Adalimumab in JIA-associated Uveitis Stopping Trial
- Conditions
- UveitisJIA
- Interventions
- Biological: AdalimumabOther: Placebo
- Registration Number
- NCT03816397
- Lead Sponsor
- Nisha Acharya
- 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 with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).
- 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 have systemic manifestations of disease but presents similarly in the eye and can result in identical visual complications as JIA-associated uveitis. Adalimumab, a tumor necrosis factor (TNF) inhibitor, effectively controls joint and eye inflammation; however, its long-term use may increase the risk of adverse health outcomes and place an undue financial burden on the patient and healthcare system given its high cost. There is great interest for patients to stop adalimumab following remission due to these reasons but there is a lack of information on the ability to maintain control after discontinuing adalimumab.
Methods: The Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Trial (ADJUST) is a multi-center international trial that will randomize 118 participants aged 2 years and older with controlled JIA-associated uveitis or chronic anterior uveitis to either continue adalimumab or discontinue adalimumab and receive a placebo. The trial will compare the time to uveitis recurrence between the two groups over 12 months. All participants will receive the standard weight-based dose of adalimumab or placebo: 20 mg biweekly (if \< 30 kg) or 40 mg biweekly (if ≥ 30 kg).
Impact: This is the first randomized controlled trial to assess the efficacy of discontinuing adalimumab after demonstrating control of JIA-associated uveitis for at least 12 months. The results of ADJUST will provide information on clinical outcomes to guide clinicians in their decision-making regarding discontinuation of adalimumab.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continue adalimumab Adalimumab Patients randomized to this arm will continue adalimumab at their current dose (either 20mg/0.2mL or 40mg/0.4mL) administered subcutaneously every other week. Stop adalimumab Placebo Patients randomized to this arm will receive a volume-matched placebo (0.8mL) administered subcutaneously every other week. Continue adalimumab Adalimumab Patients randomized to this arm will continue adalimumab at their current weight-based dose administered subcutaneously every other week. Stop adalimumab Placebo Patients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week.
- Primary Outcome Measures
Name Time Method Time to Treatment Failure From baseline until 48 weeks post-randomization Treatment failure is defined by recurrence of ocular inflammation in at least one eye as follows:
* 3+ anterior chamber (AC) for a single visit
•\>0.5+ anterior chamber (AC) cell for ≥28 days
* 2-step increase in AC cell observed at two separate visits ≥7 days apart
* 0.5+ vitreous haze, active retinal or choroidal inflammation, or macular edema observed at a single visit. Treatment failure can also be declared by recurrence of joint inflammation that is persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.
Time (days) from all participants is included in the analysis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom
Great North Children's Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Great Ormond Street Hospital
🇬🇧London, United Kingdom
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
University Hospitals Bristol and Weston
🇬🇧Bristol, United Kingdom
Cambridge University Hospital
🇬🇧Cambridge, United Kingdom
University Hospitals, Leicester
🇬🇧Leicester, United Kingdom
University of Miami
🇺🇸Miami, Florida, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Colorado Retina Associates
🇺🇸Lakewood, Colorado, United States
Murdoch Children's Research Institute
🇦🇺Parkville, Victoria, Australia
University of California, Davis
🇺🇸Sacramento, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of Texas, Austin
🇺🇸Austin, Texas, United States