Principal Investigator: Albert Vitale
Keywords: JIA , Uveitis / ocular inflammation , Medical treatment Department: Ophthalmology-Services
IRB Number: 00122187 Co Investigator: Aimee Hersh
Specialty: Ophthalmology
Sub Specialties: Uveitis
Recruitment Status: Recruiting

Contact Information

Kimberley Wegner
kimberley.wegner@hsc.utah.edu
801-581-6265

Simple Summary

To develop evidence for the safety and utility of stopping adalimumab treatment in JIA-associated uveitis patients

Inclusion Criteria

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

  • ≥2 years of age (per FDA approval for use in children with polyarticular JIA)

  • History of JIA diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)

  • Formal diagnosis of JIA-associated uveitis 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, no macular edema)

  • ≥12 consecutive months of controlled arthritis verified by a pediatric rheumatologist (see MOP Section 2.4.1 for definition of controlled arthritis)

  • ≥12 consecutive months of treatment with adalimumab or a biosimilar

  • ≥180 days on a stable dose of adalimumab or a biosimilar of adalimumab; must be biweekly dose of no greater than 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)

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

Exclusion Criteria

  • 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

Participant Reimbursement

$30 per visit up to a maximum of $330 for completing all protocol visits