Adalimumab in JIA-associated Uveitis Stopping Trial

Inclusion Criteria (must meet all of the following to qualify):

- Stated willingness to comply with all study procedures and availability for the
duration of the study period

- ≥ 2 years of age

- History of JIA-associated uveitis or uveitis of the same phenotype (chronic,
asymptomatic, anterior uveitis) diagnosed prior to 18 years of age with no other
suspected etiology of uveitis

- ≥12 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell,
≤0.5+ vitreous haze, no active retinal/choroidal lesions in either eye, no macular
edema)

- ≥ 12 consecutive months of controlled arthritis verified by a pediatric rheumatologist

- ≥12 consecutive months and ≤5 years of treatment with adalimumab or a biosimilar of
adalimumab

- ≥180 days on a stable dose of adalimumab or a biosimilar; must be biweekly dose of
either 20mg (if<30kg) or 40mg (if ≥30kg)

- If on a biosimilar of adalimumab, ≥90 days on the biosimilar

- If on concomitant methotrexate, dose must be ≤25mg weekly and stable for ≥90 days

- If on concomitant mycophenolate mofetil, dose must be ≤3g daily and stable for ≥90
days

- If on topical corticosteroids, dose must be ≤2 drops prednisolone acetate 1% or
equivalent per day and 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 for ≥28 days prior to screening and
throughout study period (for males and females of reproductive age)

Exclusion Criteria (any one of these excludes the patient):

- Intraocular surgery in the past 90 days or planned surgery in the next 180 days

- 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 12 months

- Acute anterior uveitis characterized by redness and symptoms, including but not
limited to floaters, pain, and light sensitivity

- Pregnancy or lactation (a pregnancy test will be conducted at baseline and all
follow-up visits for females of reproductive age)

- Prior safety or tolerability issues with adalimumab

- History of cancer, tuberculosis, or hepatitis B

- Other medical condition expected to dictate treatment course during the study

- Any of the following abnormal lab values within 28 days prior to enrollment: leukocyte
count <2500, platelet count ≤75000, hemoglobin<9.0, AST or ALT ≥ 2 times the upper
limit of normal range, creatinine ≥1.5

There are no gender, race, or ethnicity restrictions for this study.