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Top-down Infliximab Study in Kids With Crohn's Disease

CompletedPhase 4

Sponsor: Erasmus Medical Center

Conditions: Crohn's Disease

Interventions: Infliximab, Prednisolone, Exclusive enteral nutrition, Azathioprine

Countries: Belgium, Finland, Netherlands

The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.

Eligibility overview

Sex: ALL

Age: 3 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Children (age 3-17 years, both male and female, weight \>10kg) 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 Criteria:

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,
* patients with a suspected or
* definitive pregnancy

Locations (13)

Brussels, Belgium
Leuven, Belgium
Helsinki, Finland
Rotterdam, South Holland, Netherlands
Amsterdam, Netherlands
Amsterdam, Netherlands
Breda, Netherlands
Enschede, Netherlands
Leiden, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Utrecht, Netherlands
Zwolle, Netherlands