Time Required to Dissolve Urate Deposits

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

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

DNA sample: DNA will be collected at Month 0

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Time required for complete dissolution of urate deposits — Change between baseline (month 0) and up to 48 months after initiation of ULT
  For each patient, urate deposit dissolution will be monitored by repeated US scans. The US features which will be recorded according to the Outcome Measures in Rheumatology (OMERACT) scoring system: * at MTP1s: the DC sign, tophi and aggregates * at the knees (femoral condyles): the DC sign. The aggregates will only be scored if the DC sign and/or tophus are present and if the aggregates are not located inside a tophus. For each site, the US features will be graded as follows: absent (0) possible (1) moderate (2) important (3). Thus, a score (0-24) will be calculated for each patient. A score of 0 means that there are no longer urate deposits, while a score of 24 means that there are a lot of urate deposits. Dissolution is considered to have been achieved when a score of 0/24 is reached on two successive US scans performed 6 months apart

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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