NCT00430898已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis
Cerimon Pharmaceuticals0 个研究点目标入组 181 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 主要终点
- Change in Mayo Score, Safety
研究概览
简要总结
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In addition to others,
- •Men or women age 18-75
- •Diagnosis of ulcerative colitis confirmed through screening endoscopy.
- •Extent of disease must involve at least the left colon
- •Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
- •Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry
排除标准
- •In addition to other protocol-defined conditions,
- •Pregnancy
- •Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
- •Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
- •Severely ill patients as evidenced by protocol-defined systemic criteria
- •Chest radiograph abnormalities consistent with an infectious process
- •History of colonic dysplasia
- •HIV infection
- •Known viral Hepatitis B or C infection
- •History of or exposure to tuberculosis within 6 months before study entry
研究组 & 干预措施
1. Placebo
Placebo Comparator
Placebo to mimic 40 mg of Simulect
干预措施: Basiliximab (Drug)
2. 40 mg Simulect
Experimental
40 mg of Simulect
干预措施: Basiliximab (Drug)
结局指标
主要结局
Change in Mayo Score, Safety
时间窗: At week 8
次要结局
- Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use(at week 4 and 8)
研究者
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