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Study on Stopping Allopurinol or Febuxostat in Gout Patients in Remission

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying gout, a type of arthritis that causes sudden and severe pain, redness, and swelling in the joints. The study will explore the effects of two medications, allopurinol and febuxostat, which are commonly used to lower uric acid levels in the body and help manage gout symptoms. These medications are taken orally in the form of tablets.

The purpose of the study is to determine whether stopping the use of these medications in patients whose gout is in remission, as monitored by ultrasound scans, is as effective as continuing the treatment in preventing future gout flares over a period of two years. Participants in the study will either continue their current medication or stop taking it, and their health will be monitored through regular check-ups and ultrasound scans to observe any changes in their condition.

The study will last for several years, with participants being observed at different intervals to track the occurrence of gout flares and other health indicators. The goal is to understand the long-term effects of maintaining or withdrawing urate-lowering therapy in patients with gout and to assess the impact on their overall health and quality of life. This research aims to provide valuable insights into the management of gout and help improve treatment strategies for patients in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, gout diagnosis, and current treatment with allopurinol or febuxostat for at least two years.

    No gout flares should have occurred for at least two years, and no urate deposits should be visible on ultrasound at the initial visit.

  2. Step 2

    Randomization

    Participants are randomly assigned to either continue their current urate-lowering therapy (ULT) or to withdraw from it.

    The objective is to compare the risk of gout flares between those who continue and those who stop the therapy.

  3. Step 3

    Treatment phase

    For those continuing treatment, allopurinol or febuxostat is taken orally as prescribed.

    The dosage and frequency are determined by the healthcare provider based on individual needs.

  4. Step 4

    Monitoring and assessments

    Regular assessments occur at months 6, 12, 18, 24, 30, and 36 to monitor for gout flares and other health indicators.

    Ultrasound scans are used to check for urate deposits, and blood tests may be conducted to measure urate levels.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the proportion of participants experiencing gout flares at two years.

    Secondary outcomes include flare rates at various intervals, changes in health-related quality of life, and renal function.

  6. Step 6

    Completion of the study

    The study is expected to conclude by February 2029.

    Final assessments will determine the long-term effects of continuing versus withdrawing from ULT.

Who can join the trial?

8 criteria

  • Must be **18 years or older**.
  • Must have **gout**, which is a type of arthritis, diagnosed according to specific guidelines from 2015.
  • Must not have had any **gout flares** (sudden attacks of pain and swelling) for at least **2 years**.
  • Must not have **tophi**, which are lumps formed by uric acid crystals under the skin.
  • Must currently be taking **allopurinol** or **febuxostat** (medications to lower uric acid) for at least **2 years**, with **serum uric acid (SUA)** levels at or below **60 mg/l**.
  • Must not have any **urate deposits** (build-up of uric acid crystals) visible on an **ultrasound** scan at the first visit, specifically at the big toe joints (MTPs 1) and knees.
  • Must be able to **provide informed consent**, meaning you understand the study and agree to participate.
  • Must have **health insurance**.

Who cannot join the trial?

4 criteria

  • Patients who are not adults cannot participate. This means only adults can join the study.
  • Patients who do not have **gout** cannot participate. Gout is a type of arthritis that causes pain and swelling in the joints.
  • Patients who are not in **remission** cannot participate. Remission means that the symptoms of gout are not currently active or causing problems.
  • Patients who are part of a **vulnerable population** cannot participate. Vulnerable populations include groups of people who might need special protection or care.
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Investigated drugs

Urate Lowering Therapy (ULT) is a treatment used to reduce the levels of uric acid in the blood. This is important for patients with gout, as high levels of uric acid can lead to the formation of crystals in the joints, causing pain and inflammation. The therapy aims to prevent gout flares and manage symptoms by maintaining lower uric acid levels. In this trial, the role of ULT is to determine whether continuing or stopping the therapy affects the risk of gout flares in patients who are in remission.

What is already known about the treatment

Urate Lowering Therapy (ULT) – This medication is administered orally and is used to manage gout in adult patients. It is currently being studied in clinical trials to assess its effectiveness in maintaining remission or preventing flares when withdrawn, as monitored by ultrasound scans. The main therapeutic indication for ULT is to lower uric acid levels in the blood, thereby reducing the risk of gout attacks. At the molecular level, ULT works by inhibiting the enzyme responsible for uric acid production or by increasing its excretion. It is classified pharmacologically as an antihyperuricemic agent.

Investigated diseases

Gout – Gout is a type of arthritis characterized by sudden, severe attacks of pain, swelling, redness, and tenderness in the joints, often the joint at the base of the big toe. It occurs when urate crystals accumulate in the joint, causing inflammation and intense pain. These crystals can form when there are high levels of uric acid in the blood. The body produces uric acid when it breaks down purines, substances that are found naturally in the body and in certain foods. Gout attacks can occur suddenly, often waking you up in the middle of the night with the sensation that your big toe is on fire. The affected joint is hot, swollen, and so tender that even the weight of the sheet on it may seem intolerable.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515714-40-00Protocol codeAPHP230854Estimated enrolment450 patientsSponsorAssistance Publique Hopitaux De Paris

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