This study will determine if infliximab given in combination with prednisone is a safe and effective treatment for adults with PV.

PV involves blistering of the outer layer of skin and mucous membranes, causing a separation of epidermal cells. The disease occurs when the immune system produces antibodies to specific proteins in the skin and mucous membranes; the cause for production of these autoantibodies is unknown. Infliximab is a genetically engineered monoclonal antibody directed against tumor necrosis factor (TNF)-alpha, a chemical messenger that activates an immune response. Infliximab has been used to treat other autoimmune disorders, including rheumatoid arthritis, ankylosing spondylitis, and Crohn’s disease. This study will evaluate the safety and efficacy of infliximab given in combination with prednisone for the treatment of adults with PV.

A randomized, double-blind, placebo-controlled study for the treatment of patients with pemphigus vulgaris

Background

The Divisions of Dermatology at Duke University Medical Center, University of Pennsylvania School of Medicine, University of Iowa, and University of Southern California 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 Duke University Medical Center at the numbers listed below for more information regarding this trial and feel free to pass on this contact information to all interested individuals.

Duke University Medical Center:
Durham, NC

Principal Investigator:
Russell P. Hall III M.D.
919-684-3110
Russell.Hall@Duke.edu

Clinical Trial Coordinator:
Deborah Hannah
919-681-5797
Deborah.Hannah@Duke.edu

This study will last 26 weeks. At study entry, all patients will be taking a stable dose of prednisone (or an equivalent corticosteroid) of 20 to 120 mg/day for at least 2 weeks prior to study entry. Patients will be randomly assigned to one of two arms. The treatment arm will receive infusions of infliximab, and the control arm will receive placebo. Infusions will be given at study entry and Weeks 2, 6, and 14. Before the start of each infusion, a physical exam, vital signs measurement, medical and medication history, review of a disease activity log, a skin evaluation, and blood collection will occur. During each infusion and for 1 hour postinfusion, patients’ vital signs will be monitored for any adverse events. Patients will need a responsible adult to take them home after they are discharged from the treatment facility; this person should remain with the patient overnight in case any problems arise from the treatment. The patient will be contacted by phone that night and the next morning after infusion and will be asked about any adverse effects they may have experienced. Those patients that experience adverse effects may be asked to return to the treatment facility for examination. Prednisone doses may be tapered by 15% every 2 weeks during the study at the investigator’s discretion.

There will be a total of 9 study visits until Week 26: screening, study entry, Week 2, and every 4 weeks thereafter. Each study visit will include a physical exam, vital signs measurement, medical and medication history, a review of the disease activity log and adverse events experienced since the last visit, skin assessments, and blood collection; patients will also be asked to complete a tuberculosis (TB) questionnaire. Patients will be asked to complete quality of life questionnaires at study entry and Weeks 10, 18, and 26. Skin biopsies of unaffected skin will be done at study entry and Weeks 10, 18, and 26; if patients have PV-associated lesions, additional skin biopsies of affected skin will be done at study entry and Week 18.

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