Crohn's disease
Conditions
Interventions
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
ErasmusMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children (age 3-17 years, 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
Exclusion criteria
Exclusion criteria: Patients with immediate need for surgery, symptomatic stenosis or stricture in the bowel due to scarring, severe co-morbidity, severe infection such as sepsis and opportunistic infections, positive stool culture or Clostridium difficile assay, a positive tuberculin test or a chest radiograph consistent with tuberculosis or a malignancy will be excluded. Patients that have already started drug treatment will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint at 52 weeks is steroid free clinical remission. ;Timepoint(s) of evaluation of this end point: 52 weeks;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. ;Secondary Objective: Secondary objectives are determination of pharmacokinetic data and predictors of response to IFX in pediatric CD. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 (PCDAI <=10) and clinical response (decrease from baseline in the PCDAI score = 15 points; total score =30) assessed by PCDAI since induction • Steroid free clinical remission at 260 weeks (5 years) • Biological free clinical remission at 52 weeks and at 260 weeks (5 years) • 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)260 weeks (5 years • Growth • Quality of life measuring at 0, 14, 52 and 260 weeksd using the Impact-II score • Cumulative use of steroids (apart from steroids prescribed in induction phase of treatment arm 2) • Cumulative use of IFX (apart from infliximab prescribed in induction phase of treatment arm 1) • Loss of IFX response • PK data • Safety of prescribed medication and adverse events will be checked and documented at every patient visit and at long-term follow-up (yearly, for 5 years after last visit). There will be special attention to infections, allergic reactions and abnormalities of the full blood count. ;Timepoint(s) of evaluation of this end point: 10 weeks, 52 weeks, 260 weeks | — |
Countries
Belgium, Italy, Netherlands
Contacts
Public ContactL. de Ridder
ErasmusMC-Sophia
Outcome results
None listed