Adalimumab in JIA-associated Uveitis Stopping Trial
United States87 participantsStarted 2020-03-15
Plain-language summary
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) or chronic anterior uveitis (CAU).
Who can participate
Age range2 Years
SexALL
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Inclusion Criteria (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 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 avoi…
What they're measuring
1
Time to Treatment Failure
Timeframe: From baseline until 48 weeks post-randomization