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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00372723

Enrollment

Registered

2006-09-07

Start date

2006-07-31

Completion date

2011-06-30

Last updated

2013-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Toxic Epidermal Necrolysis

Keywords

toxic epidermal necrlysis, ten

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.

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.

Interventions

DRUGRemicaide (infliximab)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
30 day mortality	30 days

Secondary

Measure	Time frame
Safety labs and adverse events	30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026