Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Total numbers of infusion reactions related with infliximab infusion
研究概览
简要总结
This study aims to test the hypothesis that the accelerated infusion of infliximab is not inferior to the conventional 2 hour infusion with respect to the frequency of infusion reaction.
详细描述
The standard protocol of infliximab administration is the infusion for 2 hours. However, due to the discomfort of patients and limitation of medical resources, the accelerated infusion is more desirable if accelerated infusion does not increase the frequency of infusion reaction. Recent observational studies showed that the accelerated infusion of infliximab for 1 hour or 30 minutes did not increase the frequency of infusion reaction if patients had not shown infusion reactions during previous 4 infusions for 2 hours. However, there are no randomized trials comparing the safety of accelerated infusion protocol and standard infusion protocol yet.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving infliximab for Crohn's disease or ulcerative colitis
- •Ethnicity: Korean
- •Patients who did not show any infusion reactions during 4 times of infliximab (5mg/kg) infusions for 2 hours
- •Informed consents
排除标准
- •Sever cardiopulmonary diseases
- •Allergic diseases
- •Bronchial asthma
- •Allergic rhinitis
- •Atopic dermatitis
- •Other allergic diseases determined not suitable for study participation by investigators
- •Severe liver disease
- •Severe renal disease
- •Body weight over 100 kg
- •Other medical or surgical disease determined not suitable for study participation by investigators
研究组 & 干预措施
2 hours-infusion group
Number of patients: 57 (Standard 2 hours-infusion group)
干预措施: Standard 2 hours-infusion (Drug)
1 hour-infusion group
Number of patients: 59 (1 hour-infusion group)
干预措施: Accelerated 1 hour-infusion (Drug)
30 minutes-infusion group
Number of patients: 59 (30 minutes-infusion group)
干预措施: Accelerated 30 minutes-infusion (Drug)
结局指标
主要结局
Total numbers of infusion reactions related with infliximab infusion
时间窗: Within14 days after infliximab infusion
Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion
次要结局
- Numbers of severe infusion reactions related with infliximab infusion(Within14 days after infliximab infusion)
研究者
Suk-Kyun Yang
Professor
Asan Medical Center