TEAR

眼泪

• 批准号: 7380448
• 负责人: LARRY W MORELAND
• 金额: $ 0.68万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380448
• 关键词: TEAR

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A steering committee of clinical researchers involved with rheumatoid arthritis (RA) trials was formed to design the Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) trial as part of an NIH-Funded Clinical Trails Planning Grant (R21AR48343, PI, Moreland). The multicenter TEAR trial represents the first 2-year trial to prospectively analyze the long-term outcomes of treatment of early, "aggressive" RA with combinations of currently Food and Drug Administration (FDA) approved biologic agents and traditional disease-modifying anti-rheumatic drugs (DMARDs). TEAR is an investigator-initiated trial utilizing available FDA approved medications; the over riding goal of this study is to help establish appropriate standard of care for patients with early "aggressive" RA. The TEAR trial design is a 2x2 factorial design comparing 2 different combinations (the tumor necrosis factor [TNF] antagonist etanercept, plus methotrexate [MTW] versus MTX plus hydroxychloroquine [HCQ] plus sulfasalazine [SSZ] in patients with early RA who have an "aggressive" clinical phenotype defined by presence of active synovitis of multiple joints. The results will provide novel information on the best treatment approach for patients with early RA.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。参与类风湿性关节炎（RA）试验的临床研究人员组成了一个指导委员会，以设计早期侵袭性类风湿性关节炎（TEAR）试验的治疗，作为NIH资助的临床试验计划资助（R21 AR 48343，PI，莫兰）的一部分。多中心TEAR试验代表了第一项为期2年的试验，前瞻性分析了目前美国食品药品监督管理局（FDA）批准的生物制剂和传统疾病缓解抗风湿药物（DMARD）联合治疗早期“侵袭性”RA的长期结局。TEAR是一项利用FDA批准的药物进行的临床试验;本研究的首要目标是帮助早期“侵袭性”RA患者建立适当的护理标准。TEAR试验设计为2 × 2析因设计，比较2种不同组合（肿瘤坏死因子[TNF]拮抗剂依那西普+甲氨蝶呤[MTW]与MTX+羟氯喹[HCQ]+柳氮磺胺吡啶[SSZ]）在具有“侵袭性”临床表型（定义为存在多个关节的活动性滑膜炎）的早期RA患者中的疗效。这些结果将为早期RA患者的最佳治疗方法提供新的信息。