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

Phase 2Not Yet RecruitingNCT06956885

Assistance Publique - Hôpitaux de Paris450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Gout Chronic

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of patients experiencing one or more flares

According to the Gaffo's criteria

Time frame: At 2 years