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RECRUITING
NCT06669000

Time Required to Dissolve Urate Deposits

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Gout is characterized by episodes of acute arthritis of the lower limbs due to intermittent activation of innate immunity in the joints where urate crystals have formed. These crystals occur when serum urate (SUA) levels have been above 70 mg/L for many years. They can be dissolved by lowering SUA levels to at least 60 mg/L (treat-to-target - T2T - strategy). Once the crystals are dissolved, patients are no longer symptomatic and are considered to be in remission (treat-to-dissolve - T2D - strategy). The presence of crystals and their dissolution during treatment can be monitored by repeated ultrasound (US) scans of the feet and knees. The time required for complete dissolution varies from patient to patient. ReViGore40 is a cohort designed to i) determine the time to complete dissolution of urate deposits in joints when SUA levels are maintained below 40 mg/L, ii) determine the factors (clinical, biological, genetic) associated with the time required for complete dissolution of urate deposits within joints.

Official title: Time Required to Dissolve Urate Deposits in Patients With Gout

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2024-09-24

Completion Date

2032-09-24

Last Updated

2026-02-19

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Standard X-Rays

\- Standard X-Rays: feet (Month 0)

DIAGNOSTIC_TEST

Ultrasound

\- Ultrasound (score 0-24): assessment for DC (Double Contour) sign (0-3), aggregates (0-3), tophi (0-3) at MTP1s (first metatarsophalangeal joints) and DC sign (0-3) at both knees, according to the OMERACT, every 6 months until complete dissolution of urate deposits.

DIAGNOSTIC_TEST

DECT of feet

DECT of feet: in tophaceous patients only (Month 0, Month 24)

BIOLOGICAL

DNA sample

DNA will be collected at Month 0

BIOLOGICAL

Serum collection

\- Serum will be collected at Month 0, Month 6, Month 12, Month 18, Month 24 , Month 36 and Month 48. For OMICs and epigenetic studies: Month 0, Month 6, Month 24 and Month 36.

Locations (1)

APHP, Lariboisière Hospital, Rheumatology departement

Paris, France