Adalimumab in JIA-associated Uveitis Stopping Trial



Status:Not yet recruiting
Conditions:Cervical Cancer, Ocular
Therapuetic Areas:Oncology, Ophthalmology
Healthy:No
Age Range:2 - Any
Updated:1/27/2019
Start Date:July 2019
End Date:February 2023
Contact:Nisha Acharya, MD MS
Email:nisha.acharya@ucsf.edu
Phone:415-476-8131

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Adalimumab in Juvenile Idiopathic Arthritis-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).


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-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)

Exclusion Criteria (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.
We found this trial at
9
sites
Cincinnati, Ohio 45229
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Jennifer Thorne, MD PhD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Thomas Lee, MD
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Parkville,
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50 North Medical Drive
Salt Lake City, Utah 84132
Principal Investigator: Albert Vitale, MD
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Salt Lake City, UT
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San Francisco, California 94143
Principal Investigator: Nisha Acharya, MD MS
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San Francisco, CA
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Michelle Cabrera, MD
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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