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

Assistance Publique - Hôpitaux de Paris

Status and phase

Not yet enrolling

Phase 2

Conditions

Gout Chronic

Treatments

Drug: Maintenance of ULT

Drug: Discontibuation of oral ULT

Study type

Interventional

Funder types

Other

Identifiers

NCT06956885

APHP230854

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.