Status:
TERMINATED
Infliximab Top-down in Pediatric Crohn
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
University of Roma La Sapienza
Universitair Ziekenhuis Brussel
Conditions:
Crohn's Disease
Eligibility:
All Genders
3-17 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-up treatment...
Detailed Description
Objective: The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-u...
Eligibility Criteria
Inclusion
- Children (age 3-17 years, both male and female) with new-onset, untreated CD with moderate-to-severe disease activity assessed by a wPCDAI \>40 will be eligible for inclusion after a diagnosis of CD was made based on the Porto criteria.
Exclusion
- Patients with the following characteristics will be excluded: immediate need for surgery, symptomatic stenosis or stricture in the bowel due to scarring, active perianal fistulas, severe co-morbidity, severe infection such as sepsis or opportunistic infections, positive stool culture, positive Clostridium difficile assay, positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy, those already started with CD specific therapy.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01880307
Start Date
January 1 2013
Last Update
July 2 2015
Active Locations (2)
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1
Sapienza University
Rome, Italy
2
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3000 CA