NCT00797784

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 26, 2010

Status Verified

November 1, 2008

Enrollment Period

2.5 years

First QC Date

November 21, 2008

Last Update Submit

May 25, 2010

Conditions

Discoid Lupus Erythematosus (DLE)

Outcome Measures

Primary Outcomes (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.

    20 weeks

Secondary Outcomes (1)

  • Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements

    20 weeks

Interventions

etanercept(Enbrel®)DRUG

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Academic Dermatology Centers

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Lupus Erythematosus, CutaneousConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Central Study Contacts

Annika M Grant, RN, MBA

CONTACT

305 324 2110annika@fadcenter.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 25, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 26, 2010

Record last verified: 2008-11

Locations

US(1)