跳至主要内容
临床试验/JPRN-jRCT2080225027
JPRN-jRCT2080225027已完成Unknown

A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients

Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 6 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
Unknown
状态
已完成
入组人数
6

研究概览

简要总结

o new safety concern of satralizumab in NMOSD patients was observed from the study.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 12age old 至 <= 74age old(—)
性别
All

入选标准

  • Patients diagnosed as having either:
  • - NMO as defined by 2006 criteria
  • - NMOSD as defined by either of the following Wingerchuk 2007 criteria with anti aquaporin 4 antibody (AQP4Ab) seropositive status at screening
  • - NMOSD as defined by 2015 criteria

排除标准

  • (1) Patients who have history of Alemtuzumab, total body irradiation, or marrow transplant
  • (2) Any previous treatment with anti-cluster of differentiation (CD) 20, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline
  • (3) Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline.
  • (4) Treatment with any investigational agent within 3 months prior to baseline.

研究者

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