A Phase 2 interventional study of Discontibuation of oral ULT and Maintenance of ULT in Gout Chronic, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 450 is above the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Discontibuation of oral ULT
Drug: Maintenance of ULT
Patients will stop the ULT at D0. They will have an US scan to look for urate deposits at each visit.
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.
Proportion of patients experiencing one or more flares
According to the Gaffo's criteria
Time frame: At 2 years
Proportion of patients experiencing one or more flares
According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)
Time frame: At 6 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At 36 months
Mean flare rates
According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)
Time frame: At 6 months
Mean flare rates
According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)
Time frame: At 12 months
Mean flare rates
According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)
Time frame: At 18 months
Mean flare rates
According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)
Time frame: At 24 months
Mean flare rates
According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)
Time frame: At 30 months
Mean flare rates
According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)
Time frame: At 36 months
US features of gout at MPT1s
Double contour sign, tophi, aggregates for withdrawal arm
Time frame: At 6 months
US features of gout at MPT1s
Double contour sign, tophi, aggregates for withdrawal arm
Time frame: At 12 months
US features of gout at MPT1s
Double contour sign, tophi, aggregates for withdrawal arm
Time frame: At 18 months
US features of gout at MPT1s
Double contour sign, tophi, aggregates for both arms
Time frame: At 24 months
US features of gout at MPT1s
Double contour sign, tophi, aggregates for withdrawal arm
Time frame: At 30 months
US features of gout at MPT1s
Double contour sign, tophi, aggregates for withdrawal arm
Time frame: At 36 months
US features of gout at knees
Double contour sign for withdrawal arm
Time frame: At 6 months
US features of gout at knees
Double contour sign for withdrawal arm
Time frame: At 12 months
US features of gout at knees
Double contour sign for withdrawal arm
Time frame: At 18 months
US features of gout at knees
Double contour sign for both arms
Time frame: At 24 months
US features of gout at knees
Double contour sign for withdrawal arm
Time frame: At 30 months
US features of gout at knees
Double contour sign for withdrawal arm
Time frame: At 36 months
Urate levels
Time frame: At 6 months
Urate levels
Time frame: At 12 months
Urate levels
Time frame: At 18 months
Urate levels
Time frame: At 24 months
Urate levels
Time frame: At 30 months
Urate levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At 36 months
Incidence of Major CardioVascular events
Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death
Time frame: At 6 months
Incidence of Major CardioVascular events
Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death
Time frame: At 12 months
Incidence of Major CardioVascular events
Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death
Time frame: At 18 months
Incidence of Major CardioVascular events
Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death
Time frame: At 24 months
Incidence of Major CardioVascular events
Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death
Time frame: At 30 months
Incidence of Major CardioVascular events
Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death
Time frame: At 36 months
estimated glomerular filtration rate (eGFR)
Renal function
Time frame: At 6 months
estimated glomerular filtration rate (eGFR)
Renal function
Time frame: At 12 months
estimated glomerular filtration rate (eGFR)
Renal function
Time frame: At 18 months
estimated glomerular filtration rate (eGFR)
Renal function
Time frame: At 24 months
estimated glomerular filtration rate (eGFR)
Renal function
Time frame: At 30 months
estimated glomerular filtration rate (eGFR)
Renal function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 36 months
Overall Survival
Time frame: At 12 months
Overall Survival
Time frame: At 24 months
Overall Survival
Time frame: At 36 months
Consumption of other drugs
Colchicine, NSAIDs, steroids using a patient self-reported notebook
Time frame: At 6 months
Consumption of other drugs
Colchicine, NSAIDs, steroids using a patient self-reported notebook
Time frame: At 12 months
Consumption of other drugs
Colchicine, NSAIDs, steroids using a patient self-reported notebook
Time frame: At 18 months
Consumption of other drugs
Colchicine, NSAIDs, steroids using a patient self-reported notebook
Time frame: At 24 months
Consumption of other drugs
Colchicine, NSAIDs, steroids using a patient self-reported notebook
Time frame: At 30 months
Consumption of other drugs
Colchicine, NSAIDs, steroids using a patient self-reported notebook
Time frame: At 36 months
Incidence of adverse events and serious adverse events
According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)
Time frame: At 6 months
Incidence of adverse events and serious adverse events
According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)
Time frame: At 12 months
Incidence of adverse events and serious adverse events
According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)
Time frame: At 18 months
Incidence of adverse events and serious adverse events
According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)
Time frame: At 24 months
Incidence of adverse events and serious adverse events
According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)
Time frame: At 30 months
Incidence of adverse events and serious adverse events
According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)
Time frame: At 36 months
Adherence to ULT
Assessed by a questionnaire
Time frame: At 6 months
Adherence to ULT
Assessed by a questionnaire
Time frame: At 12 months
Adherence to ULT
Assessed by a questionnaire
Time frame: At 18 months
Adherence to ULT
Assessed by a questionnaire
Time frame: At 24 months
Adherence to ULT
Assessed by a questionnaire
Time frame: At 30 months
Adherence to ULT
Assessed by a questionnaire
Time frame: At 36 months
Incremental Cost effectiveness ratios estimating cost per QALY gained
Time frame: Up to 36 months
Incremental Cost effectiveness ratios estimating cost per flare avoided.
Time frame: Up to 36 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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