NCT00372723

Brief Summary

To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2

Status
withdrawn

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

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

4.9 years

First QC Date

September 5, 2006

Last Update Submit

April 25, 2013

Conditions

Toxic Epidermal Necrolysis

Keywords

toxic epidermal necrlysisten

Outcome Measures

Primary Outcomes (1)

  • 30 day mortality

    30 days

Secondary Outcomes (1)

  • Safety labs and adverse events

    30 days

Interventions

Remicaide (infliximab)DRUG

a single dose infusion of 5mg/kg Remicade (Infliximab)

Eligibility Criteria

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

You may qualify if:

  • Admission to burn unit with a histologic diagnosis of TENs

You may not qualify if:

  • Pregnancy
  • hypersensitivity to remicaide
  • history of heart failure
  • documented bacteremia
  • history of cancer
  • inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

Infliximab

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesErythema MultiformeErythemaSkin Diseases, VesiculobullousHypersensitivity, DelayedHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Richard Gamelli, MD

    Loyola University Medical Center, Department of Surgery

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

July 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 26, 2013

Record last verified: 2013-04