Infliximab for Crohn's disease|Inflammatory bowel disease, unclassified (IBD-U)

Inclusion criteria

• {"criterion_text":"- Anti-TNF-α 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."}

Exclusion criteria

• {"criterion_text":"- Patients with the following characteristics will be excluded: -\tEstablished monogenetic IBD -\tDiagnosis with UC or IBD-U, ulcerative colitis like -\tSevere comorbidity (not related to IBD) -\tImmediate need for surgery (i.e., symptomatic stenosis or stricture in the bowel) -\tSevere infection such as sepsis or opportunistic infections, positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy -\tPregnancy, suspected or definitive -\tTreatment with anti-TNF or other biological drugs in the past -\tStart of corticosteroids or mesalazine less than 2 weeks prior to first IFX infusion -\tStart of Exclusive Enteral Nutrition less than 2 week prior to first IFX infusion"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the proportion of patients with IFX TL ≥ 5 µg/mL at week 12 without treatment escalation.","definition_or_measurement_approach":"Proportion of patients with infliximab trough level (IFX TL) ≥ 5 µg/mL measured at week 12 without requirement for treatment escalation."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with IFX TL ≥ 5 µg/mL at week 24 without the need for treatment escalation","definition_or_measurement_approach":"Proportion based on infliximab trough level (IFX TL) measured at week 24 without treatment escalation."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Clinical and/or biochemical remission assessed at weeks 4, 12 and 24 and stratified by IFX TL >5 µg/mL vs <5 µg/mL."}
• {"endpoint_text":"- predictors of IFX TLs at weeks 4, 12, and 24","definition_or_measurement_approach":"Analysis of predictors (covariates) of infliximab trough levels at weeks 4, 12 and 24."}

Other endpoints

• {"endpoint_text":"- Development of ATI until week 24","definition_or_measurement_approach":"Assessment of anti-infliximab antibodies (ATI) development up to week 24."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proteomics analysis (OLINK) to identify protein predictors of response vs non-response despite adequate IFX TLs at weeks 12 and 24."}
• {"endpoint_text":"- Evaluation of quality of life at baseline, week 12, and 24 in all patients","definition_or_measurement_approach":"Quality of life measured at baseline, week 12 and week 24 (instrument not specified in provided data)."}
• {"endpoint_text":"- Adverse event rate over time","definition_or_measurement_approach":"Recording and summary of adverse events over the study period (up to 24 weeks as per endpoints)."}

Netherlands

Earliest CTIS Part Ii Submission Date

26-07-2023

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

972

Number Of Sites

12

Number Of Participants

50

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands