drugset / Trial / NCT00523354

Off Label Use of Infliximab in Adult Patients With Severe Eosinophilic Esophagitis

NCT00523354

Phase 2 Completed Swiss EE Study Group
NaSingle-groupOpen-labelTreatment

Summary

Eosinophilic Esophagitis (EE) is a chronic inflammatory disorder of the esophagus with a constantly increasing prevalence. It has been demonstrated that the expression of the cytokine TNF-α is up regulated in EE and that this pro-inflammatory cytokine is highly expressed by the keratinocytes of the esophageal epithelium in patients with active EE. Furthermore, it has been shown that TNF-α is capable to induce eotaxin-3 production in keratinocytes. These results suggest that TNF-α plays a crucial role in the pathogenesis of EE. Based on these findings, the investigators plan a prospective T1 translational study with the purpose to evaluate the efficacy of an Infliximab monotherapy in adult patients with severe, corticosteroid-dependent EE.

Timeline

Start
2007-08
Primary completion
2007-09
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 5 mg/kg

Indications