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Gout ChronicPhase 2STINGNCT06956885

Maintenance or Withdrawal of Urate Lowering Therapy According to Ultrasound Features in Gout Patients: a Randomised Controlled Trial Stop Treatment In Gout

A Phase 2 study testing Discontibuation of oral ULT and Maintenance of ULT in people with Gout Chronic, run by Assistance Publique - Hôpitaux de Paris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

According to international recommendations, urate lowering therapy (ULT), mainly the xanthine oxidase inhibitors (XOIs) allopurinol and febuxostat, should be prescribed lifelong in gout patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout Chronic
What is being tested?
Discontibuation of oral ULT and Maintenance of ULT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
No sites listed yet
Study dates
1 May 2025to 1 May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Gout, defined according to the 2015 ACR/EULAR classification criteria
  • No flares for at least 2 years
  • No tophi
  • Currently receiving allopurinol or febuxostat taken for at least 2 years and SUA levels ≤ 60 mg/l
  • No urate deposit on ultrasound at inclusion visit at both MTPs 1 and knees
Show all 9Show fewer
  • Ability to provide informed consent
  • Women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain during treatment highly effective contraception (ie,abstinence, combined estrogen- and progestogen-containing hormonal contraception, ovulation inhibitors (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner).
  • Health Insurance

Who cannot join

  • Unstable systemic medical condition (e.g., New York Heart Association stage IV heart failure, recent myocardial infarction, advanced cancer)
  • History of allergy to allopurinol or febuxostat or one of the excipients
  • Association with azathioprine, mercaptopurine (cytostatics-antimetabolites)
  • Contraindications to experimental medicinal products or auxiliary medicinal products
  • CKD stage 4 (eGFR less than 30 ml/mn/1.73 m2)
  • Ongoing treatment with uricosurics (benzbromarone and probenecid) or uricase
Show all 9Show fewer
  • Patient on SMA (state medical aid-AME)
  • Participation in other clinical trial on medicinal product for human use
  • Lack of contraception for women of childbearing potential.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Paul Richette, MD PhD contact

1 49 95 86 31 ext. +33

pierre.moine@aphp.fr

Jérôme Lambert, MD PhD contact

1 42 49 49 60 ext. +33

jerome.lambert@u-paris.fr

About this study

Official title: Maintenance or Withdrawal of Urate Lowering Therapy According to Ultrasound Features in Gout Patients: a Randomised Controlled Trial

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.

Conditions
Gout Chronic
Being tested
Discontibuation of oral ULT, Maintenance of ULT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Discontibuation of oral ULTDrug

    Patients will stop the ULT at D0. They will have an US scan to look for urate deposits at each visit.

  • Maintenance of ULTDrug

    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.

Study groups in NCT06956885
Study groupRoleWhat they receive
Discontinuation of urate lowering therapyExperimentalNot described
Receives: Drug: Discontibuation of oral ULT
Continuation of urate lowering therapy (usual care)Active comparatorNot described
Receives: Drug: Maintenance of ULT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients experiencing one or more flares

    According to the Gaffo's criteria

    Measured: At 2 years

Secondary outcomes (76)

  1. Proportion of patients experiencing one or more flares

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 6 months

  2. Proportion of patients experiencing one or more flares

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 12 months

  3. Proportion of patients experiencing one or more flares

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 18 months

  4. Proportion of patients experiencing one or more flares

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 30 months

  5. Proportion of patients experiencing one or more flares

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 36 months

  6. Mean flare rates

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 6 months

  7. Mean flare rates

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 12 months

  8. Mean flare rates

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 18 months

  9. Mean flare rates

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 24 months

  10. Mean flare rates

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 30 months

  11. Mean flare rates

    According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

    Measured: At 36 months

  12. US features of gout at MPT1s

    Double contour sign, tophi, aggregates for withdrawal arm

    Measured: At 6 months

  13. US features of gout at MPT1s

    Double contour sign, tophi, aggregates for withdrawal arm

    Measured: At 12 months

  14. US features of gout at MPT1s

    Double contour sign, tophi, aggregates for withdrawal arm

    Measured: At 18 months

  15. US features of gout at MPT1s

    Double contour sign, tophi, aggregates for both arms

    Measured: At 24 months

  16. US features of gout at MPT1s

    Double contour sign, tophi, aggregates for withdrawal arm

    Measured: At 30 months

  17. US features of gout at MPT1s

    Double contour sign, tophi, aggregates for withdrawal arm

    Measured: At 36 months

  18. US features of gout at knees

    Double contour sign for withdrawal arm

    Measured: At 6 months

  19. US features of gout at knees

    Double contour sign for withdrawal arm

    Measured: At 12 months

  20. US features of gout at knees

    Double contour sign for withdrawal arm

    Measured: At 18 months

  21. US features of gout at knees

    Double contour sign for both arms

    Measured: At 24 months

  22. US features of gout at knees

    Double contour sign for withdrawal arm

    Measured: At 30 months

  23. US features of gout at knees

    Double contour sign for withdrawal arm

    Measured: At 36 months

  24. Urate levels

    Measured: At 6 months

  25. Urate levels

    Measured: At 12 months

  26. Urate levels

    Measured: At 18 months

  27. Urate levels

    Measured: At 24 months

  28. Urate levels

    Measured: At 30 months

  29. Urate levels

    Measured: At 36 months

  30. 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

    Measured: At 12 months

  31. 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

    Measured: At 24 months

  32. 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

    Measured: At 36 months

  33. 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

    Measured: At 12 months

  34. 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

    Measured: At 24 months

  35. 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

    Measured: At 36 months

  36. 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)

