Treatment of Early Aggressive Rheumatoid Arthritis TEAR

描述（由申请人提供）： 生物制剂与传统疾病缓解抗风湿药的联合应用 药物（DMARDs）越来越多地用于早期RA。的有效性和 然而，不同治疗方案的副作用不太可能比较， 制药公司进行的临床试验。拟定的多中心 试验，早期侵袭性风湿性关节炎（TEAR）的治疗，代表了 第一个预先计划的5年生物/DMARD联合治疗早期RA的试验。 因此，TEAR试验可能为RA患者提供有价值的信息， 风湿病学家和食品药品监督管理局。拟议的审判是一个 3-比较2种不同组合（抗TNF+甲氨蝶呤）的组研究 与甲氨蝶呤+羟氯喹+柳氮磺胺吡啶相比）与 单药治疗（甲氨蝶呤）在具有“侵袭性” 临床表型定义为手或脚X线片上存在糜烂， 或血清类风湿因子阳性，伴多关节活动性滑膜炎。 参与RA试验的临床研究人员指导委员会已经 设计了TEAR试验。需要临床试验计划补助金 具体目的如下：（1）召开会议和电话会议 （2）在第（1）款所指的情况下， 开发研究材料，包括数据收集工具、设计和 编制质量控制程序、知情同意书原型， 操作和程序手册（MOPP）;（3）确保明确的承诺 供制药公司和临床研究机构参与; (4)设计适当的药物遗传学研究， 确定在这方面具有显著阳性临床应答的患者 试验;（6）对现有数据进行初步分析， 本临床试验中使用的结果。

DESCRIPTION (provided by applicant): Combinations of biologic agents and traditional disease modifying antirheumatic drugs (DMARDs) are being increasingly used in early RA. The effectiveness and side effects of different regimens, however, are unlikely to be compared in clinical trials performed by pharmaceutical companies. The proposed multicenter trial, Treatment of Early Aggressive Rheumatoid Arthritis (TEAR), represents the first pre-planned 5-year trial of biologic/DMARD combinations in early RA. Thus, the TEAR trial might provide information of value to RA patients, rheurnatologists and the Food & Drug Administration. The proposed trial is a 3-arm study comparing 2 different combinations (anti-TNF plus methotrexate versus methotrexate plus hydroxychloroquine plus sulfasalazine) versus monotherapy (methotrexate) in patients with early RA who have an "aggressive" clinical phenotype defined by presence of erosions on hand or feet radiographs, or positive serum rheumatoid factor, plus active synovitis of multiple joints. A steering committee of clinical researchers involved with RA trials has been formed to design the TEAR trial. The clinical trials planning grant is needed for the following specific aims: (1) to conduct meetings and conference calls of steering committee to write the grant for funding of the TEAR trial; (2) to develop study materials including data collection instruments, design and preparation for the quality control procedures, informed consent prototype, manual of operations and procedures (MOPP); (3) to secure definite commitments for participation from pharmaceutical companies and clinical research sites; (4) to design appropriate pharmacogenetic studies that potentially would identify patients who have a significant positive clinical response in this trial; and (6) to perform preliminary analysis of existing data to refine the outcomes to be used in this clinical trial.