Thank you for your interest in the pemphigus vulgaris study.

The purpose of this study is to examine the ability of etanercept to produce improvement in pemphigus vulgaris, to allow for reduction of baseline prednisone dose, and to evaluate the safety of etanercept when given to patients with pemphigus vulgaris. You will be able to continue your current medications for pemphigus throughout the trial, and you will be compensated $200 for your completion of the trial. This drug is generally well-tolerated in trials to date, with a very common side effect being a reaction at the site of the injection, consisting of redness, pain, swelling, or itching.

Before starting the study, you will have a screening visit, which will include a physical exam and a review of your medical history and a blood draw, to determine if you are eligible to enroll in the study. All participants must be at least 18 years of age with a clinical diagnosis of pemphigus vulgaris and at least 6 active blisters or erosions. Neither pregnant nor nursing women will be included in the study.

If you are eligible, you will return for future visits at 0, 2, 4, 8, and 16 weeks, with the option to withdraw from the study at any time. You will be randomly assigned (by chance) to receive either etanercept or placebo subcutaneously (injected under the skin) once a week (by you or someone of your choice who we will train). If you do well and are also taking steroids, your current dose of steroids will be tapered. The entire study will be “blinded”, meaning that neither you nor the evaluating physician will know whether you are receiving the drug or the placebo.

Please contact us by e-mail or phone with any questions you may have and to schedule a screening appointment, if interested.

Dermatology Joint Clinical Trials Unit
Massachusetts General Hospital (617-726-1660)
Brigham and Women’s Hospital (617-525-7975)
harvardskinstudies@partners.org