Summary

for people ages 2 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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).

Official Title

Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial

Keywords

UveitisJIAAdalimumabContinue adalimumabStop adalimumab

Eligibility

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.

Locations

  • University of California, San Francisco not yet accepting patients
    San FranciscoCalifornia94143United States
  • Children's Hospital Los Angeles not yet accepting patients
    Los AngelesCalifornia90027United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Nisha Acharya
ID
NCT03816397
Phase
Phase 3
Study Type
Interventional
Last Updated