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

NCT06956885 | Not Yet Recruiting Phase 2

• 1 other identifier: APHP230854
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing one or more flares

  According to the Gaffo's criteria

  At 2 years

Secondary Outcomes (76)

• Proportion of patients experiencing one or more flares

  At 6 months

• Proportion of patients experiencing one or more flares

  At 12 months

• Proportion of patients experiencing one or more flares

  At 18 months

• Proportion of patients experiencing one or more flares

  At 30 months

• Proportion of patients experiencing one or more flares

  At 36 months

Study Arms (2)

Discontinuation of urate lowering therapy

EXPERIMENTAL

Drug: Discontibuation of oral ULT

Continuation of urate lowering therapy (usual care)

ACTIVE COMPARATOR

Drug: Maintenance of ULT

Interventions

Discontibuation of oral ULT DRUG

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

Discontinuation of urate lowering therapy

Maintenance of ULT 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.

Continuation of urate lowering therapy (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Central Study Contacts

Paul Richette, MD PhD

CONTACT

1 49 95 86 31; pierre.moine@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

1 42 49 49 60; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, parallel arm, non-blinded randomised controlled non-inferiority clinical trial. Gout patients in remission and no urate deposits as assessed by US will be randomised to i) a maintenance group -ULT will be pursued - or ii) a withdrawal experimental group - discontinuation of ULT -.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 4, 2025

Record last verified: 2025-04