Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
Recruitment status was Recruiting
Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%). Hypersensitivity syndrome, sometimes called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), has a mortality rate evaluated at about 10%. The aims of this project are (1) to compare the effect of treatment between systemic steroid and anti-TNF α. Including skin re-epithelization time, internal organ recovery time, mortality rate, and (2) to investigate the pathogenesis of severe cutaneous adverse reaction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions (SCAR)|
- skin and mucosa membrane healing time [ Time Frame: one years ] [ Designated as safety issue: No ]Lab exams and "GLOBAL ASSESSMENT OF EFFICACY" will be done on the diagnosis is confirmed, before drugs are given and one month after treatment is complete.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: anti- TNF-a, SCAR, treatment
Drug: anti-TNF a
25mg BIW, SC
Other Name: Etanercept
Severe cutaneous adverse drug reactions, including Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome(SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)is a life threatening disease. There is no gold standard in the therapy of SCAR. Treatment with highdose systemic glucocorticoids is controversial. Although there have been recent reports of success with various therapies such as plasmapheresis and high-dose intravenous immunoglobulins, their efficacy is not yet proven. Assessment of these therapies is difficult because of their non-specific immunosuppressant or immunomodulating modes of action. Recent studies have shown evidence of the pathogenetic importance of tumour necrosis factor (TNF)-a,6 suggesting a new therapeutic approach in selective blockade of TNF-a using specific antibodies. We report successful treatment TEN using monoclonal IgG anti-TNF-antibodies. The aims of this project are (1) to compare the effect of treatment between systemic steroid and anti-TNF α. Including skin re-epithelization time, internal organ recovery time, mortality rate. (2) to investigate the pathogenesis of severe cutaneous adverse reaction. This is a open-label, prospective, randomized, control study. Total 90 SCAR patients are collected.
Including criteria: Patients are diagnosed with SCAR, including SJS, TEN, DRESS. And the age of patient are above 18 year-old. Exclusive criteria: pregnancy or breast-feeding women, allergy to anti-TNF-α agent before, active tuberculosis, active infection systemic disease, active HBV or HCV hepatitis, immunocompromise patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276314
|Contact: Wen-Hung Chung, MD||886-2-2713-5211 ext firstname.lastname@example.org|
|Department of Dermatology, Chang Gung Memorial hospital||Recruiting|
|Taipei, Taiwan, 105|
|Contact: Wen-Hung Chung, MD 886-2-2713-5211 ext 3397 email@example.com|
|Study Chair:||Wen-Hung Chung, MD||Department of Dermatology, CGMH|