Drug Hypersensitivity Clinical Trial
Official title:
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02839551 -
Optimal Doses for Drug Provocation Tests to Beta-lactams
|
N/A | |
| Completed |
NCT00198419 -
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
|
Phase 1 | |
| Completed |
NCT02839811 -
Medical Device for Drug Allergy Diagnosis
|
N/A | |
| Completed |
NCT02983630 -
Allergy Testing of Patients Labeled as Penicillin Allergic
|
N/A | |
| Completed |
NCT00198458 -
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
|
Phase 1 | |
| Recruiting |
NCT04330118 -
Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
|
||
| Completed |
NCT04421638 -
Cephalosporin Hypersensitivity
|
||
| Recruiting |
NCT02031120 -
Management of Drug Hypersensitivity in Children
|
N/A | |
| Terminated |
NCT00505648 -
Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)
|
Phase 3 | |
| Completed |
NCT03158831 -
Drug Challenges Without Prior Skin Testing
|
Phase 1 | |
| Completed |
NCT03076749 -
Predictive Models for Betalactam Allergy
|
N/A | |
| Active, not recruiting |
NCT06428162 -
An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community
|
||
| Terminated |
NCT02844712 -
Negative Predictive Value of Drug Provocation Tests to Beta-lactams
|
N/A | |
| Completed |
NCT03771118 -
Drug Provocation Test (DPT) to Paracetamol
|
||
| Completed |
NCT03743220 -
Drug Provocation Test (DPT) to Non Steroidal Anti-inflammatory Drugs (NSAID)
|
||
| Not yet recruiting |
NCT06406114 -
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
|
Phase 2 | |
| Completed |
NCT05269082 -
A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
|
||
| Completed |
NCT04827602 -
Drug Allergy Labels After Drug Allergy Investigation
|