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Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01276314
First received: July 5, 2009
Last updated: January 11, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention
Drug Hypersensitivity
Drug: anti-TNF a

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 90
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)
Arms Assigned Interventions
Experimental: anti- TNF-a, SCAR, treatment
  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.
Drug: anti-TNF a
25mg BIW, SC
Other Name: Etanercept

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients are diagnosed with SCAR, including SJS, TEN, DRESS
  • age of patients are above 18 years old

Exclusion Criteria:

  • pregnancy or breast-feeding women
  • allergy to anti-TNF-α agent before
  • active tuberculosis now
  • active infection systemic disease now
  • active HBV or HCV hepatitis now
  • immunocompromised patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276314

Contacts
Contact: Wen-Hung Chung, MD 886-2-2713-5211 ext 3397 wenhungchung@yahoo.com

Locations
Taiwan
Department of Dermatology, Chang Gung Memorial hospital Recruiting
Taipei, Taiwan, 105
Contact: Wen-Hung Chung, MD    886-2-2713-5211 ext 3397    wenhungchung@yahoo.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
Study Chair: Wen-Hung Chung, MD Department of Dermatology, CGMH
  More Information

Publications:
Responsible Party: Wen-Hung Chung, Department of Dermatology, CGMH
ClinicalTrials.gov Identifier: NCT01276314     History of Changes
Other Study ID Numbers: 97-1413A3
Study First Received: July 5, 2009
Last Updated: January 11, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
SCAR
anti-TNF-a

Additional relevant MeSH terms:
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Hypersensitivity
Chemically-Induced Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2014