Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Trial (ADJUST) - Diversity Supplement

阿达木单抗在幼年特发性关节炎相关葡萄膜炎试验 (ADJUST) 中的应用 - 多样性补充

• 批准号: 10673550
• 负责人: NISHA ACHARYA
• 金额: $ 7.26万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10673550
• 关键词: Address; Adverse event; Age; Anterior uveitis; Antibodies; Antimetabolites; Arthritis; Back; Benefits and Risks; C-reactive protein; Characteristics; Child; Chronic; Chronic Childhood Arthritis; Clinical; Clinical Trials; Data; Data Analyses; Data Set; Development; Diagnosis; Disease; Drug resistance; Economics; Erythrocyte Sedimentation Rate; Flare; Funding; Healthcare Systems; Immune; Incidence; Inflammation; Injections; International; Learning; Length; Leukocyte L1 Antigen Complex; Masks; Measures; Mediating; Medical Students; National Health Services; Ophthalmology; Opportunistic Infections; Outcome; Patients; Pharmaceutical Preparations; Placebos; Policies; Predictive Factor; Quality of life; Randomized; Randomized Controlled Trials; Recurrence; Reiter Disease; Research; Risk; S100A8 gene; Safety; Scientist; Serum; Steroids; Time; Treatment Failure; Treatment Protocols; Uveitis; Uveomeningoencephalitic Syndrome; Visit; Visual; Visual Acuity; Weighing patient; Withdrawal; adalimumab; career development; data management; design; effective therapy; evidence based guidelines; experience; legally blind; patient population; primary outcome; randomized placebo controlled trial; secondary outcome; subcutaneous; treatment adherence; treatment comparison; treatment duration; treatment group; treatment strategy; tumor necrosis factor-alpha inhibitor

PROJECT SUMMARY Up to one-third of all patients with juvenile idiopathic arthritis (JIA) develop chronic, asymptomatic, anterior uveitis within 4 to 7 years of their arthritis onset. Patients with JIA-associated uveitis often have poor long-term visual outcomes, including nearly 10 to 15% of patients becoming legally blind. Adalimumab, a TNF-alpha inhibitor, has been demonstrated to be an effective treatment for juvenile idiopathic arthritis-associate (JIA) uveitis, but there is no evidence-based guidelines for the optimal duration of treatment. There are safety concerns with long-term adalimumab treatment as TNF-alpha inhibitors are associated with an increased risk of opportunistic infections and development of immune-mediated resistance to drug. Adalimumab is also expensive for patients and the healthcare systems. The National Health Service in the UK has implemented a policy to withdraw adalimumab from children who respond well to the treatment because of economic reasons, yet there is no scientific evidence to back up this policy of mandatory withdrawal. The ADalimumab in Juvenile Idiopathic Arthritis (JIA)-associated Uveitis Stopping Trial (ADJUST) is a randomized controlled trial to examine uveitis recurrence rates between patients who discontinue adalimumab treatment compared to patients who continue treatment with the following aims: (1) In patients with controlled JIA-associated uveitis, to compare rate of recurrence and time to recurrence of ocular inflammation in patients randomized to discontinue adalimumab compared to those who continue treatment, (2) To determine predictors of JIA-associated uveitis disease recurrence, and (3) To determine if stopping adalimumab leads to overall less control of inflammation at the 12-month visit, even if patients restart adalimumab after a uveitis recurrence. This study will provide an evidence base for guidelines on the risks and benefits of withdrawing adalimumab in patients with JIA-associated uveitis. This proposed diversity supplement will support our candidate in learning how to manage international clinical trials in ophthalmology and gain first-hand experience in data management and analysis by working on ADJUST and other established datasets.

项目总结

项目成果

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.

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
• 发表时间: 2020-10-27
• 期刊: Trials
• 影响因子: 2.5
• 作者: Acharya NR;Ebert CD;Kelly NK;Porco TC;Ramanan AV;Arnold BF;ADJUST Research Group
• 通讯作者: ADJUST Research Group