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

Toxic Epidermal Necrolysis Clinical Trial

Official title:

Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00372723
• Other study ID #: 108983
• Status: Withdrawn
• Phase: Phase 2
• First received: September 5, 2006
• Last updated: April 25, 2013
• Start date: July 2006
• Est. completion date: June 2011

Study information

• Verified date: April 2013
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day mortality		30 days	No
Secondary	Safety labs and adverse events		30 days	Yes