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

ConditionGout Chronic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Gout, defined according to the 2015 ACR/EULAR classification criteria

No flares for at least 2 years

No tophi

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Discontinuation of urate lowering therapyExperimental treatment 1 intervention
Group B: Continuation of urate lowering therapy (usual care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients experiencing one or more flares

According to the Gaffo's criteria

Time frame
At 2 years

Secondary outcomes

1

Proportion of patients experiencing one or more flares

According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

Time frame
At 6 months
2

Proportion of patients experiencing one or more flares

According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

Time frame
At 12 months
3

Proportion of patients experiencing one or more flares

According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

Time frame
At 18 months
4

Proportion of patients experiencing one or more flares

According to both the Gaffo's criteria and the patient-reported Gout Attack Intensity Score (GAIS)

Time frame
At 30 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: