EUCTR2014-002557-19-SK进行中（未招募）1 期
A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study
Mitsubishi Tanabe Pharma Corporation (MTPC)0 个研究点目标入组 80 人开始时间: 2014年11月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The subject showed a decrease in CDAI of at least 70 points from the baseline CDAI score (i.e., Visit 2) at Week 12 in the double-blind MT-1303-E13 study.
- •2. The subject completed the 14 week Treatment Period in the double-blind MT-1303-E13 study as per Protocol.
- •3. The subject is able to provide written informed consent and to comply with the requirements of the MT-1303-E14 Protocol during the study.
- •4. For subjects of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
- •For detailed information, please refer to the Protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 79
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Permanent discontinuation of study medication prior to the EOT Visit in MT-1303-E13
- •2. Newly diagnosed diabetes mellitus during the double blind MT-1303-E13 study.
- •For detailed information, please refer to the Protocol.
研究者
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