Zhao Jinjun, Zhan Taihe, Zhu Junqing, Fan Meida, Huang Qin, Ren Hao, Wu Jing, Yu Qinghong, Lin Jingli, Ouyang Qingqing, An Shengli, Yang Min
Department of Rheumatology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Department of Rheumatology and Clinical Immunology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
BMJ Open. 2018 Nov 15;8(11):e023798. doi: 10.1136/bmjopen-2018-023798.
Rheumatoid arthritis (RA) is a chronic systemic disease and one of the most disabling diseases for patients. The American College of Rheumatology (ACR) issued a new guideline in 2015 for the treatment of RA based on the treat-to-target strategy to achieve better outcomes. This study will focus on the real-world rates of remission and low disease activity of patients with early RA in China, who will be treated according to the 2015 ACR guideline. Additionally, factors influencing treat-to-target outcomes will be analysed, and long-term prognosis and quality of life will be assessed.
Two-hundred patients with early RA will be enrolled, treated and followed up once every 3 months for 48 months. These patients should fulfil the 2010 RA classification criteria of the ACR/European League Against Rheumatism with a disease course of no more than 6 months and should also fulfil other eligibility criteria. The patients will be treated following the 2015 ACR guideline. Their disease activity will be assessed, and they will be instructed to complete several questionnaires once every 3 months. The primary outcomes are the Disease Activity Score on 28 joints and Health Assessment Questionnaire Disability Index. The secondary outcome variables are the Simplified Disease Activity Index, Clinical Disease Activity Index and Routine Assessment of Patient Index Data 3 results, imaging data and personal medical costs. The data will be analysed using appropriate statistical analyses.
This research was approved by the Nanfang Hospital Ethics Committee (NFEC-2017-192). The results of the study will be published in international peer-reviewed journals.
NCT03508713; Pre-results.
类风湿关节炎（RA）是一种慢性全身性疾病，也是对患者致残性最强的疾病之一。美国风湿病学会（ACR）于2015年发布了一项基于治疗达标策略的RA治疗新指南，以实现更好的治疗效果。本研究将聚焦于中国早期RA患者的实际缓解率和低疾病活动率，这些患者将按照2015年ACR指南进行治疗。此外，还将分析影响治疗达标结果的因素，并评估长期预后和生活质量。
将招募200例早期RA患者，每3个月进行一次治疗和随访，为期48个月。这些患者应符合2010年ACR/欧洲抗风湿病联盟的RA分类标准，病程不超过6个月，且还应符合其他入选标准。患者将按照2015年ACR指南进行治疗。将评估他们的疾病活动情况，并指导他们每3个月完成几份问卷。主要结局指标为28个关节疾病活动评分和健康评估问卷残疾指数。次要结局变量为简化疾病活动指数、临床疾病活动指数和患者指数数据3常规评估结果、影像学数据及个人医疗费用。将使用适当的统计分析方法对数据进行分析。
本研究已获得南方医院伦理委员会批准（NFEC-2017-192）。研究结果将发表在国际同行评审期刊上。
NCT03508713；预结果。
