ANTI TNF CHIMERIC MONOCLONAL ANTIBODY IN PATIENTS WITH RHEUMATOID ARTHRITIS

目前治疗类风湿性关节炎的方法包括非类固醇抗炎药 炎症药物(NSAIDs)在疾病的早期阶段，最终 让位于口服类固醇和抗风湿病 随着疾病的逐渐恶化，药物(DMARDS)。甲氨蝶呤(MTX) 已经成为许多风湿科医生的首选DMARD，因为它 更快的行动方式和更好的长时间使用记录。然而， 尽管使用了大剂量的MTX，但许多患者只经历了 症状部分缓解，仍具有活动性疾病的特点。 实验证据表明，肿瘤坏死因子是一种重要的调节因子。 类风湿关节炎的病理生物学和强调肿瘤坏死因子是一种合适的治疗方法 目标。嵌合体A2(CA2)是一种与高亲和力结合的单抗 与人肿瘤坏死因子的亲和力和特异性及其生物学中和 活动。 目前的试验是为了在更大的患者群体中显示 (n=300)给予长达一年的CA2将提供快速和 类风湿关节炎患者的临床症状和体征持续减少 尽管接受MTX治疗，但仍有活动期的类风湿关节炎。四个CA2治疗组将 评估并与安慰剂组进行比较。此中的主端点 研究将减少类风湿性关节炎的临床症状和体征 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 缓解情况和生活质量将在1年后进行评估。

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.