Discontinuing adalimumab in patients with controlled juvenile idiopathic arthritis-associated uveitis (ADJUST—Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial): study protocol for a randomised controlled trial
Author:
Acharya Nisha R.ORCID, Ebert Caleb D., Kelly Nicole K., Porco Travis C., Ramanan Athimalaipet V., Arnold Benjamin F., Acharya Nisha R., Porco Travis C., Arnold Benjamin F., Doan Thuy, Gonzales John A., von Scheven Emily, Angeles-Han Shelia T., Miraldi Utz Virginia, Vitale Albert T., Hersh Aimee O., Overbury Rebecca S., Stahl Erin D., Cooper Ashley M., Lerman Melissa A., Davidson Stefanie L., Thorne Jennifer E., Ogbu Ekemini A., Nanda Kabita, Herlihy Erin P., Cabrera Michelle T., Dacey Mark S., Moore Katharine F., Guly Catherine, Dick Andrew D., Petrushkin Harry, Moraitis Elena, Solebo Ameenat L., Cleary Gavin, Gonzalez-Martin Jose A., Jandial Sharmila, Clarke Michael P., May Kristina, Leahy Alice, Choi Jessy, Hawley Daniel, Puvanachandra Narman, Armon Kate, Renton William D., Troutbeck Robyn,
Abstract
Abstract
Background
Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic paediatric ocular inflammatory condition that can result in visual impairment. Adalimumab, a tumour necrosis factor (TNF)-alpha 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 multicentred, international trial that will randomise 118 participants aged 2 years and older with controlled JIA-associated 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).
Discussion
This is the first randomised 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.
Trial registration
ClinicalTrials.gov NCT03816397. Registered on 25 January 2019. EudraCT 2019-000412-29. Registered on 17 January 2019
Funder
National Eye Institute
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference34 articles.
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