Recruiting
Phase 2

Etanercept

Sponsor:

Florida Academic Dermatology Centers

Code:

NCT00797784

Conditions

Discoid Lupus Erythematosus (DLE)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

etanercept(Enbrel®)

Study Details

Brief summary:

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)

Study ID

NCT00797784

Start date

Oct, 2008

Status verified date

Nov, 2008

Completion date

Apr, 2011

Anticipated

Primary completion date

Apr, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

etanercept(Enbrel®)

etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks

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 ]

Central Contacts and Locations

Central contacts

Annika M Grant, RN, MBA

305 324 2110annika@fadcenter.com

Locations

Florida Academic Dermatology Centers

Recruiting

Miami, Florida, United States, 33136

Contacts

Annika M Grant, RN,MBA

305-324-2110annika@fadcenter.com

Principal Investigator:

Francisco A Kerdel, M.D.

More Information

Sponsor

Florida Academic Dermatology Centers

Last update posted

May 26, 2010

Last verified

Nov, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida Academic Dermatology Centers on 2010-05-26.