Time Required to Dissolve Urate Deposits in Patients With Gout
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Time required for complete dissolution of urate deposits
研究概览
简要总结
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.
详细描述
Patients with newly diagnosed gout according to the 2015 ACR/Eular criteria, not treated with urate-lowering therapy and with US evidence of urate deposition (feet, knees; ultrasound score ≥ 2/24) will be enrolled in the ReViGore40 cohort.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •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
排除标准
- •Ongoing urate lowering therapy
- •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
研究组 & 干预措施
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
干预措施: Ultrasound (Diagnostic Test)
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
干预措施: Standard X-Rays (Diagnostic Test)
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
干预措施: DECT of feet (Diagnostic Test)
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
干预措施: DNA sample (Biological)
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
干预措施: Serum collection (Biological)
结局指标
主要结局
Time required for complete dissolution of urate deposits
时间窗: 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
次要结局
- Number of flares(At Month 0, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 48)
- Health status as assessed by the EQ-5D-3L questionnaire(At Month 0, Month 6, Month 12, Month 24, Month 36, Month 48)
- Patient self-rated health on a vertical visual analogue scale (EQ VAS)(At Month 0, Month 6, Month 12, Month 24, Month 36, Month 48)
- Health status as assessed by the HAQ-ID questionnaire(At Month 0, Month 6, Month 12, Month 24, Month 36, Month 48)
- Proteins profils(Month 0, Month 6, Month 24, Month 36)