Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
250 participants
OBSERVATIONAL
2024-11-30
2032-11-30
Brief Summary
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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.
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Detailed Description
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In all patients, SUA levels will be lowered with allopurinol or febuxostat (XOI) depending on renal function (eGFR greater or less than 30 ml/mn/m2) or uricosurics, by starting medications at a low dose and subsequent titration. The target SUA levels is less than 40 mg/L in all patients.
Patients will then be monitored by US every 6 months until complete urate crystals dissolution. An ultrasound score (min 0- max 24; 0 meaning no urate deposits and 24 the highest value for quantifying the extent of deposits) will be calculated for each US scan. Dissolution is considered to have been achieved when a score of 0/24 is reached on two successive US scans performed 6 months apart.
The Predictive Factors (clinical, biological, genetic) associated with the complete dissolution of urate deposits will be determined.
DECT (feet) will be performed only in tophaceous patients at M0 and M24. Each patient will receive a capillary urate point of care device for self-urate measurement. Patients will be contacted monthly by nurses for the first 6 months to ensure treatment compliance and SUA target attainment.
Blood samples will be collected at M0, M6, M24 and M36 for omic and epigenetic studies. Clinical data will be collected at M0, M6, M12, M24, M36 and M48. Change in Protein, Epigenetic and omic profils will be determined.
DNA for genetic studies will be collected at M0. Co-morbidities, particularly cardiovascular and hepatic, will be assessed at M6: coronary artery calcium (CAC) scoring and liver fibroscan.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Gout patients treated according to a Treat-to-Dissolve strategy
Patients initiated with ULT (urate target less than 40 mg/L), and followed every 6 months with Ultrasound until complete urate dissolution
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Gout according to the ACR/Eular 2015 criteria
* SUA levels greater than 60 mg/L
* US score (MTP1s, knees) ≥2/24
* Informed consent Dated and signed voluntarily
Exclusion Criteria
* Severe and uncontrolled diseases such as cancer, cardiovascular or neurovegetative diseases
* Pregnant or breast-feeding women
* No affiliation to the French National Social Security System
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
ART VIGGO Association for Research
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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APHP, Lariboisière Hospital, Rheumatology departement
Paris, , France
Countries
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Central Contacts
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Other Identifiers
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2024-A00937-40
Identifier Type: OTHER
Identifier Source: secondary_id
APHP240644
Identifier Type: -
Identifier Source: org_study_id
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