CHIMERIC ANTI-CD4 WITHOUT CONCOMITANT DMARD THERAPY IN RHEUMATOID ARTHRITIS

类风湿性关节炎中不伴随 DMARD 治疗的嵌合抗 CD4

• 批准号: 5215579
• 负责人: Eugene William St. Clair
• 金额: --
• 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/5215579
• 关键词: CD antigens; antiarthritic agent; clinical research; dosage; drug administration rate /duration; drug screening /evaluation; human subject; human therapy evaluation; hybrid antibody; immunotherapy; rheumatoid arthritis

The objectives of this study are to monitor all previously treated patients for long-term safety, duration of response and CD4 + T-cell count > 400/mm3. Any patient who has received treatment with chimeric Anti-CD4 will be monitored for serious adverse events, opportunistic infections, immunosuppressive and anti-infective medication history, lymphocyte recovery, and general disease status. Safety assessments are performed every 6 months until the absolute lymphocyte count (ALC) is > 400 cells/mm3 . We had five patients complete the randomized phase of the study and all patients have shown < 30 % decrease in their disease activity. All five patients received open-label chimeric Anti-CD4 treatment at the highest dose of 50 mg/day and there was no significant improvement in their disease activity. The randomized study was stopped prematurely because an interim analysis revealed no differences in efficacy between the placebo and treatment groups. We have completed the safety follow-up on all five of our patients. The study is closed.

这项研究的目标是监视所有先前治疗的 长期安全性，反应持续时间和CD4 + T细胞的患者 计数> 400/mm3。 任何接受过嵌合治疗的患者 抗CD4将受到严重不良事件的监视 感染，免疫抑制和抗感染药物史， 淋巴细胞恢复和一般疾病状况。 安全评估是 每6个月进行一次，直到绝对淋巴细胞计数（ALC）为> 400个单元/mm3。 我们有五名患者完成了随机阶段的 该研究和所有患者均显示出疾病降低30％ 活动。 所有五名患者接受了开放标签的嵌合抗CD4 最高剂量为50 mg/天，没有明显的治疗 改善其疾病活动。 随机研究停止了 过早，因为临时分析显示没有差异 安慰剂和治疗组之间的功效。 我们已经完成了 我们所有五名患者的安全随访。 该研究已关闭。