A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 主要终点
- Clinical response at Week 10, defined as a decrease from baseline in the PCDAI score of at least 15 points with a total score of no more than 30 points at Week 10.
研究概览
简要总结
A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with moderate to severe Crohn's Disease
详细描述
This is a medical research study to evaluate the safety and effectiveness of an antibody called infliximab (Remicade) in the treatment of children with Crohn's disease. In this study, subjects will receive multiple doses of infliximab over 62 weeks. The goal of the study is to ensure that the medication is safe and effective in children when it is given for an extended period of time. All subjects will receive an induction regimen of 5 mg/kg infliximab at Weeks 0, 2, and 6. Subjects will then receive either 5 or 10 mg/kg infliximab either every 8 or 12 weeks for up to 46 weeks followed by an open label extension for up to three additional years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 6 and 17 years
- •Have had Crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy
- •Have active Crohn's disease despite adequate current treatment with an immunomodulator (ie, AZA, 6-MP, or MTX).
排除标准
- •Disease complications for which surgery might be indicated
- •Surgery for bowel diversion with placement of a stoma within 3 months prior to screening
- •Positive stool examination for enteric pathogens including Giardia lamblia, Clostridium difficile, Shigella species, and Salmonella species.
结局指标
主要结局
Clinical response at Week 10, defined as a decrease from baseline in the PCDAI score of at least 15 points with a total score of no more than 30 points at Week 10.
次要结局
- Clinical response at Week 54; Clinical remission at Week 54; Change from baseline in corticosteroid use at Week 54; Change from baseline in height status at Week 54