JPRN-UMIN000024265已完成2 期
Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus - Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus
Department of Dermatology, Keio University School of Medicine0 个研究点目标入组 10 人开始时间: 2016年10月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Women who are nursing, pregnant, intending to be pregnant. 2. Patients with a history of hypersensitivity or shock to humanized or mouse monoclonal antibodies or mouse-derived components. 3. Patients with severe and uncontrollable organ failure. 4. Patients with any concomitant condition that required treatment. 5. Patients with an active infection. 6. Patients who received an infusion of antibiotics or patients with an infectious disease that requires hospitalization. 7. Patients who received an oral administration of antibiotics. 8. Patients with a history of a bacteremia caused by Staphylococcus aureus or Pseudomonas aeruginosa. 9. Patients who experienced bone soft tissue infections or any type of organ abscess. 10. Patients with a history of severe recurrent infection or chronic infection. 11. Patients with a malignant tumor or a history of a malignant tumor. 12. Patients with a history of addiction to alcohol or drugs. 13. Patients with a severe psychiatric disorder. 14. Patients in whom an operative treatment has been performed. 15. Patients with a history of severe infection after starting immunosuppressive agent administration. 16. Patients who previously received administration of anti-CD20 antibody. 17. Patients who have used a live vaccine or attenuated vaccine. 18. Patients in whom the following clinical laboratory abnormalities are noted during the SCR period. 19. Patients who have begun or increased the dose of an oral immunosuppressive agent. 20. Patients who received IVIG. 21. Patients who received intravenous steroid pulse therapy. 22. Patients who received plasmapheresis. 23. Patients who received intravenous cyclophosphamide pulse therapy . 24. Patients treated with other investigational drugs. 25. Patients who are determined as unfit for the enrollment in the study after an investigation.
研究者
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