    Measured: At 12 months

  37. 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)

    Measured: At 24 months

  38. 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)

    Measured: At 36 months

  39. Incidence of Major CardioVascular events

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

    Measured: At 6 months

  40. Incidence of Major CardioVascular events

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

    Measured: At 12 months

  41. Incidence of Major CardioVascular events

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

    Measured: At 18 months

  42. Incidence of Major CardioVascular events

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

    Measured: At 24 months

  43. Incidence of Major CardioVascular events

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

    Measured: At 30 months

  44. Incidence of Major CardioVascular events

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

    Measured: At 36 months

  45. estimated glomerular filtration rate (eGFR)

    Renal function

    Measured: At 6 months

  46. estimated glomerular filtration rate (eGFR)

    Renal function

    Measured: At 12 months

  47. estimated glomerular filtration rate (eGFR)

    Renal function

    Measured: At 18 months

  48. estimated glomerular filtration rate (eGFR)

    Renal function

    Measured: At 24 months

  49. estimated glomerular filtration rate (eGFR)

    Renal function

    Measured: At 30 months

  50. estimated glomerular filtration rate (eGFR)

    Renal function

    Measured: At 36 months

  51. Incidence of comorbidities

    Charlson index Total score varies from 0 to >=5 The lower the score the higher the estimated 10-year survival

    Measured: At 12 months

  52. Incidence of comorbidities

    Charlson index Total score varies from 0 to >=5 The lower the score the higher the estimated 10-year survival

    Measured: At 24 months

  53. Incidence of comorbidities

    Charlson index Total score varies from 0 to >=5 The lower the score the higher the estimated 10-year survival

    Measured: At 36 months

  54. Overall Survival

    Measured: At 12 months

  55. Overall Survival

    Measured: At 24 months

  56. Overall Survival

    Measured: At 36 months

  57. Consumption of other drugs

    Colchicine, NSAIDs, steroids using a patient self-reported notebook

    Measured: At 6 months

  58. Consumption of other drugs

    Colchicine, NSAIDs, steroids using a patient self-reported notebook

    Measured: At 12 months

  59. Consumption of other drugs

    Colchicine, NSAIDs, steroids using a patient self-reported notebook

    Measured: At 18 months

  60. Consumption of other drugs

    Colchicine, NSAIDs, steroids using a patient self-reported notebook

    Measured: At 24 months

  61. Consumption of other drugs

    Colchicine, NSAIDs, steroids using a patient self-reported notebook

    Measured: At 30 months

  62. Consumption of other drugs

    Colchicine, NSAIDs, steroids using a patient self-reported notebook

    Measured: At 36 months

  63. Incidence of adverse events and serious adverse events

    According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)

    Measured: At 6 months

  64. Incidence of adverse events and serious adverse events

    According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)

    Measured: At 12 months

  65. Incidence of adverse events and serious adverse events

    According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)

    Measured: At 18 months

  66. Incidence of adverse events and serious adverse events

    According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)

    Measured: At 24 months

  67. Incidence of adverse events and serious adverse events

    According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)

    Measured: At 30 months

  68. Incidence of adverse events and serious adverse events

    According to CTCAE v5.0 classification (Common Terminology Criteria for Adverse Events)

    Measured: At 36 months

  69. Adherence to ULT

    Assessed by a questionnaire

    Measured: At 6 months

  70. Adherence to ULT

    Assessed by a questionnaire

    Measured: At 12 months

  71. Adherence to ULT

    Assessed by a questionnaire

    Measured: At 18 months

  72. Adherence to ULT

    Assessed by a questionnaire

    Measured: At 24 months

  73. Adherence to ULT

    Assessed by a questionnaire

    Measured: At 30 months

  74. Adherence to ULT

    Assessed by a questionnaire

    Measured: At 36 months

  75. Incremental Cost effectiveness ratios estimating cost per QALY gained

    Measured: Up to 36 months

  76. Incremental Cost effectiveness ratios estimating cost per flare avoided.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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 -.
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956885
Sponsor's protocol ID
APHP230854
Acronym
STING
Status last verified
Apr 2025
First submitted
25 Apr 2025
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Discontibuation of oral ULT and Maintenance of ULT in people with Gout Chronic, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul Richette, MD PhD (1 49 95 86 31 ext. +33, pierre.moine@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients experiencing one or more flares (time frame: At 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06956885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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