Study on Gout Treatment: Comparing Allopurinol, Benzbromarone, and Febuxostat in Patients with Gout in Remission

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What is this study about?

This clinical trial is focused on studying gout, a condition characterized by painful joint inflammation due to the accumulation of uric acid crystals. The study will explore the effects of three different medications used to lower uric acid levels: allopurinol, benzbromarone, and febuxostat. These medications are taken orally and are commonly used to manage gout by reducing uric acid in the body.

The purpose of the study is to compare two strategies: continuing urate-lowering therapy versus stopping it in patients whose gout is in remission. Remission means that the patient has not experienced any gout flares, visible uric acid deposits called tophi, or significant pain due to gout for at least 12 months. The study will last for 24 months, during which participants will be monitored to see if they continue to meet the criteria for remission.

Participants will be randomly assigned to either continue their current urate-lowering medication or to stop taking it. The study will assess how many participants in each group remain in remission during the last six months of the study. This will help determine the best strategy for managing gout in remission. Additionally, the study will evaluate the cost-effectiveness of these strategies, which means it will look at the balance between the benefits of the treatment and its costs.

1 joining the study

Upon joining the study, the patient must have a clinical diagnosis of gout and meet specific criteria, including being in remission for at least 12 months. This means no gout flares, no visible tophi, and maintaining a serum urate level of 0.36 mmol/l or lower.

The patient must be 18 years or older, mentally competent, and have provided written informed consent.

2 treatment phase

The patient will continue or cease the use of urate lowering therapies (ULT) such as allopurinol, benzbromarone, and febuxostat. These medications are taken orally.

The specific dosage and frequency of these medications will be determined by the study protocol and the patient’s current treatment plan.

3 follow-up period

The follow-up period lasts for 24 months. During the last six months, the patient’s condition will be assessed to determine if they meet the adapted preliminary gout remission criteria.

The criteria include no tophi, no flares, pain due to gout less than 2 on a 10-point scale, and disease activity less than 2, independent of serum urate level.

4 assessment of outcomes

The primary outcome is the difference between groups in the proportion of patients meeting the remission criteria during the last six months of the follow-up period.

If the superiority of one strategy over the other is not demonstrated, a secondary analysis will be conducted to explore non-inferiority.

Who Can Join the Study?

Patients must have a clinical diagnosis of gout or meet the 2015 ACR-EULAR gout criteria. Gout is a type of arthritis that causes sudden, severe pain, swelling, and redness in the joints.
Patients should be using ULT (allopurinol, benzbromarone, and/or febuxostat). ULT stands for urate-lowering therapy, which helps reduce uric acid levels in the blood.
Patients must have achieved remission for at least 12 months based on specific criteria. Remission means that the symptoms of gout are under control.
Patients should be free of flares and/or clinically apparent tophi during the last 12 months. Flares are sudden attacks of pain, and tophi are lumps formed by uric acid crystals under the skin.
Serum urate levels should be ≤0.36 mmol/l at the start and all values in the last 12 months should not be >0.36 mmol/l. Serum urate is the level of uric acid in the blood.
Pain due to gout should be less than 2 on a 10-point scale at the start. This scale measures the intensity of pain, with 0 being no pain and 10 being the worst pain.
Patient’s global assessment of gout disease activity should be less than 2 on a 10-point scale at the start. This is a self-assessment of how active the gout is.
Patients must be 18 years or older and mentally competent.
Patients must sign a written informed consent form, agreeing to participate in the study.

Who Cannot Join the Study?

Patients who have a different condition than gout cannot participate. Gout is a type of arthritis that causes sudden pain, swelling, and redness in the joints.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the specific health criteria set for the study cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Sint Maartenskliniek Stichting	Ubbergen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	07.07.2024

Trial locations

Investigated drugs:

Urate Lowering Therapies are medications used to reduce the levels of uric acid in the blood. These therapies are commonly used in the treatment of gout, a condition characterized by painful joint inflammation due to the accumulation of uric acid crystals. The goal of these therapies is to prevent gout attacks and reduce the formation of tophi, which are deposits of uric acid crystals under the skin. In this clinical trial, the role of urate lowering therapies is to determine whether continuing or stopping these medications is more effective for patients whose gout is in remission.

Investigated diseases:

Gout

Gout – Gout is a type of arthritis characterized by sudden, severe attacks of pain, redness, and swelling in the joints, often affecting the big toe. It occurs when uric acid builds up in the blood, forming sharp crystals in the joints. These attacks can happen suddenly, often waking a person up in the middle of the night with the sensation that the big toe is on fire. The affected joint becomes hot, swollen, and so tender that even the weight of a bedsheet may seem intolerable. Over time, gout can lead to joint damage and the formation of tophi, which are lumps of uric acid crystals under the skin. The disease can progress with more frequent and severe attacks if not managed properly.

Trial ID:

2024-511111-13-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Gout Treatment: Comparing Allopurinol, Benzbromarone, and Febuxostat in Patients with Gout in Remission

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?