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

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Azathioprine; Infliximab; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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