ANTI TNF CHIMERIC MONOCLONAL ANTIBODY IN PATIENTS WITH RHEUMATOID ARTHRITIS

类风湿性关节炎的当前疗法包括在疾病的早期阶段的非甾体抗炎药（NSAID），随着疾病的进展，最终让位于口服类固醇和疾病缓解抗风湿药（DMARD）。 甲氨蝶呤（MTX）已成为许多风湿病学家选择的DMARD，因为它的作用方式更快，长期使用的记录更好。 然而，尽管使用高剂量的MTX，许多患者仅经历症状的部分缓解，并且仍然具有活动性疾病的特征。实验证据表明TNF是RA病理生物学的重要介质，并强调TNF是适当的治疗靶点。嵌合A2（cA2）是一种单克隆抗体，其以高亲和力和特异性结合人TNF并中和其生物活性。目前的试验旨在在更大的患者人群（n=300）中显示，给予长达一年的cA2将使尽管接受MTX治疗但仍患有活动性RA的患者的RA临床体征和症状迅速和持续减少。 将评价4个cA2治疗组，并与安慰剂组进行比较。 本研究的主要终点将是治疗开始后30周时RA临床体征和症状的减轻。 将在1年时评价体征和症状的持续减轻以及残疾、关节损伤、疾病缓解和生活质量。

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 reduciton 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.