Discoid Lupus Erythematosus (DLE)Phase 2DISCLUP2008NCT00797784
The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus
A Phase 2 study testing etanercept(Enbrel®) in people with Discoid Lupus Erythematosus (DLE), run by Florida Academic Dermatology Centers at 1 site in United States.
Trial summary
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoid Lupus Erythematosus (DLE)
- What is being tested?
- etanercept(Enbrel®)
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Apr 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with discoid lupus erythematosus .Subjects require to have confirmation of diagnosis by a skin biopsy .This can be undertaken at the screening visit if no previous biopsy confirmation available.
- And;
- Having failed steroids (topical, intralesional, systemic) and are candidates for antimalarial therapy
- Negative ANA
- Have no history of latent or active TB prior to screening.
Who cannot join
- Subjects allergic to sunscreens
- Prior treatment with anti-TNF therapies
- Subjects who do not have a previous skin biopsy result confirming a DLE diagnosis and who are unwilling to undergo this procedure at screening.
- Subjects currently receiving systemic steroid therapy (or have received in the last 3 months)
- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
- Prior or concurrent use of cyclophosphamide therapy
Show all 12Show fewer
- Concurrent sulfasalazine therapy.
- Known HIV-positive status or known history of any other immuno-suppressing disease.
- Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication
- Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.
- Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer])
- Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Florida Academic Dermatology Centers
Miami, Florida, 33136
Annika M Grant, RN,MBA, 305-324-2110 ext. 210, annika@fadcenter.com
Francisco A Kerdel, M.D.
About this study
Official title: A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus
- Conditions
- Discoid Lupus Erythematosus (DLE)
- Being tested
- etanercept(Enbrel®)
- Medical subject headings
- Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanercept(Enbrel®)Drug
etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients responding to study treatment using the Cutaneous Lupus Erythematous Disease Area Severity Index(CLASI)defined as a decrease of 50% form baseline.
Measured: 20 weeks
Secondary outcomes (1)
Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoid Lupus Erythematosus (DLE)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Academic Dermatology Centers
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797784
- Sponsor's protocol ID
- FADC
- Acronym
- DISCLUP2008
- Status last verified
- Nov 2008
- First submitted
- 21 Nov 2008
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00797784
- Acronym / sponsor ID
- DISCLUP2008 / FADC
- Conditions
- Discoid Lupus Erythematosus (DLE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Florida Academic Dermatology CentersUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 25 Nov 2008 (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.
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with discoid lupus erythematosus .Subjects require to have confirmation of diagnosis by a skin biopsy .This can be undertaken at the screening visit if no previous biopsy confirmation available.
- And;
- Having failed steroids (topical, intralesional, systemic) and are candidates for antimalarial therapy
- Negative ANA
- Have no history of latent or active TB prior to screening.
Key exclusion criteria (12 listed)
- Subjects allergic to sunscreens
- Prior treatment with anti-TNF therapies
- Subjects who do not have a previous skin biopsy result confirming a DLE diagnosis and who are unwilling to undergo this procedure at screening.
- Subjects currently receiving systemic steroid therapy (or have received in the last 3 months)
- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
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 |
|---|---|---|
| etanercept(Enbrel®)etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks | Drug | – |
Primary outcome
Proportion of patients responding to study treatment using the Cutaneous Lupus Erythematous Disease Area Severity Index(CLASI)defined as a decrease of 50% form baseline.
Time frame: 20 weeks
1 secondary outcome
Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etanercept(Enbrel®) in people with Discoid Lupus Erythematosus (DLE), run by Florida Academic Dermatology Centers at 1 site in United States.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annika M Grant, RN, MBA (305 324 2110 ext. 210, annika@fadcenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients responding to study treatment using the Cutaneous Lupus Erythematous Disease Area Severity Index(CLASI)defined as a decrease of 50% form baseline. (time frame: 20 weeks). 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 May 2010.