Status:
COMPLETED
Adalimumab in JIA-associated Uveitis Stopping Trial
Lead Sponsor:
Nisha Acharya
Collaborating Sponsors:
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Conditions:
Uveitis
JIA
Eligibility:
All Genders
2+ years
Phase:
PHASE4
Brief 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 w...
Detailed Description
Background: Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic pediatric ocular inflammatory condition that can result in visual impairment. Chronic anterior uveitis (CAU) does not ha...
Eligibility Criteria
Inclusion
- 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 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)
- Suitable, in the opinion of the Investigator, to continue treatment with adalimumab or placebo per regional labeling
- No contraindications to receive adalimumab as per the local Summary of Product Characteristics (SmPC)
- Exclusion Criteria (any one of these excludes the patient):
- Intraocular surgery in the past 90 days or planned surgery in the next 12 months
- Severe cataract or opacity preventing view to the posterior pole in both eyes
- Chronic hypotony (\<5 mmHg for ≥90 days) in either eye
- Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 12 months
- Use of NSAID eye drops within the last 90 days
- 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)
- Presence of intraretinal or subretinal fluid in either eye
- Prior safety or tolerability issues with adalimumab
- History of cancer, active tuberculosis, or hepatitis B
- Other medical condition expected to dictate treatment course during the study
- Any of the following laboratory test results on their most recent tests within the past 90 days prior to screening/enrollment: leukocyte count \<2500, platelet count ≤75000, hemoglobin \<9.0, Aspartate Aminotransferase (AST) or Alanine Transferase (ALT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5
- There are no sex, race, or ethnicity restrictions for this study.
Exclusion
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03816397
Start Date
March 15 2020
End Date
April 3 2025
Last Update
May 11 2025
Active Locations (21)
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1
University of California, Davis
Sacramento, California, United States, 95817
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
University of Colorado Denver
Aurora, Colorado, United States, 80045
4
Colorado Retina Associates
Lakewood, Colorado, United States, 80228