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临床试验/JPRN-UMIN000000763
JPRN-UMIN000000763已完成未知

Phase II study of rituximab in patients with severe systemic lupus erythematosus - Rituximab clinical investigation in severe systemic lupus erythematosus

Zenyaku Kogyo Co., Ltd.0 个研究点目标入组 30 人开始时间: 2007年7月5日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
30

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
16years-old 至 75years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1.SLE exclusion 1)APS complication 2.General health exclusion 1)Pregnant women or lactating mothers 2)History of severe allergic or anaphylactic reactions to humanized antibodies, murine antibodies or murine-derived products 3)Uncontrolled disease in any organ system not related to SLE 4)Require treatments with systemic corticosteroid within one year, etc 3.Medication exclusion 1)Treated with any B-cell targeted therapy 2)Received other investigational drug within 6 months, or participating another clinical investigation 3)Received a vaccine within 4 weeks, etc 4.Laboratory exclusion 1)AST, ALT>Nu x 2.5 2)serum creatinine>8.0mg/dL 3)neutrophil<1500/uL 4)Hb<7.0g/dL 5)thrombocyte<10,000/uL 6)Positive HIV, HCV, HBs, HBc

研究者

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