Could fewer injections keep kids' eye inflammation in check?
NCT ID NCT07699107
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This trial investigates whether children and young adults with juvenile idiopathic arthritis (JIA)-related uveitis can safely take adalimumab injections less frequently without their eye or joint inflammation returning. Participants are assigned to receive injections every 2, 4, 8, or 12 weeks and are monitored for 24 weeks, with a follow-up at 48 weeks. The goal is to find the least frequent dosing schedule that still keeps the disease under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adalimumab (a biologic drug that reduces inflammation)
- What this could lead to
- If successful, this could allow children with JIA-related uveitis to take fewer injections while still controlling eye and joint inflammation.
- What could go wrong
- This is a Phase 4 trial with 160 participants, so results may not apply to all patients. Less frequent dosing might lead to disease flare-ups in some children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study period * History of juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU), diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment) * ≥2 years of age (per FDA approval for use in children with polyarticular JIA) * Weight must be ≥15kg * Formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology * ≥24 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions in either eye) * ≥24 consecutive months of controlled arthritis verified by a pediatric rheumatologist if defined as JIA-associated uveitis * ≥24 consecutive months of treatment with adalimumab or biosimilar of adalimumab * ≥180 days on a stable dose of adalimumab or biosimilar of adalimumab; dose must be no greater than 20mg (if weight \<30kg), or 40mg (if weight ≥30kg), injected every two weeks * If on biosimilar of adalimumab, ≥90 days on the biosimilar * Ability to continue to obtain commercial supply of adalimumab or biosimilar * If on a conventional disease-modifying anti-rheumatic drug (cDMARD) (injectable or oral methotrexate, mycophenolate mofetil, azathioprine, or leflunomide), dose must be ≤25 mg weekly for methotrexate, ≤3 g daily for mycophenolate mofetil, ≤250 mg daily for azathioprine, or ≤20 mg daily for leflunomide; dose and route of administration must be stable for ≥90 days * Willingness to limit consumption of alcohol during the study period * Agreement to avoid live attenuated vaccinations * Agreement to use highly effective contraception or abstinence for ≥28 days prior to screening and throughout the study period (for males and females of reproductive age) * Suitable, in the opinion of the Investigator, to continue treatment with adalimumab/biosimilar per regional labeling Exclusion Criteria: * History of acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity * Intraocular surgery in the past 90 days or planned surgery in the next 24 weeks * Severe cataract or opacity preventing view to the posterior pole in both eyes * Chronic hypotony (\<5mmHg for ≥90 days) in either eye * Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 24 weeks * Use of topical corticosteroid eye drops within the last 90 days * Use of nonsteroidal anti-inflammatory drug (NSAID) eye drops within the last 90 days * Pregnancy or lactation (a pregnancy test will be conducted at baseline and follow-up visits for females post-menarche) * Presence of intraretinal or subretinal fluid in either eye * Prior safety or tolerability issues with adalimumab * History of cancer, active tuberculosis, or hepatitis B * Other medical condition expected to dictate treatment course during the study * Any of the following laboratory test results on their most recent tests within the past 90 days prior to screening/enrollment: leukocyte count \<2500, platelet count ≤75000, hemoglobin\<9.0, aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
18 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alder Hey Children's Hospital
Liverpool, L14 5AB, United Kingdom
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Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
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Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
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Great North Children's Hospital
Newcastle upon Tyne, NE1 4LP, United Kingdom
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Great Ormond Street Hospital
London, WC1N 3JH, United Kingdom
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Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
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Meyer Children's Hospital
Florence, 50139, Italy
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Norfolk and Norwich University Hospital
Norwich, NR4 6TZ, United Kingdom
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Sheffield Children's Hospital
Sheffield, S10 2TQ, United Kingdom
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University Hospitals Bristol and Weston
Bristol, BS1 3NU, United Kingdom
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University Hospitals of Leicester
Leicester, LE1 5WW, United Kingdom
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University of California, Davis
Sacramento, California, 95817, United States
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University of California, Los Angeles
Los Angeles, California, 90095, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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University of Miami
Miami, Florida, 33136, United States
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University of Texas, Austin
Austin, Texas, 78712, United States
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University of Utah Health
Salt Lake City, Utah, 84132, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
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