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

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...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2020-10, Vol.21 (1), p.887-887, Article 887
Main Authors: Acharya, Nisha R, Ebert, Caleb D, Kelly, Nicole K, Porco, Travis C, Ramanan, Athimalaipet V, Arnold, Benjamin F
Format: Article
Language:English
Subjects:
Adalimumab
Arthritis
Biological products
Clinical trials
Complications and side effects
Drug dosages
Drug therapy
Inflammation
Juvenile idiopathic arthritis
Juvenile rheumatoid arthritis
Monoclonal antibodies
Ophthalmology
Pediatric research
Pediatrics
Randomised controlled trial
Rheumatology
Steroids
Study Protocol
Testing
TNF inhibitors
Tuberculosis
Tumor necrosis factor-TNF
Uveitis
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Summary: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. 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
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-020-04796-z