Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

Starting soon · Phase 4

Conditions studied: Juvenile Idiopathic Arthritis Associated Uveitis, Uveitis, Anterior

In brief

The goal of this clinical trial is to learn whether children and young adults with well-controlled juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior uveitis can safely take adalimumab (or biosimilar) injections less often while maintaining control of their disease. The main question it aims to answer is: can adalimumab/biosimilar injections be given less frequently without uveitis (eye inflammation) or arthritis (joint inflammation) returning? Researchers will compare adalimumab/biosimilar injection schedules of every 2 weeks, 4 weeks, 8 weeks, and 12 weeks to determine how injection frequency affects disease control. Participants will: * Take adalimumab/biosimilar injections every 2, 4, 8, or 12 weeks. * Attend study visits every 6 weeks over 24 weeks, with an additional follow-up visit at 48 weeks for checkups, tests, and questionnaires. * Keep a diary of how often they take adalimumab/biosimilar and other drugs they take for their uveitis/arthritis.

Key facts

Study ID

NCT07699107

Run by

Nisha Acharya

People needed

160

Starts

2026-09-01

Expected to finish

2030-11-01

Last updated by the study team

2026-07-13

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Davis — Sacramento, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas, Austin — Austin, Texas, United States
• University of Utah Health — Salt Lake City, Utah, United States
• Meyer Children's Hospital — Florence, Italy
• University Hospitals Bristol and Weston — Bristol, United Kingdom
• University Hospitals of Leicester — Leicester, United Kingdom
• Alder Hey Children's Hospital — Liverpool, United Kingdom
• Great Ormond Street Hospital — London, United Kingdom
• Manchester University NHS Foundation Trust — Manchester, United Kingdom
• Great North Children's Hospital — Newcastle upon Tyne, United Kingdom
• Norfolk and Norwich University Hospital — Norwich, United Kingdom
• Sheffield Children's Hospital — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.