Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372723
Recruitment Status : Withdrawn (slow enrollment)
First Posted : September 7, 2006
Last Update Posted : April 26, 2013
Information provided by (Responsible Party):
Loyola University

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.

Condition or disease Intervention/treatment Phase
Toxic Epidermal Necrolysis Drug: Remicaide (infliximab) Phase 2

Detailed Description:
This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
Study Start Date : July 2006
Primary Completion Date : June 2011
Study Completion Date : June 2011

Intervention Details:
    Drug: Remicaide (infliximab)
    a single dose infusion of 5mg/kg Remicade (Infliximab)

Primary Outcome Measures :
  1. 30 day mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Safety labs and adverse events [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admission to burn unit with a histologic diagnosis of TENs

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372723

Sponsors and Collaborators
Loyola University
Principal Investigator: Richard Gamelli, MD Loyola University Medical Center, Department of Surgery

Responsible Party: Loyola University Identifier: NCT00372723     History of Changes
Other Study ID Numbers: 108983
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Loyola University:
toxic epidermal necrlysis

Additional relevant MeSH terms:
Stevens-Johnson Syndrome
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Skin Diseases
Erythema Multiforme
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents