Status:
COMPLETED
Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
Stanford University
Conditions:
Pemphigus Vulgaris
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to find out about the effectiveness and the safety of an investigational drug called etanercept (Enbrel) to treat pemphigus vulgaris. Pemphigus vulgaris is a potentially li...
Detailed Description
People with pemphigus vulgaris have been found to have an increased amount of a substance called tumor-necrosis factor-alpha (TNF-alpha) in their blood. Etanercept may control pemphigus vulgaris by bl...
Eligibility Criteria
Inclusion
- Summary Inclusion Criteria:
- Understand and sign the written informed consent form and be willing and able to comply with the procedures of the study
- Have a clinical diagnosis of pemphigus vulgaris
- Have at least 6 active pemphigus lesions (blisters or erosions)
- Have no adverse effects due to combining etanercept with concurrent pemphigus medications
- Be on stable dose of current pemphigus medications for at least one month
- Females of child-bearing potential must have a negative urine pregnancy test prior to treatment and agree to practice an acceptable method of birth control (oral contraceptives, hormonal implant devices, Depo-Provera, condom with spermicide, diaphragm with contraceptive cream or foam, or intrauterine device) during the course of the study
- Be at least 18 years old at time of enrollment
- Be able to adhere to the study visit schedule and other protocol requirements
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00135720
Start Date
June 1 2004
End Date
November 1 2007
Last Update
June 3 2015
Active Locations (1)
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1
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114