Toxic Epidermal NecrolysisPhase 2NCT00372723
Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)
A Phase 2 study testing Remicaide (infliximab) in people with Toxic Epidermal Necrolysis, run by Loyola University.
Trial summary
To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toxic Epidermal Necrolysis
- What is being tested?
- Remicaide (infliximab)
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to burn unit with a histologic diagnosis of TENs
Who cannot join
- Pregnancy
- hypersensitivity to remicaide
- history of heart failure
- documented bacteremia
- history of cancer
- inability to consent
About this study
Official title: Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.
Read the detailed description
This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.
- Conditions
- Toxic Epidermal Necrolysis
- Being tested
- Remicaide (infliximab)
- Keywords
- toxic epidermal necrlysis, ten
- Medical subject headings
- Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remicaide (infliximab)Drug
a single dose infusion of 5mg/kg Remicade (Infliximab)
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
Measured: 30 days
Secondary outcomes (1)
Safety labs and adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxic Epidermal NecrolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Gamelli, MD, Principal investigator, Loyola University Medical Center, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372723
- Sponsor's protocol ID
- 108983
- Status last verified
- Apr 2013
- First submitted
- 5 Sep 2006
- Last updated
- 26 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
- ClinicalTrials.gov ID
- NCT00372723
- Acronym / sponsor ID
- 108983
- Conditions
- Toxic Epidermal Necrolysis
- Keywords
- toxic epidermal necrlysis, ten
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.
Detailed description
This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to burn unit with a histologic diagnosis of TENs
Key exclusion criteria (6 listed)
- Pregnancy
- hypersensitivity to remicaide
- history of heart failure
- documented bacteremia
- history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remicaide (infliximab)a single dose infusion of 5mg/kg Remicade (Infliximab) | Drug | – |
Primary outcome
30 day mortality
Time frame: 30 days
1 secondary outcome
Safety labs and adverse events
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Gamelli, MD principal investigator
Loyola University Medical Center, Department of Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remicaide (infliximab) in people with Toxic Epidermal Necrolysis, run by Loyola University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.