The purpose of this trial is to determine the safety of rituximab for the treatment of bullous pemphigoid. 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 24 and bullous pemphigoid antibody levels at week 24.
Background
The Division of Dermatology at Duke University Medical Center is recruiting patients for a clinical study using rituximab (Rituxan) to study the treatment of bullous pemphigoid in participants who continue to have blisters, skin ulcers or other disease activity despite therapy with 17.5 mg/day or more of prednisone therapy. 8 participants will be treated with intravenous infusions of rituximab on day 1 and day 15 and followed monthly for 6 months and then every 3 months for a total of 1 year.
Enrollment Criteria
Participants must be at least 18 years of age with a clinical diagnosis of bullous pemphigoid and ongoing disease activity and on 17.5 mg/day or more of prednisone. Participants 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 Duke University Medical Center by email or phone with questions regarding this trial and feel free to pass on this contact information to all interested individuals.
Principal Investigator
Russell P. Hall III M.D.
J. Lamar Callaway Professor and Chief
Division of Dermatology
Department of Medicine
Duke University School of Medicine
919-684-3110 (phone)
919-684-3002 (FAX)
Russell.Hall@Duke.edu
Clinical Trial Coordinator
Deborah Hannah
919-681-5797 (phone)
919-684-3002 (FAX)
Deborah.Hannah@Duke.edu
