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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 11 August 2014
Main ID:  EUCTR2012-000645-13-BE
Date of registration: 16/07/2013
Prospective Registration: Yes
Primary sponsor: ErasmusMC
Public title: Infliximab as firsdt treatment instead of second line treatment in Crohns disease
Scientific title: Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS
Date of first enrolment: 09/09/2013
Target sample size: 90
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000645-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Different treatment regimen Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Belgium Netherlands
Contacts
Name: L. de Ridder   
Address:  Dr Molewaterplein 60 3015 GJ Rotterdam Netherlands
Telephone: 31107040704
Email:
Affiliation:  ErasmusMC-Sophia
Name: L. de Ridder   
Address:  Dr Molewaterplein 60 3015 GJ Rotterdam Netherlands
Telephone: 31107040704
Email:
Affiliation:  ErasmusMC-Sophia
Key inclusion & exclusion criteria
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

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion

Primary Outcome(s)
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(s)
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
Secondary ID(s)
2012-000645-13-NL
ITSKids
Source(s) of Monetary Support
ZonMw
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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