Crohn's disease
Conditions
Interventions
Product Name: Infliximab
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Anti-TNF-a 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 [11]. 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. Are the trial subjects under 18? yes Number of subjects for this age range: 50 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule in improving drug exposure (=therapeutic trough levels) without treatment escalation in pediatric CD patients.;Secondary Objective: • Proportion of patients with IFX TL = 5 µg/mL at week 24 without the need for treatment escalation • Clinical and biochemical remission at weeks 4, 12, and 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. Factors included in this analysis will be sex, age, body mass index (BMI), wPCDAI, IBD laboratory values, ATI, dose, and interval of IFX infusions • Development of ATI until week 24 • Prediction of patients who will respond vs. those who will not despite adequate TLs at weeks 12 and 24 based on proteomics analysis by OLINK • Evaluation of quality of life at baseline, weeks 4, 12, and 24 in all patients • Adverse event rate over time;Primary end point(s): Proportion of patients with IFX TL = 5 µg/mL at week 12 without treatment escalation.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with IFX TL = 5 µg/mL at week 24 without the need for treatment escalation • Clinical and biochemical remission at weeks 4, 12, and 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. Factors included in this analysis will be sex, age, body mass index (BMI), wPCDAI, IBD laboratory values, ATI, dose, and interval of IFX infusions • Development of ATI until week 24 • Prediction of patients who will respond vs. those who will not despite adequate TLs at weeks 12 and 24 based on proteomics analysis by OLINK • Evaluation of quality of life at baseline, weeks 4, 12, and 24 in all patients • Adverse event rate over time;Timepoint(s) of evaluation of this end point: See within description of secondary endpoints | — |
Countries
Italy, Netherlands
Contacts
Public ContactPrincipal investigator
Erasmus Medical Center
Outcome results
None listed