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Glucocorticoids combined with tumor necrosis factor inhibitors in the treatment of immune-related epidermal necrolysis

Glucocorticoids combined with biologics in the treatment of severe immune-related adverse events: glucocorticoids combined with tumor necrosis factor inhibitors in the treatment of immune-related epidermal necrolysis, a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070188
Enrollment
Unknown
Registered
2023-04-04
Start date
2023-04-07
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

epidermal necrolysis

Interventions

corticosteroid:methylprednisolone
tumor necrosis factor inhibitors:methylprednisolone with adalimumab or infliximab

Sponsors

Pekin Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) aged 18-75 years; 2) pathologically confirmed solid tumor/hematological malignancy; 3) initially received immune checkpoint inhibitors with or without chemotherapy; 4) clinically diagnosed as immune-related epidermal necrolysis; 5) provided with written informed consent

Exclusion criteria

Exclusion criteria: 1) patients with active tuberculosis; 2) patients with uncontrolled serious and active infection; 3) patients with moderate to severe heart failure (NYHA grade III/IV); 4) patients combined with grade 3 drug-induced liver injury; 5) patients allergic to adalimumab or infliximab; 6) pregnant women; 7) patients with poor compliance or not suitable to be included in this study judged by the investigator.

Design outcomes

Primary

MeasureTime frame
skin healing time;—

Secondary

MeasureTime frame
disease control time;mortality rate in acute phase;cumulative doses of corticosteroid;length of stay in hospital;incidence ofsepsis;incidence of pneumonia;adverse events of special interest;—

Countries

China

Contacts

Public ContactMeng-Zhao Wang

Peking Union Medical College Hospital

mengzhaowang@sina.com18610929156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026