CTRI/2017/04/008364已完成3 期
An Open-Label Extension and Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies. - Not applicable
F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
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
入选标准
- •Part 1 (OLE):
- •Patients who were previously enrolled in the Phase II OLE study or the Phase III controlled studies and meet the eligibility criteria for treatment with open-label etrolizumab
- •For women who are not postmenopausal or surgically sterile or use a highly effective method of contraception
- •For men: agreement to remain abstinent
- •Part 2 (SM):
- •Patients who participated in one of the etrolizumab Phase III study GA29102 and are not eligible or chose not to enroll in Part 1 (OLE)
- •Patients who transfer from Part 1 (OLE) of this protocol
- •Ability and willingness to provide written informed consent and comply with the requirements of Part 2 (SM) of the OLE-SM protocol
排除标准
- •Part 1 (OLE)
- •Withdrawal of consent from the Phase II OLE study or any of the Phase III studies
- •Patients who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949,GA29102, and GA29103
- •Inability to comply with the study protocol, in the opinion of the investigator
- •Pregnancy or lactation
- •Exclusion Due to Safety Reasons
- •Part 2 (SM)
- •No exclusion criteria
研究者
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