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NCT Number: NCT06956885

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

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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Key information

Conditions

Gout Chronic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Proportion of patients experiencing one or more flares

    Time frame: At 2 years

    According to the Gaffo's criteria

Secondary outcomes

  1. Proportion of patients experiencing one or more flares

    Time frame: At 6 months

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

  2. Proportion of patients experiencing one or more flares

    Time frame: At 12 months

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

  3. Proportion of patients experiencing one or more flares

    Time frame: At 18 months

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

  4. Proportion of patients experiencing one or more flares

    Time frame: At 30 months

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

  5. Proportion of patients experiencing one or more flares

    Time frame: At 36 months

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

  6. Mean flare rates

    Time frame: At 6 months

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

  7. Mean flare rates

    Time frame: At 12 months

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

  8. Mean flare rates

    Time frame: At 18 months

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

  9. Mean flare rates

    Time frame: At 24 months

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

  10. Mean flare rates

    Time frame: At 30 months

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

  11. Mean flare rates

    Time frame: At 36 months

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

  12. US features of gout at MPT1s

    Time frame: At 6 months

    Double contour sign, tophi, aggregates for withdrawal arm

  13. US features of gout at MPT1s

    Time frame: At 12 months

    Double contour sign, tophi, aggregates for withdrawal arm

  14. US features of gout at MPT1s

    Time frame: At 18 months

    Double contour sign, tophi, aggregates for withdrawal arm

  15. US features of gout at MPT1s

    Time frame: At 24 months

    Double contour sign, tophi, aggregates for both arms

  16. US features of gout at MPT1s

    Time frame: At 30 months

    Double contour sign, tophi, aggregates for withdrawal arm

  17. US features of gout at MPT1s

    Time frame: At 36 months

    Double contour sign, tophi, aggregates for withdrawal arm

  18. US features of gout at knees

    Time frame: At 6 months

    Double contour sign for withdrawal arm

  19. US features of gout at knees

    Time frame: At 12 months

    Double contour sign for withdrawal arm

  20. US features of gout at knees

    Time frame: At 18 months

    Double contour sign for withdrawal arm

  21. US features of gout at knees

    Time frame: At 24 months

    Double contour sign for both arms

  22. US features of gout at knees

    Time frame: At 30 months

    Double contour sign for withdrawal arm

  23. US features of gout at knees

    Time frame: At 36 months

    Double contour sign for withdrawal arm

  24. Urate levels

    Time frame: At 6 months

  25. Urate levels

    Time frame: At 12 months

  26. Urate levels

    Time frame: At 18 months

  27. Urate levels

    Time frame: At 24 months

  28. Urate levels

    Time frame: At 30 months

  29. Urate levels

    Time frame: At 36 months

  30. Change from baseline of patient's global assessment of disease activity

    Time frame: At 12 months

    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

  31. Change from baseline of patient's global assessment of disease activity

    Time frame: At 24 months

    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

  32. Change from baseline of patient's global assessment of disease activity

    Time frame: At 36 months

    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

  33. Change from baseline in Healthrelated quality of life

    Time frame: At 12 months

    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

  34. Change from baseline in Healthrelated quality of life

    Time frame: At 24 months

    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

  35. Change from baseline in Healthrelated quality of life

    Time frame: At 36 months

    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

  36. Change from baseline in Activity limitation

    Time frame: At 12 months

    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)

  37. Change from baseline in Activity limitation

    Time frame: At 24 months

    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)

  38. Change from baseline in Activity limitation

    Time frame: At 36 months

    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)

  39. Incidence of Major CardioVascular events

    Time frame: At 6 months

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

  40. Incidence of Major CardioVascular events

    Time frame: At 12 months

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

  41. Incidence of Major CardioVascular events

    Time frame: At 18 months

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

  42. Incidence of Major CardioVascular events

    Time frame: At 24 months

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

  43. Incidence of Major CardioVascular events

    Time frame: At 30 months

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

  44. Incidence of Major CardioVascular events

    Time frame: At 36 months

    Including nonfatal stroke, nonfatal myocardial infarction, cardiovascular death

  45. estimated glomerular filtration rate (eGFR)

    Time frame: At 6 months

    Renal function

  46. estimated glomerular filtration rate (eGFR)

    Time frame: At 12 months

    Renal function

  47. estimated glomerular filtration rate (eGFR)

    Time frame: At 18 months

    Renal function

  48. estimated glomerular filtration rate (eGFR)

    Time frame: At 24 months

    Renal function

  49. estimated glomerular filtration rate (eGFR)

    Time frame: At 30 months

    Renal function

  50. estimated glomerular filtration rate (eGFR)

    Time frame: At 36 months

    Renal function

  51. Incidence of comorbidities

    Time frame: At 12 months

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

  52. Incidence of comorbidities

    Time frame: At 24 months

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

  53. Incidence of comorbidities

    Time frame: At 36 months

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

  54. Overall Survival

    Time frame: At 12 months

  55. Overall Survival

    Time frame: At 24 months

  56. Overall Survival

    Time frame: At 36 months

  57. Consumption of other drugs

    Time frame: At 6 months

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

  58. Consumption of other drugs

    Time frame: At 12 months

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

  59. Consumption of other drugs

    Time frame: At 18 months

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

  60. Consumption of other drugs

    Time frame: At 24 months

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

  61. Consumption of other drugs

    Time frame: At 30 months

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

  62. Consumption of other drugs

    Time frame: At 36 months

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

  63. Incidence of adverse events and serious adverse events

    Time frame: At 6 months

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

  64. Incidence of adverse events and serious adverse events

    Time frame: At 12 months

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

  65. Incidence of adverse events and serious adverse events

    Time frame: At 18 months

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

  66. Incidence of adverse events and serious adverse events

    Time frame: At 24 months

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

  67. Incidence of adverse events and serious adverse events

    Time frame: At 30 months

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

  68. Incidence of adverse events and serious adverse events

    Time frame: At 36 months

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

  69. Adherence to ULT

    Time frame: At 6 months

    Assessed by a questionnaire

  70. Adherence to ULT

    Time frame: At 12 months

    Assessed by a questionnaire

  71. Adherence to ULT

    Time frame: At 18 months

    Assessed by a questionnaire

  72. Adherence to ULT

    Time frame: At 24 months

    Assessed by a questionnaire

  73. Adherence to ULT

    Time frame: At 30 months

    Assessed by a questionnaire

  74. Adherence to ULT

    Time frame: At 36 months

    Assessed by a questionnaire

  75. Incremental Cost effectiveness ratios estimating cost per QALY gained

    Time frame: Up to 36 months

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

    Time frame: Up to 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, MD PhD

CONTACT

[email protected]

1 42 49 49 60 ext. +33

Paul Richette, MD PhD

CONTACT

[email protected]

1 49 95 86 31 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: STING

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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