Planing an Early RA Prevention Trial

规划早期 RA 预防试验

• 批准号: 6912106
• 负责人: DAVID STEPHEN PISETSKY
• 金额: $ 15.4万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-01 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6912106
• 关键词: antirheumatic agents; arthritis therapy; clinical research; clinical trials; combination chemotherapy; disease /disorder prevention /control; drug administration rate /duration; drug screening /evaluation; ethics; health care policy; health related legal; human data; informed consent; longitudinal human study; medical outreach /case finding; methotrexate; monoclonal antibody; outcomes research; patient care management; patient care planning; remission /regression; rheumatoid arthritis; statistics /biometry; synovitis; therapy design /development; tumor necrosis factor alpha

DESCRIPTION (provided by applicant): The goal of this planning grant is to complete development of a clinical trial for primary and secondary prevention of rheumatoid arthritis (RA) and to establish the infrastructure for the performance of the trial. The trial is titled RAPIDT (Rheumatoid Arthritis Prevention by Immediate Definitive Therapy) and is designed to determine the impact of DMARD therapy in patients with early synovitis. The study will have 5 arms consisting of patients administered DMARD therapy (methotrexate alone or methotrexate plus infliximab) for either 3 months or 12 months, with a control arm receiving conventional therapy for 3 months. The primary outcomes will be remission at the end of treatment and remission 1 year after the cessation of therapy. As such, this trial addresses the "window of opportunity" hypothesis. It is anticipated that a grant will be submitted to the NIH for a coordinating center for this trial, with other funding obtained from industry. A planning grant is proposed at this tune to finalize trial design and develop procedures of operation as well as identify sites. Three specific aims are proposed: 1) To complete development of the protocol. This specific aim will include finalization of the trial design, refining primary and secondary outcome measures and addressing issues of statistical analysis in a trial aimed at the induction of remission; 2) To address issues of informed consent in the context of prevention strategies for RA. Since RAPIDT is designed to be a prevention study, the informed consent process will differ from other trials on RA in the past. This aim will consider issues of early treatment to construct an appropriate informed consent; and 3) To complete a manual of operations and procedures, implement approaches for data management and identify sites for performance. This aim will establish the infrastructure for the trial and provide all the essential elements to allow enrollment to begin.

描述（由申请人提供）： 该规划拨款的目标是完成类风湿性关节炎（RA）一级和二级预防的临床试验的开发，并为该试验的实施建立基础设施。 该试验名为 RAPIDT（通过立即明确治疗预防类风湿关节炎），旨在确定 DMARD 治疗对早期滑膜炎患者的影响。该研究将有 5 个组，由接受 DMARD 治疗（单独甲氨蝶呤或甲氨蝶呤加英夫利昔单抗）治疗 3 个月或 12 个月的患者组成，对照组接受 3 个月的常规治疗。主要结局是治疗结束时的缓解和治疗停止后 1 年后的缓解。因此，该试验解决了“机会之窗”假设。预计将向美国国立卫生研究院提交一笔拨款，用于该试验的协调中心，其他资金则来自工业界。此次提议提供规划拨款，以完成试验设计、制定操作程序以及确定地点。提出了三个具体目标： 1）完成协议的开发。这一具体目标将包括最终确定试验设计、完善主要和次要结局指标以及解决旨在诱导缓解的试验中的统计分析问题； 2) 解决 RA 预防策略中的知情同意问题。由于 RAPIDT 被设计为一项预防研究，因此知情同意程序将与过去其他 RA 试验不同。这一目标将考虑早期治疗问题，以建立适当的知情同意书； 3) 完成操作和程序手册，实施数据管理方法并确定绩效地点。这一目标将为试验建立基础设施，并提供开始注册所需的所有基本要素。