Time Required to Dissolve Urate Deposits
ConditionGout
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Gout patient managed according to a T2T (treat to target) strategy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard X-Rays
Diagnostic test\- Standard X-Rays: feet (Month 0)
Ultrasound
Diagnostic test\- 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
Diagnostic testDECT of feet: in tophaceous patients only (Month 0, Month 24)
DNA sample
Biological/VaccineDNA will be collected at Month 0
Serum collection
Biological/Vaccine\- 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Gout patients treated according to a Treat-to-Dissolve strategy5 interventions
Trial outcomes
Primary outcomes
1
Time required for complete dissolution of urate deposits
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
Time frame
Change between baseline (month 0) and up to 48 months after initiation of ULTSecondary outcomes
1
Number of flares
Flares is defined when 3 of the following 4 criteria are present: * Patient-defined flare * Pain at rest greater than 3 on a 0-10 point numerical rating scale. * Presence of at least one swollen joint. * Presence of at least one hot joint.
Time frame
At Month 0, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 482
Health status as assessed by the EQ-5D-3L questionnaire
Health status as assessed by the EQ-5D-3L descriptive system comprising the following five dimensions: * Mobility, * Self-care, * Usual activities, * Pain/discomfort * Anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the most appropriate box. This decision results into a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame
At Month 0, Month 6, Month 12, Month 24, Month 36, Month 483
Patient self-rated health on a vertical visual analogue scale (EQ VAS)
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, with 100 being the best health and 0 corresponding to the worst health.
Time frame
At Month 0, Month 6, Month 12, Month 24, Month 36, Month 484
Health status as assessed by the HAQ-ID questionnaire
The questionnaire includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 4 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8. The score obtained ranges from 0 to 3. The higher the score, the worse the state of health.
Time frame
At Month 0, Month 6, Month 12, Month 24, Month 36, Month 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
ART VIGGO Association for Research
Collaborator
Source ClinicalTrials.gov