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

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ClinicalTrials.gov Identifier: NCT00372723
Recruitment Status : Withdrawn (slow enrollment)
First Posted : September 7, 2006
Last Update Posted : April 26, 2013
Sponsor:
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
Actual Primary Completion Date : June 2011
Actual 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00372723


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

Responsible Party: Loyola University
ClinicalTrials.gov 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
ten

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