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Not yet recruiting NCT06956885

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

Phase II Interventional Gout Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Discontibuation of oral ULT, Maintenance of ULT.
Who it may be relevant to
Registry conditions: Gout Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Primary outcome measures

  • Proportion of patients experiencing one or more flares [Time frame: At 2 years]
Secondary outcome measures (12)
  • Proportion of patients experiencing one or more flares [Time frame: At 6 months]
  • Proportion of patients experiencing one or more flares [Time frame: At 12 months]
  • Proportion of patients experiencing one or more flares [Time frame: At 18 months]
  • Proportion of patients experiencing one or more flares [Time frame: At 30 months]
  • Proportion of patients experiencing one or more flares [Time frame: At 36 months]
  • Mean flare rates [Time frame: At 6 months]
  • Mean flare rates [Time frame: At 12 months]
  • Mean flare rates [Time frame: At 18 months]
  • Mean flare rates [Time frame: At 24 months]
  • Mean flare rates [Time frame: At 30 months]
  • Mean flare rates [Time frame: At 36 months]
  • US features of gout at MPT1s [Time frame: At 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06956885 · APHP230854

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