NCT00656890已完成2 期
A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis
Bristol-Myers Squibb51 个研究点 分布在 8 个国家目标入组 110 人开始时间: 2008年4月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 51
- 主要终点
- Change in Mayo score at Day 57 compared with Screening
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
- •Mayo score of 6 to 10 points with moderate to severe disease on endoscopy
- •Subjects on the following medications;
- •prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
- •5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
- •AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
- •Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)
排除标准
- •Anti-TNF therapy within 8 weeks before study drug administration
- •Contraindication to colonoscopy or sigmoidoscopy
- •Primary or secondary immunodeficiency
- •Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
- •History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
- •Evidence of acute or chronic infection
- •Clinically significant disease requiring medication
结局指标
主要结局
Change in Mayo score at Day 57 compared with Screening
时间窗: Day 57
次要结局
- the remission rate(Day 57)
研究者
研究点 (51)
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