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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210325

Registered date:17/09/2021

Etanercept therapy for Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) cases of refractory to systemic steroid therapy

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedstevens-johnson syndrome, toxic epidermal necrosis
Date of first enrollment01/10/2021
Target sample size10
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Etanercept 50 mg / day is subcutaneously administered on the first day (Day 1). If epithelialization is not complete, administer once on day 8 (Day 8) and day 15 (Day 15) as needed.

Outcome(s)

Primary OutcomePeriod until re-epithelialization is completed (day) The number of days from the first administration day (Day 1) to the completion date of re-epithelialization when the skin peeling area becomes 0% is totaled and evaluated.
Secondary Outcome1. Period until the progress of skin symptoms stops (day) The progress of the skin symptoms stop from the first day of administration (Day 1) to aggregate the number of days until the (new blisters / skin peeling, flaking and state not recognized is likely to skin) evaluation. 2. Hospitalization period (day) The number of days from Day 1 to the discharge date is totaled and evaluated. 3. Mortality rate until Day 29 Aggregate the deaths from Day 1 to Day 29 and evaluate the mortality rate. 4. Severity-of-illness evaluation The severity-of-illness score at each evaluation point and amount of change from baseline for each item are evaluated. 5. Corneal epithelial defect score Evaluate the amount of change from baseline. 6. Presence or absence of re-epithelialization The presence or absence of re-epithelialization is confirmed every week, and the re-epithelialization rate is evaluated.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patients who meet the SJS diagnostic criteria or the TEN diagnostic criteria. 2.Patients treated with systemic steroid therapy (predonisolone equivalent administrated 20 mg/day or more) for 2 days or more. 3. Patients with progressing or unchanged symptoms after steroid therapy. 4. Patients aged 20 years or older who gave written consent to participate in the study.
Exclude criteria1. Patients whose dose of systemic steroid therapy has been changed within 2 days (excluding cases where dose reduction is necessary due to worsening complications, etc.) 2. Patients who received steroid pulse therapy within 2 days 3. Patients who received IVIg therapy within 2 days 4. Patients who received plasma exchange therapy within 2 days 5. Patients who need to use the concomitant prohibited drugs and therapies in this study 6. Patients with a total SCORTEN score of 4 points or more 7. Patients with DIHS 8. Patients with multiple organ failure 9. Patients with serious infection and sepsis 10. Patients with demyelinating disease (multiple sclerosis, etc.) 11. Patients with serious respiratory illness (active or latent tuberculosis, etc. ) 12. Patients infected with hepatitis B virus or hepatitis C virus 13. Patients with severe cerebral and cardiovascular disorders 14. Patients with severe deterioration of cardiac function 15. Patients at high risk of thrombosis embolus 16. Patients with hemolytic and blood loss anemia 17. Patients with platelet count less than 75,000 /microL 18. Patients with serum creatinine of 2 mg/dL or more 19. Patients with a history of shock and hypersensitivity to ETN 20. Patients who have been treated with ETN or other TNF-alpha inhibitors within 168 days ( 24 weeks ) 21. Patients treated with other unapproved drugs within 168 days ( 24 weeks ) 22. Pregnant, expected pregnant, lactating patients, or patients who disagree with contraception until the end of observation 23. Patients who are judged to be inappropriate by the responsible doctor or the sharing doctor

Related Information

Contact

Public contact
Name Mahoko Oginezawa
Address 1-754 Asahimachi-dori, Chuo-ku Niigata 951-8510, Japan Niigata Japan 951-8510
Telephone +81-25-227-2282
E-mail mahoko.sakaue@gmail.com
Affiliation Niigata University Medical and Dental Hosipotal
Scientific contact
Name Riichirou Abe
Address 1-754 Asahimachi-dori, Chuo-ku Niigata 951-8510, Japan Niigata Japan 951-8510
Telephone +81-25-227-2282
E-mail aberi@med.niigata-u.ac.jp
Affiliation Niigata University Medical and Dental Hosipotal