Prospective Analysis of Pharmacokinetic Infliximab data in Paediatric Inflammatory Bowel Disease patients (Pro-RAPID) - NL81536.078.22

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)0 个研究点目标入组 50 人开始时间: 2024年5月3日最近更新: 2024年7月22日

适应症

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•Anti-TNF-a naïve children (age 1-15 years) with CD or IBD-U and an indication to start IFX treatment will be eligible for inclusion after a diagnosis of CD is made based on the Porto criteria [10]. Indications of starting IFX treatment as per ECCO-ESPGHAN guidelines [9] include non-response after induction with exclusive enteral nutrition or steroids, non-response to immunomodulators, severe growth delay, extensive disease and/or structuring or penetrating disease, with or without perianal disease. Evaluation of the indication to start IFX is performed at the discretion of the attending physician.

•Patients with the following characteristics will be excluded: -Established monogenetic IBD -Diagnosis with UC or IBD-U, ulcerative colitis like -Active fistulizing/perianal disease at start of IFX treatment (patients with inactive fistulizing/perianal disease are allowed to participate) -Severe comorbidity (not related to IBD) -Immediate need for surgery (i.e., symptomatic stenosis or stricture in the bowel) -Severe infection such as sepsis or opportunistic infections, positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy -Pregnancy, suspected or definitive -Treatment with anti-TNF or other biological drugs in the past -Start of corticosteroids or mesalazine less than 2 weeks prior to first IFX infusion -Start of Exclusive Enteral Nutrition less than 2 week prior to first IFX infusion

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