NCT00105300已完成3 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 300
- 试验地点
- 110
- 主要终点
- Induction of clinical remission (CDAI score < 150 at Week 4)
研究概览
简要总结
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
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
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
- •Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
- •Normal lab parameters
- •Are willing to give informed consent
- •Have previously used and either were intolerant to or lost response to infliximab
排除标准
- •History of certain types of cancer
- •Diagnosis of ulcerative colitis
- •Pregnant female or breast feeding subjects
- •Known obstructive strictures
- •Surgical bowel resection in the past 6 months
- •History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
- •History of poorly controlled medical conditions
- •Specific doses and durations of Crohn's medications
- •Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab
结局指标
主要结局
Induction of clinical remission (CDAI score < 150 at Week 4)
次要结局
- Changes in IBDQ scores at Week 4
- Clinical response measured as
- Decrease in Baseline CDAI score >= 70 points at Week 4
- Decrease in Baseline CDAI score >= 100 points at Week 4
研究者
研究点 (110)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative ColitisUlcerative ColitisNCT00385736Abbott576
已完成
2 期
A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's DiseaseCrohn's DiseaseNCT00445432Abbott82
已完成
3 期
Remission in Subjects With Crohn's Disease, 1 Year PhaseCrohn's DiseaseNCT00055497Abbott276
已完成
2 期
ADalimumab in Persistent Early Oligoarthrits Study (ADEOS)OligoarthritisNCT04154852University of Leeds22
已完成
3 期
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseNCT02499783AbbVie205