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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Stop Treatment In Gout," is investigating whether patients with gout can safely stop taking their urate-lowering therapy (ULT) medications, such as allopurinol and febuxostat, if certain conditions are met. The researchers believe that if a patient's uric acid levels are well-managed and ultrasounds show no signs of urate deposits in the joints, the risk of experiencing painful gout flares after stopping the medication may be very low. This is important because many patients struggle with sticking to their treatment plans due to side effects or the need for regular check-ups.

To be eligible for the trial, participants must be at least 18 years old, have a diagnosis of gout, and have been free of flare-ups for at least two years. They should have been taking ULT for a minimum of two years and have normal uric acid levels without any visible deposits on ultrasound. Participants will be monitored closely during the study, and women who can become pregnant will need to use effective birth control throughout the trial. This study aims to provide valuable information on whether it is safe for certain patients to stop their treatment, potentially leading to improved quality of life for gout sufferers.

Gender

ALL

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.