The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus (DISCLUP2008)

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. Identifier: NCT00797784
Recruitment Status : Unknown
Verified November 2008 by Florida Academic Dermatology Centers.
Recruitment status was:  Recruiting
First Posted : November 25, 2008
Last Update Posted : May 26, 2010
Information provided by:
Florida Academic Dermatology Centers

Brief Summary:
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus

Condition or disease Intervention/treatment Phase
Discoid Lupus Erythematosus (DLE) Drug: etanercept(Enbrel®) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus
Study Start Date : October 2008
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Etanercept

Intervention Details:
  • Drug: etanercept(Enbrel®)
    etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements [ Time Frame: 20 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.


  • 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.

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00797784

Contact: Annika M Grant, RN, MBA 305 324 2110 ext 210

United States, Florida
Florida Academic Dermatology Centers Recruiting
Miami, Florida, United States, 33136
Contact: Annika M Grant, RN,MBA    305-324-2110 ext 210   
Principal Investigator: Francisco A Kerdel, M.D.         
Sponsors and Collaborators
Florida Academic Dermatology Centers

Responsible Party: Francisco A Kerdel,M.D., Florida Academic Dermatology Centers Identifier: NCT00797784     History of Changes
Other Study ID Numbers: FADC
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: November 2008

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Cutaneous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors