NATIENS: Optimal Management and Mechanisms of SJS/TEN (NCT02987257) | Clinical Trial Compass
CompletedPhase 3
NATIENS: Optimal Management and Mechanisms of SJS/TEN
United States2 participantsStarted 2023-03-21
Plain-language summary
The North American Therapeutics in Epidermal Necrolysis Syndrome (NATIENS) study is a multicenter double-blind randomized controlled assessment of two arms - one of systemic immunomodulatory therapy (etanercept) and one of supportive care deemed to be the current standard of care. We will leverage the opportunity of this controlled design to collect multiples samples with an aim to discover new genetic and biological markers for prevention and early diagnosis and define cellular and molecular mechanisms to facilitate discovery of promising treatment strategies. This study has been preceded by a planning phase to ensure testing and development of harmonized supportive care infrastructure and operating procedures across sites.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>18 years
✓. Subject and/or legally authorized representative must be able to understand and provide informed consent.
✓. Erythematous to dusky macules that show evidence of coalescing and/or denuding skin or blistering in a predominantly truncal distribution (Nikolsky sign = sloughing with direct lateral pressure on non-blistered but involved skin should be considered as a supportive feature
✓. At least two of the following:
✓. Mucous membrane involvement
✓. Prodromal symptoms including fever, myalgia, and headache
✓. Evidence of disease progression with an increasing number of skin lesions
✓. History of a newly used medication within the last 2 months that has not been tolerated for longer than 12 weeks in the past
Exclusion criteria
✕. Subject or legally authorized representative is not willing to provide informed consent.
✕. A serious drug reaction or possible alternative dermatologic diagnosis at the time of initial evaluation not in keeping with drug-induced SJS/TEN (e.g. graft versus host disease).
✕. If greater than 5 days has elapsed from onset of initial cutaneous or mucosal signs of the disease as obtained by patient history or documentation.
✕. Patients who have received etanercept in the last 6 months.
✕. Patients who in time since onset of SJS/TEN illness have received intravenous immune globulin (IVIg) or \> 2 doses of pulsed corticosteroid (defined by \> 250 mg prednisone equivalent) prior to enrollment in the study.
✕. End-stage liver disease (Child Pugh A, B or C or severe liver dysfunction).
✕. Grade 2 or higher liver dysfunction (alanine aminotransferase \>3 fold or bilirubin \>3 fold the upper limit of normal).