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.
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.
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在受控少年性特发性关节炎相关的葡萄膜炎的患者中停止使用adalimimab（少年特发性关节炎相关的葡萄膜炎停止试验中的调节型氨基肌）：一项随机对照试验的研究方案。
DOI：
10.1186/s13063-020-04796-z
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发表时间：
2020-10-27
期刊：
影响因子：
2.5
通讯作者：
ADJUST Research Group
中科院分区：
文献类型：
--
作者：
Acharya NR;Ebert CD;Kelly NK;Porco TC;Ramanan AV;Arnold BF;ADJUST Research Group
幼年特发性关节炎（JIA）相关性葡萄膜炎是一种可导致视力损害的慢性儿科眼部炎症性疾病。阿达木单抗是一种肿瘤坏死因子（TNF）-α抑制剂，可有效控制关节和眼部炎症;然而，长期使用阿达木单抗可能会增加不良健康结局的风险，并因其高昂的成本而给患者和医疗保健系统带来不必要的经济负担。由于这些原因，患者在缓解后停用阿达木单抗的兴趣很大，但缺乏关于停用阿达木单抗后维持控制能力的信息。阿达木单抗治疗青少年特发性关节炎相关葡萄膜炎试验（ADJUST）是一项多中心、国际性试验，将118例年龄≥ 2岁的JIA相关葡萄膜炎受试者随机分配至继续阿达木单抗治疗或停用阿达木单抗并接受安慰剂治疗。该试验将比较两组在12个月内葡萄膜炎复发的时间。所有受试者将接受阿达木单抗或安慰剂的标准体重剂量：20 mg每两周一次（如果< 30 kg）或40 mg每两周一次（如果≥ 30 kg）。这是第一项评估在证实JIA相关葡萄膜炎控制至少12个月后停用阿达木单抗的疗效的随机对照试验。ADJUST的结果将提供临床结局信息，以指导临床医生做出关于停用阿达木单抗的决策。ClinicalTrials.gov NCT03816397.于2019年1月25日注册。EudraCT 2019-000412-29。于2019年1月17日注册
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 < 30 kg) or 40 mg biweekly (if ≥ 30 kg). 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. ClinicalTrials.gov NCT03816397. Registered on 25 January 2019. EudraCT 2019-000412-29. Registered on 17 January 2019
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影响因子：
27.4
作者：
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通讯作者：
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