An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease
研究概览
简要总结
Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum.
This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must Be ages 18-75
- •Must have both inflammatory bowel disease and moderate to severe pyoderma gangrenosum
- •Must never have received Infliximab for the treatment of pyoderma gangrenosum
排除标准
- •Have had any previous treatment with monoclonal antibodies other than infliximab used to treat IBD or antibody fragments.
- •Have a history of serious infections
研究组 & 干预措施
Infliximab
Single arm open label IV Infliximab given at weeks 1,2,14,22
干预措施: Infliximab (Drug)
结局指标
主要结局
The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease
时间窗: Week 26
Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.
次要结局
未报告次要终点
研究者
Neil Korman
Principle Investigator
University Hospitals Cleveland Medical Center