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According to international recommendations, urate lowering therapy (ULT), mainly the xanthine oxidase inhibitors (XOIs) allopurinol and febuxostat, should be prescribed lifelong in gout patients. However, this recommendation comes up against very poor adherence to ULT, since around half of patients stop their treatment at 5 years. Moreover, there is uncertainty about the cardiovascular tolerance of febuxostat taken over the long term. Finally, although XOIs are generally well tolerated, they can cause side effects and require regular biological monitoring. The hypothesis is that the risk of flares following withdrawal of ULT is very low in gout patients when urate store is depleted and repeated ultrasounds (US) do not demonstrate the reappearance of urate deposits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinuation of urate lowering therapy | Experimental |
| |
| Continuation of urate lowering therapy (usual care) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discontibuation of oral ULT | Drug | Patients will stop the ULT at D0. They will have an US scan to look for urate deposits at each visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients experiencing one or more flares | According to the Gaffo's criteria | At 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients experiencing one or more flares | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 6 months |
| Proportion of patients experiencing one or more flares |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Richette, MD PhD | Contact | 1 49 95 86 31 | +33 | pierre.moine@aphp.fr |
| Jérôme Lambert, MD PhD | Contact | 1 42 49 49 60 | +33 | jerome.lambert@u-paris.fr |
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Multicentre, parallel arm, non-blinded randomised controlled non-inferiority clinical trial. Gout patients in remission and no urate deposits as assessed by US will be randomised to i) a maintenance group -ULT will be pursued - or ii) a withdrawal experimental group - discontinuation of ULT -.
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| Maintenance of ULT | Drug | Patients will continue their ULT according to the recommendations of the Eular and French Society of Rheumatology, to maintain their SUA levels below 60 mg/l. |
|
According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)
| At 12 months |
| Proportion of patients experiencing one or more flares | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 18 months |
| Proportion of patients experiencing one or more flares | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 30 months |
| Proportion of patients experiencing one or more flares | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 36 months |
| Mean flare rates | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 6 months |
| Mean flare rates | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 12 months |
| Mean flare rates | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 18 months |
| Mean flare rates | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 24 months |
| Mean flare rates | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 30 months |
| Mean flare rates | According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS) | At 36 months |
| US features of gout at MPT1s | Double contour sign, tophi, aggregates for withdrawal arm | At 6 months |
| US features of gout at MPT1s | Double contour sign, tophi, aggregates for withdrawal arm | At 12 months |
| US features of gout at MPT1s | Double contour sign, tophi, aggregates for withdrawal arm | At 18 months |
| US features of gout at MPT1s | Double contour sign, tophi, aggregates for both arms | At 24 months |
| US features of gout at MPT1s | Double contour sign, tophi, aggregates for withdrawal arm | At 30 months |
| US features of gout at MPT1s | Double contour sign, tophi, aggregates for withdrawal arm | At 36 months |
| US features of gout at knees | Double contour sign for withdrawal arm | At 6 months |
| US features of gout at knees | Double contour sign for withdrawal arm | At 12 months |
| US features of gout at knees | Double contour sign for withdrawal arm | At 18 months |
| US features of gout at knees | Double contour sign for both arms | At 24 months |
| US features of gout at knees | Double contour sign for withdrawal arm | At 30 months |
| US features of gout at knees | Double contour sign for withdrawal arm | At 36 months |
| Urate levels | At 6 months |
| Urate levels | At 12 months |
| Urate levels | At 18 months |
| Urate levels | At 24 months |
| Urate levels | At 30 months |
| Urate levels | At 36 months |
| Change from baseline of patient's global assessment of disease activity | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies 0-5-point Likert scale, the higher the score the more severe the disease | At 12 months |
| Change from baseline of patient's global assessment of disease activity | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies 0-5-point Likert scale, the higher the score the more severe the disease | At 24 months |
| Change from baseline of patient's global assessment of disease activity | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies 0-5-point Likert scale, the higher the score the more severe the disease | At 36 months |
