Adalimumab in JIA-associated Uveitis Stopping Trial
The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA).
Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial
UveitisJIAAdalimumabContinue adalimumabStop adalimumab
You can join if…
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-associated uveitis or uveitis of the same phenotype (chronic, asymptomatic, anterior uveitis) diagnosed prior to 18 years of age with no other suspected etiology of uveitis
- ≥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 and ≤5 years 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)
You CAN'T join if...
(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
- 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
There are no gender, race, or ethnicity restrictions for this study.
- University of California, San Francisco
not yet accepting patients
San FranciscoCalifornia94143United States
- Children's Hospital Los Angeles
not yet accepting patients
Los AngelesCalifornia90027United States
- not yet accepting patients
- Start Date
- Completion Date
- Nisha Acharya
- Phase 3
- Study Type
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03816397.