Adalimumab in JIA-associated Uveitis Stopping Trial

Ki vehet részt

• 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)

Ki nem vehet részt

• Intraocular surgery in the past 90 days or planned surgery in the next 12 months
• Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 12 months
• 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 Aminotransferase (AST) or Alanine Transferase (ALT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5; There are no sex, race, or ethnicity restrictions for this study
• Pregnancy or lactation (a pregnancy test will be conducted at baseline and all follow-up visits for females of reproductive age)
• Severe cataract or opacity preventing view to the posterior pole in both eyes
• Chronic hypotony (<5 mmHg for ≥90 days) in either eye
• 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
• Presence of intraretinal or subretinal fluid in either eye