Harmonized supportive care with placebo cyclosporine days 0-14 and etanercept placebo days 0 and 3

Harmonized supportive care with placebo etanercept days 0 and 3

Harmonized supportive care with placebo cyclosporine days 0-14

Stevens-Johnson Syndrome

Toxic Epidermal Necrolyses

Harmonized supportive care

Cyclosporine 5 mg/kg bid days 0-14

Etanercept 50 mg sc day 0 and day 3

Vanderblt University Medical Center

NATIENS: Optimal Management and Mechanisms of SJS/TEN

NATIENS: A Phase III Randomized Double-Blinded Placebo Controlled Study to Determine the Optimal Management and Mechanisms of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Patients will be assessed by two independent raters (burn surgeons, dermatologists, wound care experts) to determine the day of full re-epithelialization. For disagreements on the day of re-epithelialization the case with supporting photographs will be referred to an independent adjudication committee comprised of a minimum of three experts (a burn surgeon, dermatologist, wound care expert). In the instance of death will be the maximum period of re-epithelialization (21 days + 1)

Progression will be considered significant if there are any new blistering lesions or any new detached or detachable skin.

Number of participants with mortality at 30 days, 3 months and 1 year

Number of participants with Actual mortality versus expected mortality for each SCORTEN risk

Time to cessation of acute ocular involvement acutely then extent of ocular incolvement at follow-up will be assessed by two independent ophthalmology experts. Will be tracked by photography

Adverse events due to assigned treatment arm

Featured exploratory secondary outcome measuring difference overtime within an individual as well as differences between treatment arms at various time measurements.

C0 and C2 levels will be measure in all patients with analysis after unblinding in those randomized to cyclosporine (n=89). Relationship between levels and adverse drug events and treatment outcome will be measured.

There are no plans to share individual participant data available to other researchers.

cholic acid/hemorrhage

NATIENS: Optimal Management and Mechanisms of SJS/TEN

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