Revision of ACR Classification Criteria for SLE

描述（由申请人提供）： 目前的美国流变学学会（ACR）系统性红斑狼疮（SLE）的分类标准已被证明是不够的，在目前的研究气候。在对SLE临床试验充满热情的时期，申办者和研究者都对现行标准提出了担忧，该标准最后一次正式修订是在1983年（1989年进行了微小修改，从未经过验证）。目前的标准过度代表皮肤狼疮，有4个标准（而其他器官只接受1个）。目前的标准需要更新，以代表血清学检测的进展（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，肾活组织检查结果，尿蛋白与肌酸酐的比率）和器官受累的更广泛定义（例如，将神经系统受累重新定义为不仅仅是“癫痫发作”或“精神病”）。 系统性狼疮国际合作诊所（SLICC）为SLE临床试验指标的开发和验证制定了合作和生产力标准，包括SLE疾病活动指数（SLDEAI），SLICC损伤指数（后来也被ACR采用）和SF-36。SLICC由全球近30个学术中心组成。在本研究中，SLICC将：1）通过频率分析，识别所提出的分类标准的可行性; 2）将SLE患者和具有相关疾病的患者顺序地登记到系统方案中，以使用传统方法和分类树方法来测试所提出的分类标准;以及3）在新的患者集合中参与所生成的分类标准的验证练习。该项目将导致更新的，有效的SLE分类标准，可以立即用于工业和学术临床试验。

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.