Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS

ErasmusMC0 个研究点目标入组 90 人开始时间: 2013年7月16日最近更新: 2014年8月11日

适应症

试验速览

暂无简介。

•Children (age 1-17 yrs, both male and female) with new-onset, untreated CD with moderate-to-severe disease activity assessed by a PCDAI > 30 will be eligible for inclusion after a diagnosis of CD based on oesophagogastroduodenoscopy, ileocolonoscopy including histology of multiple biopsies and small bowel imaging, according to the Porto criteria.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 90
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients with immediate need for surgery, symptomatic stenosis or stricture in the bowel due to scarring, severe co-morbidity, severe infection such as sepsis and opportunistic infections, positive stool culture or Clostridium difficile assay, a positive tuberculin test or a chest radiograph consistent with tuberculosis or a malignancy will be excluded. Patients that have already started drug treatment will be excluded

发起方

ErasmusMC