| Change from baseline in Healthrelated quality of life | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies EuroQol 5-domain-3L (EQ-5D3L) questionnaire The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems | At 12 months |
| Change from baseline in Healthrelated quality of life | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies EuroQol 5-domain-3L (EQ-5D3L) questionnaire The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems | At 24 months |
| Change from baseline in Healthrelated quality of life | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies EuroQol 5-domain-3L (EQ-5D3L) questionnaire The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems | At 36 months |
| Change from baseline in Activity limitation | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies Health Assessment Questionnaire II is a 10-item score. Each item is rated on a 4-point Likert scale HAQ-II mean score ranges from 0 (no disability) to 3 (severe disability) | At 12 months |
| Change from baseline in Activity limitation | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies Health Assessment Questionnaire II is a 10-item score. Each item is rated on a 4-point Likert scale HAQ-II mean score ranges from 0 (no disability) to 3 (severe disability) | At 24 months |
| Change from baseline in Activity limitation | Outcome Measures in Rheumatology (OMERACT) core outcome domains for long-term gout studies Health Assessment Questionnaire II is a 10-item score. Each item is rated on a 4-point Likert scale HAQ-II mean score ranges from 0 (no disability) to 3 (severe disability) | At 36 months |
| Incidence of Major CardioVascular events | Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death | At 6 months |
| Incidence of Major CardioVascular events | Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death | At 12 months |
| Incidence of Major CardioVascular events | Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death | At 18 months |
| Incidence of Major CardioVascular events | Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death | At 24 months |
| Incidence of Major CardioVascular events | Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death | At 30 months |
| Incidence of Major CardioVascular events | Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death | At 36 months |
| estimated glomerular filtration rate (eGFR) | Renal function | At 6 months |
| estimated glomerular filtration rate (eGFR) | Renal function | At 12 months |
| estimated glomerular filtration rate (eGFR) | Renal function | At 18 months |
| estimated glomerular filtration rate (eGFR) | Renal function | At 24 months |
| estimated glomerular filtration rate (eGFR) | Renal function | At 30 months |
| estimated glomerular filtration rate (eGFR) | Renal function | At 36 months |
| Incidence of comorbidities | Charlson index Total score varies from 0 to >=5 The lower the score the higher the estimated 10-year survival | At 12 months |
| Incidence of comorbidities | Charlson index Total score varies from 0 to >=5 The lower the score the higher the estimated 10-year survival | At 24 months |
| Incidence of comorbidities | Charlson index Total score varies from 0 to >=5 The lower the score the higher the estimated 10-year survival | At 36 months |
| Overall Survival | At 12 months |
| Overall Survival | At 24 months |
| Overall Survival | At 36 months |
| Consumption of other drugs | Colchicine, NSAIDs, steroids using a patient self-reported notebook | At 6 months |
| Consumption of other drugs | Colchicine, NSAIDs, steroids using a patient self-reported notebook | At 12 months |
| Consumption of other drugs | Colchicine, NSAIDs, steroids using a patient self-reported notebook | At 18 months |
| Consumption of other drugs | Colchicine, NSAIDs, steroids using a patient self-reported notebook | At 24 months |
| Consumption of other drugs | Colchicine, NSAIDs, steroids using a patient self-reported notebook | At 30 months |
| Consumption of other drugs | Colchicine, NSAIDs, steroids using a patient self-reported notebook | At 36 months |
| Incidence of adverse events and serious adverse events | According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events) | At 6 months |
| Incidence of adverse events and serious adverse events | According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events) | At 12 months |
| Incidence of adverse events and serious adverse events | According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events) | At 18 months |
| Incidence of adverse events and serious adverse events | According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events) | At 24 months |
| Incidence of adverse events and serious adverse events | According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events) | At 30 months |
| Incidence of adverse events and serious adverse events | According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events) | At 36 months |
| Adherence to ULT | Assessed by a questionnaire | At 6 months |
| Adherence to ULT | Assessed by a questionnaire | At 12 months |
| Adherence to ULT | Assessed by a questionnaire | At 18 months |
| Adherence to ULT | Assessed by a questionnaire | At 24 months |
| Adherence to ULT | Assessed by a questionnaire | At 30 months |
| Adherence to ULT | Assessed by a questionnaire | At 36 months |
| Incremental Cost effectiveness ratios estimating cost per QALY gained | Up to 36 months |
| Incremental Cost effectiveness ratios estimating cost per flare avoided. | Up to 36 months |