ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01276314
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

July 5, 2009
January 13, 2011
November 3, 2017
December 19, 2017
December 19, 2017
January 2009
May 2015   (Final data collection date for primary outcome measure)
Skin Healing Time [ Time Frame: One to two months for SJS/TEN cases, and one to six months for DRESS cases. ]
Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.
skin and mucosa membrane healing time [ Time Frame: one years ]
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.
Complete list of historical versions of study NCT01276314 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions (SCAR)
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 healing time, beginning of re-epithelialization time, internal organ recovery time, mortality rate, adverse events and (2) to investigate the molecular mechanism of severe cutaneous adverse reaction after anti-TNF-α treatment.
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 high dose systemic corticosteroids 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, 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 healing time, beginning of re-epithelialization time, internal organ recovery time, mortality rate, adverse events and (2) to investigate the molecular mechanism of severe cutaneous adverse reaction after anti-TNF-α treatment.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug Hypersensitivity
  • Drug: anti- TNF-a
    25mg BIW, SC
    Other Name: Etanercept
  • Drug: Prednisolone
    1-1.5 mg / kg / day
    Other Name: steroid therapy
  • Experimental: anti- TNF-a treatment
    1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF
    2. Fill out the case report form
    3. Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis
    4. Etanercept administration:

    The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks

    Intervention: Drug: anti- TNF-a
  • Active Comparator: control group
    1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF
    2. Fill out the case report form
    3. Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis
    4. Drug administration:

    The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose.

    Intervention: Drug: Prednisolone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
90
May 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patient with clinical and pathological diagnoses of severe cutaneous adverse drug reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or Durg reaction with eosinophilia and systemic symptoms.
  2. Male or female patient aged more than 4 years.
  3. Inform consent obtained.

Exclusion Criteria:

  1. Pregnant or breastfeeding female.
  2. Allergic to any anti-TNF-α biological product.
  3. Active or latent tuberculosis confirmed with Chest X-ray.
  4. Severe active infection and septicemia.
  5. Active Hepatitis B or C carrier.
  6. Suspected HIV carrier with CD4 count less than 200.
  7. Patient with poor compliance or with safety concerns judged by investigator.
Sexes Eligible for Study: All
4 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01276314
97-1413A3
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
National Science Council, Taiwan
Study Chair: Wen-Hung Chung, MD Department of Dermatology, CGMH
Chang Gung Memorial Hospital
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP