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

NCT ID: NCT06956885

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2030-05-01

Brief 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.

Conditions

Gout Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Discontinuation of urate lowering therapy

Group Type: EXPERIMENTAL

Discontibuation of oral ULT

Intervention Type: DRUG

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

Continuation of urate lowering therapy (usual care)

Group Type: ACTIVE_COMPARATOR

Maintenance of ULT

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Paul Richette, MD PhD

Role: CONTACT

pierre.moine@aphp.fr

1 49 95 86 31 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

1 42 49 49 60 ext. +33

Other Identifiers

APHP230854

Identifier Type: -

Identifier Source: org_study_id