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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Florida Academic Dermatology Centers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier:
NCT00797784
First received: November 21, 2008
Last updated: May 25, 2010
Last verified: November 2008
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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: April 2011
Estimated Primary Completion Date: April 2011 (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

No publications provided

Responsible Party: Francisco A Kerdel,M.D., Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier: NCT00797784     History of Changes
Other Study ID Numbers: FADC
Study First Received: November 21, 2008
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Immunoglobulin G
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014