NL-OMON53027招募中3 期
AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES - ETRO - OLE (GA28951)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 33
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 64（—）
入选标准
- •Part 1 (Open-label Extension; OLE), - Patients previously enrolled in Phase III
- •controlled studies who meet the eligibility criteria for open-label etrolizumab
- •for those studies as described in the protocol, Part 2 (Safety Monitoring; SM),
- •- Patients who participated in one of the etrolizumab Phase III studies and are
- •not eligible or chose not to enter Part 1 (OLE)
- •- Patients who transfer from Part 1 (OLE)
- •- Completion of the 12-week safety follow-up prior to entering., A complete
- •list of inclusion criteria can be found in the protocol
排除标准
- •Part 1 (Open-label Extension; OLE), - Any new, significant, uncontrolled
- •- Receipt of the following since commencement of the Phase II OLE or
- •Phase III controlled studies: Use of anti-adhesion molecules, Part 2 (Safety
- •Monitoring; SM), - No exclusion criteria, A complete list of exclusion criteria
- •can be found in the protocol
研究者
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