JPRN-UMIN000028010已完成未知
Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever - Clinical trial of Tocilizumab for colchicine-resistant familial Mediterranean fever
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences0 个研究点目标入组 23 人开始时间: 2017年7月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 23
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
- 12years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients applicable to even one of the following are excluded from the subject (1) Women who are breast-feeding, pregnant, or may become pregnant (2) Patients who have obvious infection within 4 weeks before the study and judged inappropriate by investigator or clinical trial doctor (3) Patients with a history of hypersensitivity to the components of tocilizumab (4) Patients who are recently being treated with biologics. (5) Patients with past history of tocilizumab (6) Patients who are routinely using corticosteroids (excluding topical therapy such as external preparations) due to diseases other than familial Mediterranean fever and whose investigator or clinical trial doctor judged inappropriate (7) Investigational drugs Patients falling under any of the following criteria for examination within one week prior to initial administration 1) Leukocyte count less than 3500 / microL 2) neutrophil count less than 1000 / microL 3) Lymphocyte count less than 500 / microL 4) Number of platelets less than 100000 / microL (8) Patients with active tuberculosis (9) Patients with a history of intestinal perforation (10) Patients who have interstitial pneumonia and who are judged inappropriate by investigators or clinical trial doctors (11) Patient diagnosed as having a malignant tumor within 5 years before the study. (12) Patients with active type B or C hepatitis or patients with a history of hepatitis B (13) Patients who have complicated serious diseases and who are judged inappropriate by investigators or clinical trial doctors as clinical trials (14) Patients inoculated with a live vaccine within 6 weeks before the study (15) Patients who are using other investigational drugs within 6 months before the initial investigational drug (16)Patients judged inappropriate by investigators or clinical trial doctors
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