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NOT YET RECRUITING
NCT06956885
PHASE2

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2025-05-01

Completion Date

2030-05-01

Last Updated

2025-05-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Discontibuation of oral ULT

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

DRUG

Maintenance of ULT

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.