Revision of ACR Classification Criteria for SLE

描述(由申请人提供)： 目前美国风湿病学会(ACR)对系统性红斑狼疮(SLE)的分类标准已被证明在当前的研究环境下是不合适的。在人们对系统性红斑狼疮临床试验热情高涨的时候，赞助商和研究人员都对当前的标准提出了担忧，这些标准上一次正式修订是在1983年(经过微小的修改，从未得到验证，是在1989年)。目前的标准过多地代表了皮肤狼疮，有4个标准(而其他器官只有1个)。目前的标准需要更新，以反映血清学测试(例如补体成分、新的自身抗体)、改进的诊断和实验室测试(例如肾活检结果、尿蛋白与肌酐的比率)以及器官受累的更广泛定义(例如，将神经受累重新定义为不仅仅是“癫痫”或“精神病”)方面的进展。 系统性红斑狼疮国际协作诊所(SLICC)在开发和验证SLE临床试验措施方面为合作和生产力设定了标准，包括SLE疾病活动指数(SLDEAI)、SLICC损害指数(后来也被ACR采用)和SF-36。SLICC在全球拥有近30个学术中心。在这项研究中，SLICC将：1)通过频率分析确定建议的分类标准的可行性；2)按顺序将SLE患者和有相关疾病的患者纳入系统方案，以使用传统和分类树方法测试建议的分类标准；以及3)在新的一组患者中参与验证生成的分类标准。该项目将导致更新的、经过验证的SLE分类标准，该标准可立即用于行业和学术临床试验。

DESCRIPTION (provided by applicant): The current American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE) have proven to be inadequate in the current research climate. In a time of great enthusiasm for clinical trials in SLE, both sponsors and investigators have raised concerns about the current criteria, which were officially last revised in 1983 (with minor modifications, never validated, in 1989). The current criteria over-represent cutaneous lupus, with 4 criteria (whereas every other organ receives only 1). The current criteria need to be updated to represent advances in serologic testing (e.g., complement components, new autoantibodies), improved diagnostic and laboratory testing (e.g., renal biopsy findings, urine protein to creatinine ratios) and broader definitions of organ involvement (e.g., redefining neurologic involvement as more than "seizures" or "psychosis"). The Systemic Lupus International Collaborating Clinics (SLICC) has set a standard for cooperation and productivity in the development and validation of clinical trial measures for SLE, including the SLE Disease Activity Index (SLDEAI), the SLICC Damage Index (later also adopted by the ACR), and the SF-36. SLICC consists of nearly 30 academic centers worldwide. In this study, SLICC will: 1) identify, by frequency analysis, the feasibility of proposed classification criteria; 2) sequentially enroll SLE patients and those with related diseases into a systematic protocol to test proposed classification criteria using traditional and classification tree methodology; and 3) participate in a validation exercise of the generated classification criteria in a new set of patients. This project will lead to updated, validated SLE classification criteria that can be immediately used by both industry and academic clinical trials.