A randomized, double-blind, placebo-controlled study of patients with PV using Infliximab

The purpose of this trial is to determine the safety of infliximab (Remicade) for the treatment of patients with pemphigus vulgaris. Secondary clinical endpoints include the number of days to cessation of new blister formation, the ability to reduce prednisone to 25% of the initial dose by week 18.

Background

The Divisions of Dermatology at Duke University Medical Center, University of Pennsylvania School of Medicine, Medical College of Wisconsin, and Florida Academic Dermatology Centers are recruiting patients for a clinical study using infliximab (Remicade) to treat patients with pemphigus vulgaris who continue to have blisters, skin ulcers or other disease activity despite therapy with 20 mg/day or more of prednisone therapy. 20 patients will be treated with intravenous infusions of infliximab or placebo on weeks 0, 2, 6, 14 followed by monthly follow up visits through week 26.

Purpose of Trial

The purpose of this trial is to determine the safety of infliximab for the treatment of patients with pemphigus vulgaris. Secondary clinical endpoints include the number of days to cessation of new blister formation, the ability to reduce prednisone to 25% of the initial dose by week 18.

Enrollment Criteria

Patients must be at least 18 years of age with a clinical diagnosis of pemphigus vulgaris and ongoing disease activity and on 20 mg/day or more of prednisone. Patients that are taking other immunosuppressive drugs such as azathioprine (Imuran), mycophenolate mofetil (Cellcept), methotrexate, or cyclosporine A will undergo a 4-week washout phase before beginning the trial. Pregnant or nursing women are not eligible to participate in the trial. All potential participants will have a screening visit which will include a review of their medical history, physical examination and obtaining of a blood sample to determine their eligibility to participate in the study.

Contact Information

Please contact the Division of Dermatology at any of the following locations closest to you by email or phone with questions regarding this trial and feel free to pass on this contact information to all interested individuals.

Locations

Duke University Medical Center: University of Pennsylvania:
Durham, NC Philadelphia, PA

Principal Investigator: Principal Investigator:
Russell P. Hall III M.D. Victoria Werth., MD
919-684-3110 215-823-4208
Russell.Hall@Duke.edu werth@mail.med.upenn.edu

Clinical Trial Coordinator: Clinical Trial Coordinator:
Deborah Hannah Joyce Okawa
919-681-5797 215-823-4439
Deborah.Hannah@Duke.edu joyce.okawa@uphs.upenn.edu

Clinical Trial Coordinator: Clinical Trial Coordinator:
Marge Wolkimir Annika Grant
414-805-5313 305-324-2110×104
mwolkomi@mcw.edu annikagrant@bellsouth.net