CompletedPhase IVInterventional

Treatment of inflammation inside the eye caused by an overactive immune system (autoimmune uveitis) using adalimumab

Autoimmune uveitis happens when the body's natural defences attack the inside of the eye. This causes painful swelling and can damage your sight. Right now, doctors often prescribe steroid tablets to keep the condition under control. While steroids work well, taking high doses for a long time can lead to serious health problems, such as infections and heart issues. The ASTUTE study is looking at whether a medicine called adalimumab can help. Adalimumab targets and calms down the body's inflammation signals. In this trial, all patients first receive adalimumab for 16 weeks to help bring down their steroid dose. Those who respond well then move to the main study for up to 30 months, receiving either adalimumab or a dummy injection alongside low-dose medication. This helps researchers find out if adalimumab safely prevents uveitis from coming back.

At a glance

Status

Completed

Phase

Phase IV

Sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Enrolment target

174

Start

01 Dec 2020

Estimated completion

07 Jun 2024

Autoimmune non-infectious uveitis

What is this study about?

Autoimmune uveitis is a rare condition where the body's immune system attacks healthy tissue at the back of the eye. This swelling can affect the retina—the light-sensitive layer that helps you see—and can cause permanent sight loss if left untreated. For many people, high doses of steroid tablets are the only way to stop the inflammation. However, staying on high-dose steroids for months or years brings tough side effects, including high blood pressure, weakened bones, mood changes, and a higher risk of heart disease.

Doctors are searching for treatments that keep the eyes healthy without the need for large amounts of steroids. Adalimumab is an established medicine used for other inflammatory diseases. It works by targeting and blocking specific proteins that cause inflammation, helping to calm the immune system.

The ASTUTE study aims to see if adding adalimumab to standard care helps people with uveitis stay well on much lower, safer steroid doses. By comparing adalimumab against a dummy treatment (placebo), researchers can find out whether it truly stops flare-ups and provides good value for the NHS, potentially leading to better, safer treatment options in the future.

Key takeaways

The trial tests whether adalimumab helps control autoimmune uveitis while reducing steroid use.
Steroids are effective, but long-term high doses carry serious health risks.
All participants receive adalimumab for the first 16 weeks to help lower their steroid dose.
Patients who do well will then be randomly assigned to continue adalimumab or switch to a dummy injection.
Your eyes will be monitored frequently by specialists throughout the study to keep your vision safe.

Who may be eligible?

This trial is open to adults aged 18 and over who have non-infectious autoimmune uveitis that threatens their sight. To take part, you must currently be taking or starting a moderate to high daily dose of steroid tablets (more than 5 milligrams of prednisolone per day) to manage your eye condition. Women of childbearing age must have a negative pregnancy test and agree to use reliable contraception during the trial and for five months afterwards.

You cannot take part if your uveitis is already well controlled on a low steroid dose of 5 milligrams or less per day, or if you take high-dose steroids for another illness. People who have certain existing conditions cannot join, including active tuberculosis, severe infections, multiple sclerosis, uncontrolled glaucoma, significant heart failure, or a history of cancer within the last five years. People with viral infections such as HIV, hepatitis B, or hepatitis C are also excluded for safety reasons.

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.

I am aged 18 or older.
I have been diagnosed with autoimmune (non-infectious) uveitis that puts my sight at risk.
I currently take more than 5mg of oral prednisolone (steroids) daily, or need to start taking it.
I do not have multiple sclerosis, active tuberculosis, or severe heart failure.
I have not had cancer treatment within the last five years.
I am willing to use reliable contraception during the trial if applicable.

Answer every question to see your result.

What does participation involve?

If you join the trial, your participation will happen in two stages over roughly 12 to 30 months. In the first 16-week period, every participant is given adalimumab as an injection under the skin. During these 16 weeks, doctors will work with you to gently reduce your steroid tablets to a low, safe dose.

If your eyes remain calm on the lower steroid dose, you will enter the main study. Here, a computer will assign you by chance to receive either regular adalimumab injections or a dummy injection (placebo), taken alongside your low-dose medicines. Neither you nor your eye doctor will know which one you are receiving. You will attend regular hospital appointments for eye scans, sight checks, blood tests, and health questionnaires. This close monitoring ensures that if your eye inflammation flares up at any point, your care team can spot it immediately and adjust your treatment.

Potential risks and benefits

Taking part may allow you to try a newer treatment and lower your daily steroid intake, reducing your risk of steroid-related side effects. However, benefits cannot be guaranteed. The injections can cause mild skin irritation, bruising, or soreness. Adalimumab can also lower your resistance to infections. If you are placed in the dummy treatment group, your uveitis might flare up, though your eyes will be monitored very closely to protect your vision. Joining the trial is entirely voluntary, and you are free to leave at any time without your regular NHS care being affected.

Locations (18)

University Hospitals Bristol NHS Foundation Trust
Unverified
Bristol, England
John Radcliffe Hopsital
Unverified
Oxford, England
Royal Liverpool Hospital
Unverified
Liverpool, England
Norfolk and Norwich University Hospital
Unverified
Norwich, England
York Hospital
Unverified
York, England
Leicester Royal Infirmary
Unverified
Leicester, England
Queen Elizabeth Hospital
Unverified
Birmingham, England
Addenbrookes Hospital
Unverified
Cambridge, England
Queens Medical Centre
Unverified
Nottingham, England
Southampton General Hospital
Unverified
Southampton, England
St. James's University Hospital
Unverified
Leeds, England
Moorfields Eye Hospital
Unverified
London, England

Common questions

What is adalimumab?

Adalimumab is a medicine given by injection under the skin. It works by blocking a specific protein in the body that triggers inflammation, helping to calm down an overactive immune system.

Why is a dummy injection (placebo) used?

A dummy injection looks identical to the real medicine but contains no active drug. Comparing adalimumab against a placebo is the fairest way to prove whether the medicine truly keeps eye inflammation away.

Will I know if I am getting the real drug or the placebo?

In the main phase, neither you nor your doctors will know. This ensures results remain unbiased. However, your doctors can find out quickly in an emergency.

What happens if my eye condition worsens during the trial?

You will have regular, thorough eye checks. If the doctor notices signs that your uveitis is returning, they can step in right away and provide standard treatments to protect your sight.

Can I leave the study if I change my mind?

Yes. Taking part is completely your choice. You can withdraw at any time without giving a reason, and your regular eye care will continue as normal.

How to find out more

Kirsty Lanyon

astute-trial@bristol.ac.uk +44 (0)117 455 1343 Official trial record

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