Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab
研究概览
简要总结
There is little data published on the long term durability of infliximab in pediatric patients. In particular a focus on durable remission, frequency of dose/frequency change and switch within class. Moreover 10 years of safety experience is rarely reported in children.
The overall objective is to evaluate the persistence of infliximab as well as dosing strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab Regarding persistence of infliximab the investigators will be focusing on the proportion of patients who continue to have a durable response or remission to infliximab.
The investigators will be assessing this by measuring the frequency of dose escalation, proportion of patients needing frequency change and proportion of patients switched to adalimumab or certolizumab.
Safety outcomes will focus on frequency of malignancies, infections and immunogenecity
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent
排除标准
- •not exposed to infliximab
结局指标
主要结局
Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab
时间窗: 10 years
次要结局
- Frequency of concomitant immunomodulator use in children on infliximab(10 years)
- Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators(10 years)
研究者
Marla Dubinsky
Director Pediatric IBd Center
Cedars-Sinai Medical Center