CompletedNot ApplicableInterventional

Treat to target in gout

Gout is a common form of arthritis that affects around one in forty people across the UK. It happens when high levels of a substance called uric acid build up in the body and form sharp crystals inside the joints. These crystals can cause sudden attacks of severe pain, redness, and swelling, known as flares. Painkillers can soothe flare-ups, but they do not clear the crystals away. A daily tablet called allopurinol works to lower uric acid levels and slowly dissolve these crystals over time. This study tests whether closely adjusting allopurinol doses to reach a specific blood target works better at preventing flares than standard GP care. Researchers want to see if this targeted approach improves daily well-being and provides good value for the NHS. Participants are followed for up to four years to see which method works best.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Nottingham

Enrolment target

466

Start

30 Jun 2019

Estimated completion

02 May 2024

Gout

What is this study about?

Gout is a painful condition that affects thousands of people across the UK. It develops when a normal waste product called uric acid builds up in the blood. If levels get too high, tiny grit-like crystals form inside joints like the big toe, ankle, or knee. From time to time, these crystals irritate the joint lining, triggering an attack of severe pain, redness, and swelling that can last for a week or two.

Doctors often prescribe anti-inflammatory painkillers to calm down these flares. While painkillers help soothe the pain, they do not clear the crystals out of the joint. Another medicine, called allopurinol, works differently. It stops the body from making as much uric acid. Over time, lowering uric acid levels allows the crystals to dissolve completely. However, doctors are not yet completely sure if aiming for a specific blood target reduces future attacks better than standard care.

This research study aims to find the most effective way to protect people from gout flares. It compares a focused plan—where a practice nurse regularly checks blood tests and adjusts allopurinol doses to hit a precise target—against the usual care patients normally receive from their GP.

The findings will help the NHS understand how best to treat gout long term. By finding out whether a targeted approach cuts down attacks, improves general well-being, and saves money on emergency appointments, the trial could help shape future gout guidelines for everyone in the UK.

Key takeaways

Compares a targeted dose-adjustment plan for allopurinol with standard GP care.
Open to adults aged 18 and over who had at least one gout flare in the past year.
Involves three main clinic visits over two years, plus nurse visits if adjusting medication.
Keeps track of gout flares and overall health for up to four years in total.
Aims to help the NHS decide the best and most cost-effective way to manage gout.

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with gout and have experienced at least one flare-up in the past 12 months. Your blood test must also show a uric acid level high enough to benefit from treatment. Both men and women can take part.

To keep you safe, the study is not suitable for people who have had a bad reaction or allergy to allopurinol in the past. You also cannot join if you have severe kidney disease, liver disease (cirrhosis), or other types of joint disease such as rheumatoid arthritis.

People receiving cancer treatments, those taking daily steroid tablets or immune-suppressing drugs, and anyone who is pregnant, breastfeeding, or planning a pregnancy within the next four years are also unable to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

You are 18 years of age or older.
You have been diagnosed with gout and had a flare-up in the last 12 months.
You have never had a severe allergic reaction to allopurinol.
You do not have severe kidney failure or liver cirrhosis.
You are not pregnant, breastfeeding, or planning a pregnancy in the next 4 years.

Answer every question to see your result.

What does participation involve?

If you join, a computer will place you by chance into one of two groups. One group receives usual care from their GP surgery, which may include allopurinol if your doctor thinks it is needed. The other group receives a targeted care plan, with regular nurse visits to gradually adjust your allopurinol dose until your uric acid hits a specific target.

Everyone in the study has three main research appointments over two years: one at the start, one after a year, and one at two years. During these visits, the team measures your height, weight, and blood pressure, and takes blood samples to check your kidneys and uric acid levels. You will fill in short questionnaires about your well-being and keep a diary of any gout flares.

After the first two years, the team will keep in touch for another two years to monitor your health records. In total, your participation lasts up to four years.

Potential risks and benefits

Taking part gives you regular health checks and could help you better control your gout, though direct personal benefits cannot be guaranteed. The medicines used in the trial are already widely prescribed and well-known to doctors. As with any drug, allopurinol can occasionally cause mild side effects like a skin rash or stomach upset, but serious problems are very rare. You are free to leave the trial at any time without giving a reason, and doing so will never affect your standard NHS care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

East Midland Clinical Research Network
City only
Leicester, England
West Midland Clinical Research Network
City only
Stafford,, England
Wessex Clinical Research Network
City only
Southampton, England
London CRNs (Noclar, North London, South London, and Lutton Essex and Herts)
City only
London, England
Yorkshire and Humber CRN
City only
Rotherham, England
Thames Valley and South Midlands CRN
Unverified
Oxford, England

Common questions

What is allopurinol?

Allopurinol is a widely used tablet that lowers uric acid levels in the blood to help stop gout crystals forming.

Will I have to pay for the study treatment?

No, taking part in NHS clinical trials is free, and your study appointments and tests are covered.

Can I choose which group I am in?

No, a computer decides your group by chance so the comparison between the two approaches remains completely fair.

What happens if I get a gout flare during the study?

You will treat your flare with your usual pain relief as advised by your doctor, and record the attack details in your study diary.

Can I leave the study if I change my mind?

Yes, taking part is entirely voluntary. You can stop participating at any point, and your standard medical care will continue as normal.

How to find out more

Steff Garvin

s.garvin@keele.ac.uk +44 (0)1782 732950 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.