Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

ClinicalTrials.gov ID

NCT07699107

Lead Sponsor

Nisha AcharyaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

160Estimated

Last Update Posted

Jul 13, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

May 2030Estimated

Completion Date

Nov 2030Estimated

Official Title

Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

Brief Summary

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.

• Juvenile Idiopathic Arthritis Associated Uveitis
• Uveitis, Anterior

• Adalimumab/Biosimilar

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Nisha AcharyaOTHER

Collaborators

National Eye Institute (NEI)NIH

National Institutes of Health (NIH)NIH

University of California, San FranciscoOTHER

University of California, DavisOTHER

University of California, Los AngelesOTHER

Children's Hospital Medical Center, CincinnatiOTHER

Children's Mercy Hospital Kansas CityOTHER

University of MiamiOTHER

University of UtahOTHER

University of Texas at AustinOTHER

Vanderbilt University Medical CenterOTHER

University Hospitals Bristol and Weston NHS Foundation TrustOTHER

Alder Hey Children's NHS Foundation TrustOTHER

Great Ormond Street Hospital for Children NHS Foundation TrustOTHER

Norfolk and Norwich University Hospitals NHS Foundation TrustOTHER

Manchester University NHS Foundation TrustOTHER_GOV

Sheffield Children's NHS Foundation TrustOTHER

University Hospitals, LeicesterOTHER

Meyer Children's Hospital IRCCSOTHER

Newcastle-upon-Tyne Hospitals NHS TrustOTHER

Moorfields Eye Hospital NHS Foundation TrustOTHER

parisaemami@gmail.com916-734-6602

Nisha.Acharya@ucsf.edu415-476-8131

sxl1789@med.miami.edu

edstahl@cmh.edu816-960-8000

Sheila.Angeles-Han@cchmc.org513-517-2057

sapna.gangaputra@vumc.org615-936-3921

eric.crowell@austin.utexas.edu512-495-5899

marissa.larochelle@hsc.utah.edu801-581-2352

gabriele.simonini@unifi.it(+39) 05 55662924

avramanan@hotmail.com+44 117 3420149

arani.sridhar@uhl-tr.nhs.uk

Jose.Gonzalez-Martin@alderhey.nhs.uk+44 151 752 5839

elena.moraitis@gosh.nhs.uk

jane.ashworth@mft.nhs.uk+44 794 461 6005

Sharmila.Jandial@nhs.net+44 191 282 5318

narman.puvanachandra@nnuh.nhs.uk+44 1603288374

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