar 19, 2025

Prevalence of Abnormalities in Ultrasonography of Joint and Tendons in Patients With Gout

An observational study in Gout, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Aug 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in France. This disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. To date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the OMERACT (Outcome Measures in Rheumatology) in 2015. The objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout.

Read the detailed description

Gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in France. This disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. To date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the OMERACT (Outcome Measures in Rheumatology) in 2015. The objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout. This is a transversal bicentric study, including patients who consulted for gout in the Rheumatology and Internal Medicine department of Ambroise Paré Hospital. Inclusion criteria were adult patients with a diagnosis of gout according to ACR/EULAR 2015 criteria and able to give informed consent. Exclusion criteria were the presence of other chronic inflammatory rheumatic diseases and patients without French social insurance. Patients had clinical and ultrasound examination, realized by two physicians blinded from each other.

02

Conditions studied

  • Gout

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Keywords

  • Gout
  • Ultrasound
  • Microcrystal disease
03

In context

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

This study's planned enrollment of 200 is below the median of 232 across 52 observational studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients consulting in Rheumatology or Internal Medicine Departments of Ambroise Paré hospital-APHP.

Inclusion criteria

Inclusion criteria were adult patients with a diagnosis of gout according to ACR/EULAR 2015 criteria and able to give . Exclusion criteria were the presence of other chronic inflammatory rheumatic diseases and patients without French social insurance.

Exclusion criteria

Exclusion Criteria:

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Ultrasound lesion of gout as defined by OMERACT (Outcome Measures in Rheumatology)

    double contour, agreggates, tophi, erosions, synovitis, tenosynovitis and osteophytes

    Time frame: at baseline

07

Study locations

1 of 1 sites recruiting
  • Rhumatology department, Ambroise Paré hospital - APHP
    Boulogne-Billancourt, Aphp 92100, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05546593
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Aug 24, 2022
Primary completion
Mar 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Mar 19, 2025

Study contacts

Maria-Antonietta D'AGOSTINO, MD, PhD
Contact
maria-antonietta.dagostino@aphp.fr
+33 01 49 09 56 74
Hélène Gouze, MD
Contact
helene.gouze@aphp.fr
+33149094674
Maria-Antonietta D'AGOSTINO, MD, PhD
principal investigator · Rhumatology department, Ambroise Paré hospital - APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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