Adalimumab in JIA-associated Uveitis Stopping Trial

Open to people ages 2 years and up

(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 or CAU diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment) - Formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology - ≥12 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell, ≤0.5+ vitreous haze, no active retinal/choroidal lesions in either eye) - ≥ 12 consecutive months of controlled arthritis verified by a pediatric rheumatologist, if defined as JIA-associated uveitis - ≥12 consecutive months 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 antimetabolite (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 - 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) - Suitable, in the opinion of the Investigator, to continue treatment with adalimumab or placebo per regional labeling - No contraindications to receive adalimumab as per the local Summary of Product Characteristics (SmPC)

(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 - Use of NSAID eye drops within the last 90 days - 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) - 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 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 sex, race, or ethnicity restrictions for this study.