TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease (TOPIT)
Pediatric Crohns Disease
About this trial
This is an interventional treatment trial for Pediatric Crohns Disease
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients of both sexes with Cohn's disease
- Assured diagnosis of Cohn's disease according to the Porto criteria
- Regular attendance of gastroenteric consultations at one of the study centers
- Minimum patients age of 6 years, maximum age of 16 years
- Infliximab therapy with permitted / without co- medication
- Completed induction with Infliximab in accordance to the approved conventional scheme with primary therapy response
- Written consent of the patient and the legal guardian
Exclusion Criteria:
- No consent of the patient and / or legal guardian
- Serious side effects under Infliximab therapy in the past
- Primary non-responder to Infliximab after first three cycles
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Conventional treatment
Intervention Group
The patients of the control group undergo Infliximab-maintenance according to the approved dosing scheme, initially with 5 mg/kg body weight Infliximab. Before each administration laboratory parameters will be controlled (Albumin, CrP, Calprotectin) and disease activity scores will be obtained (PCDAI / PUCAI). Infliximab trough levels will be assessed but not have any implication. In the presence of clinical signs of a disease exacerbation and after exclusion of other causes an adjustment of the dosage will follow for the next Infliximab-infusion: A) interval shortening, or B) Dose increase to 10 mg / kg body weight. With a clinical stable course of the disease without signs of deterioration, the dosage and the eight-week interval will be maintained.
Aiming to maintain the therapeutic window of Infliximab a de- or increase of the dose or infusion interval will be carried out for the following administration, provided the patient shows no signs of a clinical worsening. With good trough levels and clinically stable conditions the therapy will be continued without modification until next check-up. In the case of an eminent disease exacerbation Infliximab trough levels and the search for anti - Infliximab antibodies should guide further treatment decisions. With trough levels below the target range antibody testing should be performed.