NCT01053559已完成不适用
Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy
Shafran Gastroenterology Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mucosal Healing
研究概览
简要总结
Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel Crohn's disease. Endoscopic healing is an important endpoint to measure response to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 with confirmed Crohn's disease that includes small bowel disease
- •Moderately to severely active disease (CDAI score >220 and < 450)
- •Stable doses of steroids, 5-ASA, antibiotics, Immunosuppressants
排除标准
- •Any and all contraindications to the use of certolizumab pegol (including but not limited to hepatitis, infection, abscess, malignancy, congestive heart failure [CHF], cytopenia)
- •Small bowel obstruction, stricture, or any contraindication for capsule endoscopy
- •Previous treatment with certolizumab pegol
- •Are pregnant or lactating
研究组 & 干预措施
certolizumab pegol
Other
Subjects will receive FDA approved Cimzia injections as indicated on the product label. Subjects will undergo 3 wireless capsule endoscopies, one at screening,Day 84 and Day 168 as well as monthly bloodwork.
干预措施: certolizumab pegol (Drug)
结局指标
主要结局
Mucosal Healing
时间窗: 180 Days
次要结局
- C-Reactive Protein (CRP) Level(180 Days)
研究者
Ira Shafran M.D.
Principal Investigator
Shafran Gastroenterology Center
研究点 (1)
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