EUCTR2010-022506-41-BE进行中（未招募）1 期
A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 386
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
- •Inclusion Criteria:
- •Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
- •Mayo score =6 with an endoscopic subscore of =2
- •Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •Diagnosis of Crohn’s Disease or Indeterminate Colitis
- •Diagnosis of UC that is limited to the rectum
- •Evidence of fulminant colitis, toxic megacolon, or bowel perforation
- •Current need for a colostomy or ileostomy
- •Previous total or subtotal colectomy
研究者
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