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
| Autor: | Ameenat Solebo, Sheila Angeles-Han, Nicole K. Kelly, Nisha Acharya, Rebecca Overbury, Erin Herlihy, Andrew Dick |
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| Rok vydání: | 2020 |
| Předmět: |
Medicine (miscellaneous)
Arthritis Juvenile Cardiorespiratory Medicine and Haematology Eye law.invention Study Protocol 0302 clinical medicine Randomized controlled trial law Pharmacology (medical) skin and connective tissue diseases Child Randomized Controlled Trials as Topic Randomised controlled trial Pediatric lcsh:R5-920 Treatment Outcome Antirheumatic Agents 6.1 Pharmaceuticals medicine.symptom lcsh:Medicine (General) Uveitis medicine.drug musculoskeletal diseases medicine.medical_specialty Visual impairment Clinical Trials and Supportive Activities Clinical Sciences Placebo Autoimmune Disease 03 medical and health sciences Rare Diseases Clinical Research Internal medicine General & Internal Medicine Adalimumab medicine Humans Eye Disease and Disorders of Vision 030203 arthritis & rheumatology business.industry Inflammatory and immune system Evaluation of treatments and therapeutic interventions Juvenile idiopathic arthritis medicine.disease Arthritis Juvenile Discontinuation ADJUST Research Group Cardiovascular System & Hematology Chronic Disease 030221 ophthalmology & optometry business |
| Zdroj: | Trials, vol 21, iss 1 Trials, Vol 21, Iss 1, Pp 1-12 (2020) Trials |
| ISSN: | 0381-6397 |
| Popis: | 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 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 |
| Databáze: | OpenAIRE |
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