TEAR

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。参与类风湿关节炎（RA）试验的临床研究人员组成指导委员会，设计早期侵袭性类风湿关节炎治疗（TEAR）试验，作为美国国立卫生研究院资助的临床试验规划拨款（R21AR48343， PI, Moreland）的一部分。多中心TEAR试验是首个为期2年的前瞻性试验，旨在分析目前美国食品和药物管理局（FDA）批准的生物制剂和传统疾病改善抗风湿药物（DMARDs）联合治疗早期“侵袭性”RA的长期结果。TEAR是一项由研究者发起的试验，利用FDA批准的现有药物；本研究的首要目标是为早期“侵袭性”类风湿性关节炎患者建立适当的护理标准。TEAR试验设计是2x2因子设计，比较两种不同的组合（肿瘤坏死因子拮抗剂依那西普加甲氨蝶呤[MTW]与MTX加羟氯喹[HCQ]加磺胺氮嗪[SSZ]）对具有“侵袭性”临床表型（多关节活动性滑膜炎）的早期RA患者的影响。该结果将为早期RA患者的最佳治疗方法提供新的信息。

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.