NCT00562887终止2 期
A Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease.
Abbott61 个研究点 分布在 5 个国家目标入组 246 人开始时间: 2007年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 246
- 试验地点
- 61
- 主要终点
- Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
研究概览
简要总结
To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Crohn's disease for greater than 4 months confirmed by endoscopy or radiologic evaluation.
- •CDAI score of >= 220 and <= 450 at Week
- •Males and females >= 18 years and < 75 years of age at the Screening visit.
- •Judged to be in generally good health as determined by the Investigator.
排除标准
- •Current diagnosis of the colitis other than Crohn's disease.
- •Symptomatic known strictures.
- •Surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
- •Ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
- •Short bowel syndrome as determined by the investigator.
- •Infection or risk factors for severe infections.
- •Females who are pregnant or considering becoming pregnant during the study, or breast-feeding.
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Biological)
400 mg
Experimental
干预措施: ABT-874 (Biological)
700mg
Experimental
干预措施: ABT-874 (Biological)
结局指标
主要结局
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
时间窗: Week 6
次要结局
- Patient reported outcomes, clinical response indicators, safety parameters(Weeks 12 and 24)
研究者
研究点 (61)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque PsoriasisPsoriasisNCT00292396AbbVie (prior sponsor, Abbott)180
已完成
3 期
A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque PsoriasisPlaque PsoriasisNCT00570986AbbVie (prior sponsor, Abbott)1,465
已完成
2 期
Safety and Efficacy Study in Subjects With Diabetic Neuropathic PainDiabetic NeuropathiesDiabetic Neuropathy, PainfulDiabetic PolyneuropathyNeuralgia, DiabeticDiabetic NeuralgiaNCT00507936AbbVie (prior sponsor, Abbott)280
已完成
3 期
A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque PsoriasisPsoriasisNCT00679731AbbVie (prior sponsor, Abbott)317
已完成
2 期
Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)Advanced or Metastatic Non-Small Cell Lung CancerNCT00716534AbbVie (prior sponsor, Abbott)145