Treat to Target to Reduce Atherosclerosis in Rheumatoid Arthritis

治疗以减少类风湿性关节炎的动脉粥样硬化为目标

• 批准号: 8435756
• 负责人: Joan Marie Bathon
• 金额: $ 36.93万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8435756
• 关键词: Advocate; Affect; Age; Algorithms; Atherosclerosis; Blood Vessels; Cardiovascular Diseases; Cause of Death; Clinical; Clinical Management; Clinical Trials Design; Conflict (Psychology); DNA; Data; Disease; Disease Outcome; Disease-Modifying Second-Line Drugs; Dose; Elderly; Ensure; Epidemiologic Studies; Event; Funding; Gender; General Population; Goals; Grant; Hospitals; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Image; Immunosuppression; Immunosuppressive Agents; Inflammation; Inflammatory; Information Management; Institutional Review Boards; Insulin Resistance; Intervention; Investigation; Joints; Laboratories; Lead; Lipids; Low-Density Lipoproteins; Manuals; Measurement; Measures; Methods; Observational Study; Outcome; Outcome Assessment; Outcome Measure; Pain; Participant; Patients; Pharmaceutical Preparations; Plasma; Procedures; Protocols documentation; Provider; Randomized; Randomized Controlled Trials; Reading; Recruitment Activity; Research Personnel; Rheumatoid Arthritis; Risk; Risk Factors; Safety; Sample Size; Signs and Symptoms; Site; Swelling; TNF gene; Testing; Thick; Time; Training; Translating; Woman; Workplace; arm; base; biobank; cardiovascular disorder risk; design; evidence base; experience; follow-up; improved; interest; intima media; middle age; primary outcome; public health relevance; rheumatologist; secondary outcome; treatment as usual; treatment effect; treatment strategy; trend

DESCRIPTION (provided by applicant): Multiple epidemiologic studies have demonstrated an increased risk of cardiovascular disease (CVD) in rheumatoid arthritis (RA); it is the number one cause of death in RA. The elevated inflammatory burden of RA is postulated to contribute to this risk, supported by a number of observational studies supporting the benefits of aggressive immunosuppression on CVD risk. However, there are conflicting findings among the observational studies regarding the effect of treatment on CVD risk, and, importantly, none provides a sufficient evidence-base to inform providers how to manage this risk. Currently, there is general enthusiasm regarding Treat to Target (TTT) in RA for managing articular signs and symptoms. However, there are no data whether TTT may improve non-articular outcomes, such as atherosclerosis. This proposal describes the rationale and design of a randomized controlled trial testing the effects of TTT versus usual care on the progression of carotid thickness (IMT) and other secondary measures of atherosclerosis progression. We request 24 months of funding to further plan this trial. The planning period will entail many activities, including selecting a core vascular laboratory, determining the best imaging protocol, developing training materials for the imaging, finalizing trial design and procedures, developing a Manual of Operating Procedures, and site recruitment/selection. We anticipate submission of a trial proposal early during year 2 and then continuing with IRB work, site subcontracting, and creating trial materials. This will allow us to be ready to recruit early in the trial period. Thetrial will be the first of its kind in RA and will provide important clinical information for the management of CV risk in RA patients.

描述（由申请人提供）：多种流行病学研究表明，类风湿关节炎（RA）患心血管疾病（CVD）的风险增加。这是RA中死亡的第一大原因。 RA的炎症负担升高被认为会导致这种风险，并得到了许多观察性研究的支持，这些研究支持了CVD风险的积极免疫抑制的益处。但是，关于治疗对CVD风险的影响的观察性研究之间存在矛盾的发现，重要的是，没有一个提供足够的证据基础来告知提供者如何管理这种风险。当前，在RA中，对靶标（TTT）的治疗症状和症状都有普遍的热情。但是，没有数据是否可以改善非关节结局，例如动脉粥样硬化。 该提案描述了一项随机对照试验的理由和设计，该试验测试了TTT与常规护理对颈动脉厚度（IMT）进展的影响以及动脉粥样硬化进展的其他次要测量。我们要求24个月的资金进一步计划这项审判。计划期将需要许多活动，包括选择核心血管实验室，确定最佳成像协议，为成像开发培训材料，完成试验设计和程序，制定操作程序手册以及现场招聘/选择。我们预计在第二年初提交了一项试验建议，然后继续进行IRB工作，现场分包和创建试用材料。这将使我们准备在试用期早期招募。 多元将是RA中的第一个同类产品，将为RA患者的CV风险管理提供重要的临床信息。