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The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus (DISCLUP2008)
This study is currently recruiting participants.
Verified by Florida Academic Dermatology Centers, November 2008
Sponsored by: Florida Academic Dermatology Centers
Information provided by: Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier: NCT00797784
  Purpose

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


Condition Intervention Phase
Discoid Lupus Erythematosus (DLE)
Drug: etanercept(Enbrel®)
Phase II

MedlinePlus related topics: Lupus
Drug Information available for: Etanercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy 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

Further study details as provided by Florida Academic Dermatology Centers:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: etanercept(Enbrel®)
    etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797784

Contacts
Contact: Annika M Grant, RN, MBA 305 324 2110 ext 210 annika@fadcenter.com

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

Responsible Party: Florida Academic Dermatology Centers ( Francisco A Kerdel,M.D. )
Study ID Numbers: FADC
Study First Received: November 21, 2008
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00797784  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies
Autoimmune Diseases
Skin Diseases
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Immunoglobulin G
Connective Tissue Diseases
TNFR-Fc fusion protein
Lupus Erythematosus, Discoid
Immunoglobulins
Cutaneous lupus erythematosus

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009