Not yet recruitingPHASE4INTERVENTIONAL

Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

This study aims to find out if children and young adults with well-controlled uveitis (eye inflammation) linked to juvenile idiopathic arthritis (JIA) or chronic anterior uveitis can safely have adalimumab injections less frequently. Adalimumab is a medicine that helps manage these conditions. The main goal is to see if reducing how often the injections are given will still prevent eye or joint inflammation from returning. Researchers will test different injection schedules, from every 2 weeks to every 12 weeks, to understand how this affects disease control. Participants will have regular check-ups, tests, and keep a diary of their medication.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Nisha Acharya

Enrolment target

160

Start

01 Sep 2026

Estimated completion

01 Nov 2030

Juvenile Idiopathic Arthritis Associated Uveitis Uveitis, Anterior

What is this study about?

This study is about a medicine called adalimumab, or a very similar version of it (a biosimilar). These medicines are used to treat certain inflammatory conditions, like eye inflammation (uveitis) linked to a type of childhood arthritis called juvenile idiopathic arthritis (JIA), or another eye condition called chronic anterior uveitis. These conditions can cause pain and damage if not well controlled.

Many young people with these conditions take adalimumab injections regularly, usually every two weeks, and their symptoms are now well under control. The doctors running this study want to see if it's possible for these young people to take their injections less often – maybe every 4, 8, or even 12 weeks – without their symptoms coming back. This could make life easier for them, with fewer injections.

The study will carefully compare different injection schedules. By doing this, the researchers hope to find the best way to keep the conditions under control while reducing the burden of treatment. This is important because it could lead to new guidelines for how this medicine is used in the future, potentially improving the quality of life for many young patients.

Key takeaways

This study explores taking adalimumab injections less often for eye and joint inflammation.
It's for children and young adults whose conditions are already well-controlled.
Different injection schedules (every 2, 4, 8, or 12 weeks) will be tested.
Participants will have regular check-ups, tests, and keep a medication diary.
The main goal is to find a way to reduce injections while keeping symptoms away.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for children and young adults who have been diagnosed with either juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior uveitis before they turned 16. You can be older than 16 when you join the study, but your diagnosis needed to be in childhood.

To be considered, your eye inflammation and, if applicable, your arthritis, must have been well controlled for at least two years. You also need to have been taking adalimumab or a similar medicine for at least two years with a stable dose for the past six months, and still be able to get this medicine. You'll also need to be at least 2 years old and weigh at least 15 kilograms.

There are also some other important points: you should be able to attend all study visits, agree to avoid live vaccines, limit alcohol, and if you are able to have children, agree to use effective contraception throughout the study. Your study doctor will make the final decision on whether the study is right for you.

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.

Were you diagnosed with JIA-associated uveitis or chronic anterior uveitis before age 16?
Have your eye and joint conditions (if applicable) been well-controlled for at least 2 years consistently?
Have you been taking adalimumab or a similar medicine for at least 2 years with a stable dose recently?
Are you at least 2 years old and weigh at least 15kg?
Are you able to attend study appointments every 6 weeks for about 6 months, plus one later visit?
Are you able to get your regular supply of adalimumab or biosimilar medication?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue taking your adalimumab (or biosimilar) injections, but the timing between your doses might be changed. You could be asked to take your injections every 2, 4, 8, or 12 weeks. You will need to come to the study clinic for check-ups every 6 weeks over a period of 24 weeks (about 6 months). There will also be an extra follow-up visit at 48 weeks (about 11 months after starting).

During these visits, doctors and nurses will do check-ups, conduct tests (which might include blood tests or eye exams), and ask you to fill out questionnaires about how you are feeling. You will also be asked to keep a diary to record when you take your adalimumab/biosimilar injections and any other medicines you take for your eye or joint conditions. The total time you would be actively involved in the study part with regular visits is about 6 months, with one final check-up nearly a year after starting.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as continued close monitoring of your condition by specialists and potentially finding that you can take your medication less often, which could improve your daily life. However, there's a possibility that increasing the time between your injections might cause your eye inflammation or arthritis to return or worsen. All medical treatments carry some risks, and the study team will monitor you very closely for any changes or side effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

University of California, Los Angeles
Verified postcode
Los Angeles, United States
University of California, Davis
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Sacramento, United States
University of California, San Francisco
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San Francisco, United States
University of Miami
Verified postcode
Miami, United States
Children's Mercy Hospital
Verified postcode
Kansas City, United States
Cincinnati Children's Hospital
Verified postcode
Cincinnati, United States
Vanderbilt University Medical Center
Verified postcode
Nashville, United States
University of Texas, Austin
Verified postcode
Austin, United States
University of Utah Health
Verified postcode
Salt Lake City, United States
Meyer Children's Hospital
Verified postcode
Florence, Italy
University Hospitals Bristol and Weston
Verified postcode
Bristol, United Kingdom
University Hospitals of Leicester
Verified postcode
Leicester, United Kingdom

Common questions

What exactly is uveitis?

Uveitis is when the middle layer of your eye, called the uvea, becomes inflamed. This can cause pain, redness, blurred vision, and sensitivity to light.

What is juvenile idiopathic arthritis (JIA)?

JIA is a type of arthritis that affects children. It causes pain, swelling, and stiffness in the joints. Sometimes, it can also affect the eyes, leading to uveitis.

What is adalimumab?

Adalimumab is a medicine given by injection that helps to calm down the immune system. It's used to treat inflammatory conditions like uveitis and arthritis by reducing inflammation in the body.

Will I have to pay for the adalimumab during the study?

The study description mentions the 'ability to continue to obtain commercial supply of adalimumab or biosimilar,' which implies you'll continue to get your medication as you normally would, for instance, through your usual prescription or healthcare provider.

What happens if my condition gets worse during the study?

The study team will be monitoring you very closely. If your condition shows signs of worsening, they will address it immediately, which may include adjusting your medication schedule or taking you out of the study to ensure you receive the best care.

How to find out more

Nisha Acharya, MD MS

nisha.acharya@ucsf.edu 415-476-8131 Official trial record

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