Pharmacokinetic Infliximab Data in Pediatric Crohn's Disease

Launched by ERASMUS MEDICAL CENTER · Sep 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to give a medication called infliximab (IFX) to children with Crohn's disease (CD), a condition that causes inflammation in the intestines. Currently, the standard dose of IFX is based on studies in adults, but research shows that children may not respond as well to this dosing. The trial aims to find out if giving a higher dose of IFX initially can help children absorb more of the medication, leading to better treatment outcomes without needing to increase the dose later on.

To be eligible for this trial, children aged 1 to 15 years must be starting treatment with IFX for the first time and have been diagnosed with Crohn's disease. Important factors for participation include having certain symptoms that indicate a need for treatment, such as not improving with diet or steroids. Participants will receive IFX through an intravenous (IV) infusion and will be monitored over 24 weeks to check how well the medication is working. This study hopes to help improve Crohn's disease management in children and provide more effective treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Anti-TNF-α naïve children (age 1-15 years) with CD and an indication to start IFX treatment will be eligible for inclusion after a diagnosis of CD is made based on the Porto criteria. Indications of starting IFX treatment as per ECCO-ESPGHAN guidelines 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.
• Exclusion Criteria:
• • 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