Adalimumab Dose Adjustment for Pediatric Uveitis Treatment

This study is looking at whether children and young adults with well-controlled uveitis (eye inflammation) linked to juvenile idiopathic arthritis (JIA) or chronic anterior uveitis can safely take adalimumab (or a similar biosimilar medicine) less often. Adalimumab is an injectable medicine that helps control inflammation. Researchers want to see if giving injections every 2, 4, 8, or 12 weeks can still keep the disease under control, preventing eye or joint inflammation from returning. The study plans to enroll 160 participants aged 2 years and older who have a history of JIA or chronic anterior uveitis diagnosed before age 16. The main goal is to measure how often treatment failure occurs over 24 weeks.

Study design: This is an interventional study planning to enroll 160 participants. It will compare different schedules for adalimumab/biosimilar injections.
What's involved: Participants will take adalimumab/biosimilar injections every 2, 4, 8, or 12 weeks.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint measures treatment failure from baseline to 24 weeks post-randomization.

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Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

Not Yet Recruiting

PHASE4Ages 2+InterventionalTreatment

Nisha Acharya

~160 participants

Updated 2026-07-13 on ClinicalTrials.gov

What's tested:Adalimumab/Biosimilar

At a glance

Recruiting sites

0 of 18 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Cumulative Incidence of Treatment Failure

Measured over From baseline to 24 weeks post-randomization

Conditions

Juvenile Idiopathic Arthritis Associated Uveitis

Uveitis, Anterior

Where it's being run

18 sites across 9 states

United Kingdom8

California3

Florida1

Missouri1

Ohio1

Tennessee1

Texas1

Utah1

Study leadership

Nisha Acharya, MD MS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Nisha Acharya, MD MS

[email protected]

415-476-8131

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Eligibility criteria

Inclusion

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

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

What this trial measures

Cumulative Incidence of Treatment FailureFrom baseline to 24 weeks post-randomization
Proportion of participants in each treatment arm experiencing treatment failure by Week 24. Treatment failure is defined by recurrence of ocular inflammation (at least one of the following in at least one eye): * \>0.5+ anterior chamber (AC) cell at a single visit as defined by the Standardization of Uveitis Nomenclature (SUN) criteria * \>0.5+ vitreous haze at a single visit * Active retinal/choroidal inflammation and/or macular edema in either eye at a single visit. Macular edema is defined as central subfield thickness on optical coherence tomography (OCT) \>2 standard deviations above normal thickness (\>320µm on Spectralis or \>300µm on Zeiss or Topcon) and having a greater than 20% increase from baseline and/or presence of intraretinal or subretinal fluid. Treatment failure may also be defined as recurrence of joint disease persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.

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