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 diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)
• ≥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 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)
• A negative tuberculosis (TB) test within the past 12 months or a positive test for TB with a history of completed treatment for latent TB
• 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)