Safety, Efficacy, and Cost-effectiveness of a Reduced Infliximab Infusion Time Protocol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit
研究概览
简要总结
Remicade is a common medicine used for the treatment of inflammatory bowel disease. This medication is given as an intravenous infusion over 2 hours. Studies have suggested it is safe to give the infusion at a faster rate. The investigators would like to see if the infusion can be given over 1 hour. The investigators expect that increasing the rate of infusion WILL NOT lead to an increase in infusion reactions and will be just as safe and effective as the standard 2 hours dose.
详细描述
1.1 Infliximab use in IBD
Inflammatory bowel disease (IBD) affects 349 per 100,000 adults in the United States and is associated with significant morbidity and mortality. Infliximab is an effective and commonly used medication to treat patients with IBD, but a main safety concern is an antibody-induced infusion reaction. The incidence of infusion reactions is ~6.5%, with mild, moderate, or severe reactions occurring in 3.1%, 1.2%, and 1% of infusions, respectively. Because of the concern for infusions reactions, infliximab is FDA approved to be infused over 2 hours or more. The typical interval for infusions is every eight weeks but is at times reduced to every 4 weeks in patients with IBD. This infusion time represents a significant inconvenience to patients who receive regular maintenance infusions.
1.2 Accelerated Infliximab Infusions
Multiple studies outside of the United States have demonstrated that a shortened infusion time to one hour, and even thirty minutes is safe and tolerable with similar rates of infusion reactions compared to an infusion time of two hours. However, these studies have differed in dosing, interval, pre-medication allowed in the study, and they are not randomized controlled studies. It has also been shown that reducing infusion times leads to cost savings and increased patient satisfaction. A recent study conducted in the United States at the University of California in San Francisco, confirmed that a shortened infusion time of one hour is safe and tolerated.
1.3 Rationale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Must be at least 18 years of age
- •Must have a diagnosis of IBD
- •Must be receiving Infliximab or biosimilar drug infusions for IBD at one of the study infusion centers - Center for Advanced Medicine, Barnes-Jewish West County, Barnes-Jewish South County infusion centers, or receiving infusion through BJC Home Care Services/ Barnes Home Health Company.
- •Must tolerate the three induction doses or be tolerating current maintenance dosing without an infusion reaction to qualify for randomization.
排除标准
- •Those receiving Infliximab for an indication other than IBD (the investigators will include patients receiving infliximab or biosimilar drug for both IBD and an additional autoimmune disease)
- •Patients with history of a moderate or severe infusion reactions to infliximab or to an infliximab biosimilar as defined in section 7
- •Patients with known antidrug antibodies to infliximab
- •Patients who are restarting infliximab (patients who have received infliximab within the past year but have now had an interval greater than 13 weeks between prior dose) must tolerate the three induction doses to qualify for randomization
- •Patients receiving an additional infusion concomitant with infliximab (e.g. IV iron)
- •Patients who decline to participate in the trial
研究组 & 干预措施
2-hour infusion of infliximab
2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group.
干预措施: Infliximab (Drug)
1-hour infusion of infliximab
1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group.
干预措施: Infliximab (Drug)
结局指标
主要结局
Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit
时间窗: Median of 12 months in the control and a median of 14 months in the study group.
Acute infusion reaction is defined as any reaction occurring during or within 1 hour after completion of the infusion. It will be separated into mild reactions and moderate/severe reactions as outlined below. Mild/Localized Reaction Pruritus Flushing (facial erythema) Rash/Urticaria Rigors Swelling Moderate/Severe Reaction Fever (temperature \> 38.3 degree Celsius) Heart Rate greater than 120 Dyspnea/Shortness of breath Decrease in consciousness Hypotension defined as decrease in baseline SBP by \>20 mmHg or SBP \<85 Bronchospasm or laryngospasm Anaphylactic shock of one hour, to the standard two-hour infusion.
次要结局
- Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used(Median of 12 months in the control and a median of 14 months in the study group.)
- Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Duration of Follow up (in Months)(Median of 12 months in the control and a median of 14 months in the study group.)
- Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Median Number of Infusions(Median of 12 months in the control and a median of 14 months in the study group.)
- Cost Saving Analysis(Median of 12 months in the control and a median of 14 months in the study group.)
研究者
Chien-Huan Chen
Professor of Medicine
Washington University School of Medicine