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Immunosuppressant
Etanercept vs Cyclosporine for Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (NATIENS Trial)
Phase 3
Recruiting
Led By Elizabeth J Phillips, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of disease progression with an increasing number of skin lesions
Mucous membrane involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year or study outcome
Awards & highlights
NATIENS Trial Summary
This trial is testing whether two therapeutic interventions (etanercept vs cyclosporine) are better than supportive care alone for treating Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
Who is the study for?
Adults over 18 with Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, showing skin and mucous membrane symptoms, fever, muscle pain, headache, and a recent history of medication intolerance. Pregnant or breastfeeding women and those with certain medical conditions or treatments are excluded.Check my eligibility
What is being tested?
The NATIENS study is testing whether cyclosporine (for 14 days) or etanercept (two doses) alongside standard care improves recovery from SJS/TEN compared to standard care alone. It's a phase III trial involving multiple U.S. centers where patients are randomly assigned to one of the three groups in a blinded manner.See study design
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk, possible liver and kidney issues due to cyclosporine, injection site reactions from etanercept, allergic reactions if sensitive to either drug's components.
NATIENS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin cancer is getting worse with more lesions.
Select...
My condition affects the moist tissues of my body.
Select...
I am older than 18 years.
NATIENS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year or study outcome
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year or study outcome
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to complete re-epithelialization
Secondary outcome measures
Hospital length of stay
Infections
Mortality
+3 moreOther outcome measures
Cyclosporine levels
Granulysin, IL-15 and other cytokine measurements
NATIENS Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Cyclosporine 5mg/kg bid days 0-14Active Control2 Interventions
Harmonized supportive care with placebo etanercept days 0 and 3
Group II: Etanercept 50mg sc day 0 and day 3Active Control2 Interventions
Harmonized supportive care with placebo cyclosporine days 0-14
Group III: Harmonized supportive carePlacebo Group1 Intervention
Harmonized supportive care with placebo cyclosporine days 0-14 and etanercept placebo days 0 and 3
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
671,930 Total Patients Enrolled
University of OttawaOTHER
207 Previous Clinical Trials
266,874 Total Patients Enrolled
University of TorontoOTHER
690 Previous Clinical Trials
1,019,376 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion means that the participant needs to meet at least two of the following conditions.You have a severe reaction to a drug, or a skin condition that is not related to a drug reaction.If more than 5 days have passed since you first noticed skin or mouth problems.I am allergic to Sandimmune or Cremophor EL.You are allergic to Enbrel® (etanercept).I have not received a live vaccine in the last 30 days.I have had symptoms like fever, muscle pain, and headaches recently.My skin cancer is getting worse with more lesions.I have taken etanercept or cyclosporine in the past 6 months.I am on dialysis.I haven't taken strong immune system affecting drugs that could interfere with the treatment.I have had surgery to remove damaged tissue or used a graft from another species.I do not have active tuberculosis or fungal infections.I have red to dark spots on my trunk that may be merging or causing skin peeling.You have tested positive for COVID-19 within the last 10 days, or within 5 days of admission, or have symptoms of COVID-19 at the time of screening. If you have symptoms and a positive test beyond 10 days, a special monitor will check your situation.I have had an organ transplant.I have Multiple Sclerosis or a similar condition.I recently started a new medication that I couldn't tolerate for more than 12 weeks.I have chronic kidney disease with an eGFR less than 30.I must take a medication that interacts with cyclosporine and cannot be replaced.I have severe heart failure.I am of childbearing age and have a negative pregnancy test.I have received immune therapy for my cancer.My condition affects the moist tissues of my body.I have received IV immune treatment or more than 2 high-dose steroid treatments for my SJS/TEN.You have moderate to severe liver problems, as indicated by specific blood test results.I am older than 18 years.My liver is severely damaged.
Research Study Groups:
This trial has the following groups:- Group 1: Cyclosporine 5mg/kg bid days 0-14
- Group 2: Etanercept 50mg sc day 0 and day 3
- Group 3: Harmonized supportive care
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new volunteers currently being sought for this experiment?
"Unfortunately, the most recent information on clinicaltrials.gov suggests that this particular trial is not presently looking for patients. Although it is no longer enrolling participants, there are 1555 other trials currently underway that may be of interest."
Answered by AI
What are the primary benefits of Cyclosporine 5mg/kg bid days 0-14?
"Cyclosporine, taken twice a day at a dosage of 5mg per kilogram body weight for the first two weeks, can be used to ameliorate transplantation, lupus nephritis, and excessive tearing."
Answered by AI
Has the FDA given their blessing to Cyclosporine 5mg/kg being administered twice a day for the first two weeks?
"Cyclosporine 5mg/kg bid days 0-14 is safe according to our estimation, which falls on a scale of 1-3. This medication is in Phase 3 trials, so there is some data supporting efficacy as well as multiple rounds of safety testing."
Answered by AI
How many people are being given the chance to participate in this test?
"This particular clinical trial is no longer recruiting patients. The study was initially posted on November 30th, 2020 and the last update was October 31st, 2020. However, there are currently 1451 other trials actively looking for patients with stevens-johnson syndrome and 104 trials for Cyclosporine 5mg/kg bid days 0-14 that are still enrolling participants."
Answered by AI
Is there a history of research using Cyclosporine 5mg/kg bid days 0-14?
"Currently, there are 104 active clinical trials investigating the efficacy of Cyclosporine 5mg/kg bid days 0-14. Of these studies, 22 are in Phase 3. Although most of the research is conducted in Xi'an, Shaanxi, there are 1135 locations around the world where these studies are taking place."
Answered by AI
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