Anti Tac Antibody Treatment in Behcet's Disease

白塞氏病的抗 Tac 抗体治疗

• 批准号: 6227961
• 负责人: ROBERT B. NUSSENBLATT
• 金额: --
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6227961
• 关键词: Behcet's syndrome; antireceptor antibody; clinical research; cytokine receptors; drug screening /evaluation; eye disorder chemotherapy; human subject; human therapy evaluation; immunotherapy; interleukin 2; monoclonal antibody

This is a randomized masked pilot trial of Zenapax (a humanized anti- Tac antibody) vs placebo combined with standard therapy in the treatment of the ocular complications of Behcets disease. The primary goal of the study is to investigate the safety and efficacy of Zenapax in controlling the recurrent explosive nature of ocular manifestations in patients with Behcets disease. Twenty patients will be randomly assigned. The primary efficacy outcomes of the study are based on the number of ocular attacks experienced and the amount of immunosuppressive medications over the 2 year study period. Secondary efficacy outcomes include the level of inflammation. - Behcet's disease, anti-Tac antibody, uveitis, retinal vasculitis - Human Subjects

这是一项Zenapax（一种人源化抗TAC抗体）的随机掩盖试验试验，与安慰剂结合了标准疗法，以治疗Behcets病的眼部并发症。该研究的主要目的是研究Zenapax在控制Behcets疾病患者眼部表现的复发性爆炸性方面的安全性和功效。将随机分配20名患者。该研究的主要功效结果是基于在2年研究期内经历的眼部攻击数量和免疫抑制药物的量。次级功效结果包括炎症水平。 - Behcet病，抗TAC抗体，葡萄膜炎，视网膜血管炎 - 人类受试者