Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02987257
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 years
2. Subject and/or legally authorized representative must be able to understand and provide informed consent.
3. 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
4. At least two of the following:
1. Mucous membrane involvement
2. Prodromal symptoms including fever, myalgia, and headache
3. Evidence of disease progression with an increasing number of skin lesions
5. History of a newly used medication within the last 2 months that has not been tolerated for longer than 12 weeks in the past
6. Females of childbearing potential must have a negative pregnancy test prior to randomization.
Exclusion Criteria:
1. Subject or legally authorized representative is not willing to provide informed consent.
2. 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).
3. 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.
4. Patients who have received etanercept in the last 6 months.
5. 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.
6. End-stage liver disease (Child Pugh A, B or C or severe liver dysfunction).
7. Grade 2 or higher liver dysfunction (alanine aminotransferase \>3 fold or bilirubin \>3 fold the upper limit of normal).
8. Any organ transplant.
9. Pre-existing Class III/IV Heart Failure (New York Heart Association Functional Classification).
10. Multiple Sclerosis or other demyelinating diseases.
11. Pregnancy or breastfeeding.
12. Current or past history of immune checkpoint inhibitor therapy for cancer.
13. Absolute need for a drug that interacts with cyclosporine without an appropriate substitution.
14. History of other immunosuppressive or immunomodulatory therapy that could significant impact treatment or interpretation of response to treatment (i.e. azathioprine, methotrexate, mycophenolate mofetil, mycophenolate sodium, rituximab, JAK inhibitors, IL-17 inhibitors, IL-23 inhibitors, other TNF alpha antagonists (see MOP).
15. Use of surgical debridement and/or xenograft.
16. Known positive SARS-CoV-2 on RT-PCR within 10 days prior to screening or within 5 days of admission or symptomatic COVID-19 infection at screening. Symptomatic patients with a positive SARS-CoV-2 on RT-PCR or comparable assay beyond 10 days must be evaluated by the Independent Protocol Monitor.
17. Clinical or radiographic evidence of active tuberculosis or endemic mycoses.
18. History or evidence of any other clinically significant medical or psychiatric disorder, condition or disease that in the opinion of the treating physician would pose a risk or interfere with evaluation or completion of the study such as known sepsis/systemic infection requiring antibiotic therapy.
19. Known hypersensitivity to Enbrel® (etanercept).
20. Receipt of a live attenuated vaccine within 30 days of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02987257
Study Brief:
Protocol Section:
NCT02987257