NCT00523354

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

August 30, 2007

Last Update Submit

April 6, 2009

Conditions

Esophagitis

Keywords

Eosinophilic EsophagitisTNF-alphaTNF-alpha BlockadeInfliximab

Outcome Measures

Primary Outcomes (1)

  • Tissue eosinophilia before and after therapy

Study Arms (1)

1 (open-label)

EXPERIMENTAL

prospective, open label, uncontrolled trial

Drug: Infliximab

Interventions

InfliximabDRUG

Induction therapy with 2 infusions, each 5 mg/kg body weight within 2 wks

Also known as: Remicade
1 (open-label)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with severe, corticosteroid-dependent eosinophilic esophagitis

You may not qualify if:

  • Pregnancy
  • Evidence of latent or active tuberculosis
  • Other contra-indications for TNF-alpha blockers
  • Unstable medical conditions
  • Malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EE-Clinics, Praxis Roemerhof

Olten, Canton of Solothurn, 4600, Switzerland

Location

MeSH Terms

Conditions

EsophagitisEosinophilic Esophagitis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hans-Uwe Simon, MD and PhD

    Deaprtment of Pharmacology, University Bern, Bern, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

CH(1)