Pemphigus Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone
Pemphigus vulgaris (PV) is a rare skin disorder that causes blistering of the skin and mucous membranes. Infliximab is a man-made antibody used to treat certain types of immune system disorders, including rheumatoid arthritis and Crohn's disease. 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.
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: experimental or
placebo comparator. The experimental 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 percent 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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