Behcet

贝赫切特

• 批准号: 6432482
• 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/6432482
• 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 Behcet's 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 Behcet's 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. This study continues to actively recruit patients. The results are monitored by the NEI Data and Safety Monitoring Committee. Since it is an ongoing masked study, there are no results to report.

这是一项Zenapax（一种人源化抗Tac抗体）与安慰剂联合标准疗法治疗白塞氏病眼部并发症的随机盲法初步试验。本研究的主要目的是研究赛尼哌在控制白塞氏病患者眼部表现的复发性爆发性方面的安全性和有效性。将随机分配20名患者。该研究的主要疗效结果基于2年研究期间经历的眼部发作次数和免疫抑制药物的量。次要疗效结局包括炎症水平。本研究继续积极招募患者。结果由NEI数据和安全监测委员会监测。由于这是一项正在进行的设盲研究，因此无结果可报告。