EUCTR2014-002557-19-CZ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9月30日最近更新:
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 completed the 14 week Treatment Period in the doubleblind
- •MT-1303-E13 study as per Protocol.
- •2. The subject is able to provide written informed consent and to comply
- •with the requirements of the MT-1303-E14 Protocol during the study.
- •3. 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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