AuthorisedTherapeutic use (Phase IV)Interventional

Evaluation of a therapeutic de-eScalation strategy based on therapeutic drug MOnitOring in chronic non-infectious uveitis Treated witH adalimumab

This study is investigating a new way to manage chronic non-infectious uveitis, a condition causing ongoing eye inflammation. It focuses on people being treated with a medicine called Humira (adalimumab). Researchers want to see if carefully adjusting the Humira dose, based on how much of the drug is in a person's blood, can still keep the eye inflammation completely under control for 48 weeks. They are also checking to make sure participants don't get new infections during this period. The study aims to find the best way to use Humira effectively while potentially reducing the amount of medicine needed, which could be beneficial for patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Saint Etienne

Enrolment target

320

Start

13 Feb 2025

noninfectious uveitis

What is this study about?

This study, called a "Phase IV" study, is looking closely at how an existing medicine called Humira (adalimumab) is used in people with chronic non-infectious uveitis. Uveitis is a condition where the middle layer of the eye becomes inflamed, which can cause pain, redness, blurred vision, and sometimes lead to serious vision problems if not treated.

The main idea behind this study is to see if doctors can safely reduce the dose of Humira for some patients, without their eye inflammation coming back. They will do this by regularly checking the level of Humira in a patient's blood. This is important because using the lowest effective dose can sometimes reduce side effects and might be more convenient for patients in the long run. The study will track patients for 48 weeks to see if their eyes remain completely free of inflammation and if they avoid infections.

In addition to checking for inflammation and infections, the researchers will also be looking at other important things. This includes how patients' quality of life is affected, measuring how well their vision functions, and looking at the costs involved. They will also check for antibodies that the body might produce against Humira, which could affect how well the medicine works. All of these details will help doctors understand the best way to use Humira for people with chronic non-infectious uveitis.

Key takeaways

Exploring if Humira dose can be lowered for chronic eye inflammation.
Blood tests will guide dose adjustments of Humira.
Aims for complete control of eye inflammation.
Will monitor for infections over 48 weeks.
Looks at quality of life and costs too.

Who may be eligible?

This study is designed for adults, aged 18 and over, who have chronic non-infectious uveitis. This means they have long-lasting eye inflammation that isn't caused by an infection.

Both men and women can take part in this research. The most important thing is that participants are currently being treated with Humira (adalimumab) for their eye condition.

Further specific criteria will be checked by the study team, such as your medical history and current health status, to make sure the study is a good fit for you and that it's safe for you to participate.

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.

Are you 18 years old or older?
Do you have chronic non-infectious uveitis?
Are you currently being treated with Humira (adalimumab) for your uveitis?
Are you able to attend regular clinic appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would continue to receive your Humira injections, either through a pre-filled pen or syringe. The main difference would be that your doctors would regularly check the levels of Humira in your blood. Based on these blood test results, they might adjust your dose of Humira, either by keeping it the same or by carefully reducing it. Throughout the 48-week study period, you would have regular visits where doctors would examine your eyes very carefully to make sure there's no inflammation. They would also monitor you for any signs of infection and ask you questions about your general health and how your vision is affecting your daily life. The study will last for up to 48 weeks, which is about 11 months.

Potential risks and benefits

Participating in this study might offer a potential benefit if a reduced dose of Humira can still effectively control your uveitis, potentially leading to fewer side effects over time. However, there's also a risk that reducing the dose might not be enough to control your inflammation, or that you could experience an infection. All medical procedures carry some risks, and you would be closely monitored for any changes to your health. You would be fully informed of all known and potential risks before deciding to join, and you would always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is chronic non-infectious uveitis?

It's an ongoing inflammation inside your eye that isn't caused by a germ like a virus or bacteria.

What is Humira?

Humira (adalimumab) is a medicine used to reduce inflammation in various conditions, including some types of eye inflammation.

What does 'therapeutic drug monitoring' mean?

It means doctors will measure the amount of Humira in your blood. This helps them decide the best dose for you.

How long will the study last?

The study will last for about 48 weeks, which is just under a year.

Will I still get my usual eye care if I join?

Yes, you will continue to receive close medical attention and care for your eye condition throughout the study.