Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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 life threatening blistering condition that currently has no cure.

An investigational drug is one that has not been approved by the United States (US) Food and Drug Administration (FDA) to treat a particular condition or disease. Etanercept has been approved by the FDA to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and psoriasis, but not pemphigus vulgaris.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; Stanford University
• Treatments: Etanercept

Criteria

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