Managing Infliximab Reinduction After Temporary Discontinuation of Drug
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Failure Rate
研究概览
简要总结
The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years or older who are willing and able to provide informed consent
- •HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
- •History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
- •Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
- •Infliximab drug holiday for at least 12 weeks.
排除标准
- •Inability or unwillingness to provide informed consent
- •Pregnant patients
- •Prior history of serious infusion reaction to IFX
研究组 & 干预措施
Infliximab at weeks 0,2, and 6
In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6.
干预措施: Infliximab at weeks 0,2, and 6 (Drug)
Infliximab at weeks 0,4, and 8
In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8
干预措施: Infliximab at weeks 0,4, and 8 (Drug)
Infliximab at weeks 0, and 8
In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8.
干预措施: Infliximab at weeks 0 and 8 (Drug)
结局指标
主要结局
Failure Rate
时间窗: One year
Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.
次要结局
- Long-term clinical response(One year)
- Short-term changes in patient Quality of Life(One Year)
- Short-term clinical response(One year)
- Long-term changes in patient Quality of Life(One Year)
- Fecal calprotectin measurements(One year)