EUCTR2013-004034-15-AT进行中（未招募）1 期
A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Subject successfully enrolled in and completed Study M14-115, including the Week 12 ileocolonoscopy.
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1) If the Week 12 (Study M14 115) colonoscopy shows evidence of dysplasia or a malignancy.
- •2) Subject is not in compliance with prior and concomitant medication requirements throughout Study M14-115.
- •3) Subject who developed active Tuberculosis (TB) during Study M14-115, or subject who is non compliant with prophylaxis for latent TB initiated per Study M14-115 procedures.
研究者
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