Treatment of Early Aggressive Rheumatoid Arthritis TEAR

早期侵袭性类风湿性关节炎 TEAR 的治疗

• 批准号: 6439123
• 负责人: LARRY W MORELAND
• 金额: $ 10.76万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-27 至 2003-09-26
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6439123
• 关键词: acute phase protein; antiarthritic agent; arthritis therapy; chloroquine; clinical trials; combination chemotherapy; data collection methodology /evaluation; drug screening /evaluation; experimental designs; health care service planning; health services research tag; human therapy evaluation; longitudinal human study; methotrexate; patient care planning; pharmacogenetics; pharmacokinetics; rheumatoid arthritis; rheumatoid factor; sulfanilamides; synovitis; tumor necrosis factor alpha

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.

描述（由申请人提供）： 生物学毒剂和传统疾病的组合修饰 药物（DMARD）越来越多地用于RA。有效性和 但是，不同方案的副作用不可能在 制药公司进行的临床试验。提议的多中心 试验，早期攻击性类风湿关节炎（TEAR）的治疗代表 RA早期生物/DMARD组合的首次预先计划的5年试验。 因此，撕裂试验可能会为RA患者提供价值信息， 风湿病学家和食品药物管理局。拟议的试验是 3臂研究比较2种不同的组合（抗TNF加甲氨蝶呤 与甲氨蝶呤加羟基氯喹加磺胺丙嗪）与 早期RA患者的单药治疗（甲氨蝶呤），患有“侵略性” 临床表型由手工或脚部射线照相的存在定义， 或阳性血清类风湿因子，以及多个关节的主动滑膜炎。 参与RA试验的临床研究人员的指导委员会一直是 形成设计撕裂试验。需要临床试验计划补助金 对于以下具体目的：（1）进行会议和电话会议 指导委员会撰写资助撕裂审判的赠款； （2）至 开发研究材料，包括数据收集工具，设计和 准备质量控制程序，知情同意原型， 操作和程序手册（MOPP）； （3）确定确定的承诺 用于制药公司和临床研究网站的参与； （4）设计适当的药物遗传学研究 确定在此具有明显阳性临床反应的患者 审判; （6）对现有数据进行初步分析以完善 在这项临床试验中使用的结果。