NCT00797784

UnknownPhase 2

The Safety and Efficacy of Etanercept (Enbrel®) for the Trea...

Florida Academic Dermatology Centers Source

Florida Academic Dermatology Centers

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

FADC

Study Type

interventional

Estimated enrollment

20

Locations

1 country

Sites

1

Timeline

Study Start

October 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

April 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 20 participants
Study completion date: April 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 21, 2008
Actual (reported)
First Posted
November 25, 2008
Actual (reported)
Primary Completion
April 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: May 26, 2010
Status Verified: November 2008
Last Update Submitted: 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;

Sponsors & Collaborators

Florida Academic Dermatology Centers
Otherlead

Study Sites (1)

Florida Academic Dermatology Centers

Miami, Florida, 33136, United States

RECRUITING

Annika M Grant, RN,MBACONTACT305-324-2110 ext. 210 annika@fadcenter.com

Francisco A Kerdel, M.D.PRINCIPAL INVESTIGATOR

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 Regions

Central Study Contacts

Annika M Grant, RN, MBA

CONTACT

305 324 2110 annika@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 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2011

Estimated (date passed)

NCT00625521

Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions

Phase 2Completed

NCT00625157

Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)

Phase 2Completed

NCT03958955

Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

Phase 2Terminated

NCT06261021

Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

Phase 2Recruiting

NCT07557927

A Multicentre, Randomised, Double-blind, Positive-control Clinical Trial Evaluating Dihydroartemisinin Tablets for the Treatment of Discoid Lupus Erythematosus

Phase 2Not Yet Recruiting

NCT01989689

Etanercept and Vascular Function in Psoriasis

Phase 2Completed

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.

Immunoglobulins

Immunoproteins

Blood Proteins

Proteins

Serum Globulins

Globulins

Receptors, Tumor Necrosis Factor

Receptors, Cytokine

Receptors, Immunologic

Receptors, Cell Surface

Membrane Proteins

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

April 2011

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

May 26, 2010

Record last verified: 2008-11

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00797784
Data provider: ClinicalTrials.gov
Source updated: 2010-05-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:46 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations