ANTI TNF CHIMERIC MONOCLONAL ANTIBODY IN PATIENTS WITH RHEUMATOID ARTHRITIS

类风湿性关节炎患者的抗 TNF 嵌合单克隆抗体

• 批准号: 6274548
• 负责人: JOAN M VON FELDT
• 金额: $ 2.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-15 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274548
• 关键词: chimeric proteins; clinical research; clinical trials; human subject; human therapy evaluation; immunotherapy; monoclonal antibody; rheumatoid arthritis; tumor necrosis factor alpha

Current therapy for Rheumatiod arthritis comprises non-steroidal anti- inflammatory drugs (NSAIDs) in early stages of the disease, ultimately given way to oral steroids and the disease-modifying anti-rheumatic drugs (DMARDs) as the disease progressively worsens. Methotrexate (MTX) has become the DMARD of choice of many rheumatologists because of its faster mode of action and better record of prolonged use. However, despite the use of high doses of MTX, many patients only experience partial relief of symptoms and still have features of active disease. Experimental evidence implicates TNF as an important mediator in the pathobiology of RA and underscores TNF as an appropriate therapeutic target. Chimeric A2 (cA2) is a monoclonal antibody that binds with high affinity and specificity to human TNF and neutralizes its biologic activity. The current trial is designed to show in a larger patient population (n=300) that cA2 given for up to one year will provide a rapid and sustained reduction of clinical signs and symptoms of RA in patients who have active RA despite MTX therapy. Four cA2 treatment groups will be evaluated and compared to a placebo group. The primary endpoint in this study will be a reduction in the clinical signs and symptoms of RA at 30 weeks following the onset of treatment. Continuing reduction in signs and symptoms, as well as disability, joint damage, disease remission and quality of life will be evaluated at 1 year.

类风湿性关节炎的当前疗法包括非甾体类抗- 炎症药物（NSAID）在疾病的早期阶段，最终 口服类固醇和缓解疾病的抗风湿药 药物（DMARDs）随着疾病的进展而增加。 甲氨蝶呤（MTX） 已成为许多风湿病学家的选择，因为它 更快的作用模式和更好的长期使用记录。 然而，在这方面， 尽管使用了高剂量的MTX，但许多患者只经历了 症状部分缓解，但仍具有活动性疾病的特征。 实验证据表明TNF作为一种重要的介质， RA的病理生物学，并强调TNF作为适当的治疗药物 目标嵌合A2（cA 2）是一种单克隆抗体， 对人TNF的亲和力和特异性，并中和其生物活性 活动 目前的试验旨在在更大的患者人群中显示 （n=300）给予长达一年的cA 2将提供快速和 持续减少RA患者的临床体征和症状， MTX治疗后仍有活动性RA。 4个cA 2治疗组将 评估并与安慰剂组进行比较。 本研究的主要终点 研究将减少RA的临床体征和症状， 治疗开始后30周。 继续减少 体征和症状，以及残疾、关节损伤、疾病 将在1年时评价缓解和生活质量。