A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 20
- 主要终点
- Disease remission
研究概览
简要总结
To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.
详细描述
Participants will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As participants will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3,
- •Participant successfully completed all screening assessments in Protocol 603 as required by Protocol
- •Participant successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3,
- •Participant must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol
- •Participant must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.
排除标准
- •Participant is unwilling or unable to adhere to requirements of Protocol
- •Participant had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
- •Participant had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.
研究组 & 干预措施
Prochymal®
Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells.
干预措施: Prochymal® (Drug)
结局指标
主要结局
Disease remission
时间窗: 180 Days after first infusion in Protocol 603
Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ
次要结局
- Disease Improvement(180 Days after first infusion in Protocol 603)
- Number of Adverse events as a measure of safety(180 Days after first infusion in Protocol 603)
- Infusional toxicity as a measure of safety and tolerability(180 Days after first infusion in Protocol 603)
- Improvement in Quality of Life (IBDQ)(180 Days after first infusion in Protocol 603)