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Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial

阿达木单抗在幼年特发性关节炎相关葡萄膜炎中的停止试验

基本信息

批准号：
9920146
负责人：
NISHA ACHARYA
金额：
$ 131.19万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
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/9920146
关键词：
16 year old Address Adverse event Age Anterior uveitis Antibodies Arthritis Autoimmune Diseases Benefits and Risks Biological Biological Markers Biological Response Modifier Therapy C-reactive protein Cataract Characteristics Child Childhood Chronic Chronic Childhood Arthritis Clinical Data Decision Making Disease Disease remission Disease-Modifying Second-Line Drugs Erythrocyte Sedimentation Rate Etiology Evidence based treatment Financial Hardship Flare Glaucoma Healthcare Systems Inflammation Inflammatory Keratopathy Lead Malignant Neoplasms Masks Methotrexate Morbidity - disease rate Ophthalmologist Opportunistic Infections Outcome Pathology Patients Persons Pharmaceutical Preparations Practice Management Randomized Randomized Clinical Trials Randomized Controlled Trials Recurrence Refractory Relapse Retreatment Risk Rogaine S100A8 gene Safety Secondary to Serious Adverse Event Serum TNF gene Time Treatment Failure Uveitis Visit Visual impairment Withdrawal Withdrawing Treatments adalimumab adverse event risk clinical practice clinically relevant disorder control drug withdrawal evidence based guidelines human monoclonal antibodies inhibitor/antagonist interest legally blind macula potential biomarker relapse prediction response rheumatologist treatment arm treatment duration tumor necrosis factor-alpha inhibitor

项目摘要

PROJECT SUMMARY/ABSTRACT Juvenile idiopathic arthritis (JIA) is the most common rheumatologic condition in children, and 12- 38% of patients with JIA develop chronic asymptomatic anterior uveitis, typically within 4 to 7 years of arthritis onset. JIA-associated uveitis can cause significant morbidity, with as many as 1/3 of all patients developing substantial visual impairment and up to 15% becoming legally blind. The anti-TNF-α human monoclonal antibody adalimumab has shown efficacy in treating JIA- associated uveitis, but is associated with a risk of serious adverse events, including opportunistic infections and malignancy. Furthermore, long-term treatment with adalimumab is expensive and causes significant financial burden for the patient and healthcare system. However, stopping adalimumab may come with risks of its own; it has been shown that stopping and restarting anti- TNF-α therapy in patients with other autoimmune diseases is associated with reduced responsiveness to the drug. Collectively, these reasons contribute to a growing interest in developing evidence-based guidelines for stopping adalimumab treatment once control of inflammation has been achieved. We propose a multicenter, double-masked, randomized controlled trial to address clinically relevant questions about stopping adalimumab in patients with controlled JIA-associated uveitis. In patients with controlled JIA-associated uveitis, we will compare rate of recurrence and time to recurrence of ocular inflammation in patients randomized to discontinue adalimumab compared to those who continue treatment (Aim 1). We will also evaluate key predictors of JIA-associated uveitis recurrence by assessing clinical characteristics and potential biomarkers associated with recurrence of uveitis (Aim 2). Finally, we will determine if stopping adalimumab leads to overall less control of inflammation at the 6 and 12-month visits, even if patients restart adalimumab after a uveitis recurrence (Aim 3). By following patients from randomization to potential relapse and re- treatment, we can better understand the consequences of stopping and restarting adalimumab. With the increasing use of TNF-α inhibitors, understanding the risks and benefits of stopping adalimumab in patients with controlled JIA-associated uveitis is important to inform clinical practice for management of these patients. This study could also identify predictors of relapse and drug response that would be useful in making evidence-based treatment decisions. !

项目总结/文摘