Status:
NOT_YET_RECRUITING
Maintenance or Withdrawal of Urate Lowering Therapy According to Ultrasound Features in Gout Patients: a Randomised Controlled Trial Stop Treatment In Gout
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gout Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Howe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06956885
Start Date
May 1 2025
End Date
May 1 2030
Last Update
May 4 2025
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