NL-OMON55460已完成3 期
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn*s Disease - Vedolizumab SC Open-Label Extension [MLN0002SC-3030]
Takeda0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- 18 至 99（—）
入选标准
- •The subject has previously participated in Study MLN0002SC-3027 or
- •MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study
- •drug well. Subjects who withdraw early from Study MLN0002SC-3027 or
- •MLN0002SC-3031 must have withdrawn due to treatment failure (ie, as determined
- •by disease worsening or need for rescue medications from Week 14 of the
- •respective study) during the Maintenance Period.
排除标准
- •* The subject required surgical intervention for UC or CD during or after
- •participation in Study MLN0002SC-3027 or MLN0002SC-3031, currently requires
- •surgical intervention for UC or CD, or is anticipated to require surgical
- •intervention for UC or CD during this study.
- •* The subject has withdrawn from Study MLN0002SC-3027 or MLN0002SC-3031 due to
- •a study drug-related adverse event (AE).
研究者
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