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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss EE Study Group
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• Adult patients with severe, corticosteroid-dependent eosinophilic esophagitis

Exclusion Criteria:

• Pregnancy

• Evidence of latent or active tuberculosis

• Other contra-indications for TNF-alpha blockers

• Unstable medical conditions

• Malignancies