Infliximab Top-down Study in Kids with Crohn’s disease

INTERVENTION: Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion CONDITION: Crohn's disease Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: Main Objective: The primary objective of our study is to determine the efficacy and safety of top‐down IFX treatment in moderate‐to‐severe pediatric CD. Primary end point(s): The primary endpoint at 52 weeks is steroid free clinical remission. ; ; Secondary Objective: Secondary objectives are determination of pharmacokinetic data and predictors of response to IFX in pediatric CD. Timepoint(s) of evaluation of this end point: 52 weeks SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints will be: ; • Mucosal healing at 10 weeks assessed by endoscopy ; • Endoscopy at 52 weeks will be performed to assess mucosal healing in case of persisting complaints ; • Faecal calprotectin performed at both 10 and 52 weeks as an exploratory endpoint. Duration of clinical remission and clinical response assessed by PCDAI since induction ; • Number of flares ; • Prevention of complications (fistulas, strictures, need for surgery) at 52 weeks and at long‐term follow‐up (5 years after last visit) ; • Growth ; • Cumulative use of steroids (apart from steroids prescribed in induction phase of treatment arm 2) ; • Cumulative use of IFX ; • Loss of IFX response ; • PK data ; Timepoint(s) of evaluation of this end point: 52 weeks INCLUSION CRITERIA: Children (age 1‐17 yrs, both male and female) with new‐onset, untreated CD with moderate‐to‐severe disease activity assessed by a PCDAI > 30 will be eligible for inclusion after a diagnosis of CD based on oesophagogastroduodenoscopy, ileocolonoscopy including histology of multiple biopsies and small bowel imaging, according to the Porto criteria. Are the trial subjects under 18? yes Number of subjects for this age range: 90 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