Prospective Analysis of Pharmacokinetic Infliximab data in Paediatric Inflammatory Bowel Disease patients (Pro-RAPID)
- Conditions
- Crohn's DiseaseTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the proportion of patients with IFX trough level = 5 µg/mL at week 12 without treatment escalation;Secondary Objective: -To assess the efficacy of an IFX intensified induction scheme in obtaining clinical and biochemical remission at weeks 4, 12, and 24 without treatment escalation. -To assess whether an intensified induction scheme increases the frequency of ATI and/or of infusion reactions/adverse reactions. -To assess factors that will predict who will respond to IFX based on proteomic analysis.;Primary end point(s): The primary endpoint is the proportion of patients with IFX TL = 5 µg/mL at week 12 without treatment escalation. Within the RAPID study, 68% of patients < 10 years of age with CD had TLs <5 µg/mL at week 14.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Proportion of patients with IFX TL = 5 µg/mL at week 24 without the need for treatment escalation,proportion of patients in clinical and/or biochemical remission at weeks 4, 12, and week 24 without the need for treatment escalation in patients with TL > 5 µg/mL and in patients with TL < 5 µg/mL, predictors of IFX TLs at weeks 4, 12, and 24