EUCTR2010-022506-41-IT进行中（未招募）不适用
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) - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 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
- •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: 0
- •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
- •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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