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.
Background
The Divisions of Dermatology at Duke University Medical Center, University of Pennsylvania School of Medicine, University of Iowa, and the University of Southern California 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.
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
Durham, NC
Principal Investigator
Russell P. Hall III M.D.
919-684-3110
Clinical Trial Coordinator
Deborah Hannah
919-681-5797
Deborah.Hannah@Duke.edu
