Adalimumab in JIA-associated Uveitis Stopping Trial

Inclusion Criteria

• •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)