Use of Infliximab for the Treatment of Pemphigus Vulgaris

Exclusion Criteria

• •Positive tuberculosis (TB) test within 1 month prior to first administration of study drug
• •History of latent or active TB prior to screening
• •Signs or symptoms suggestive of TB disease by medical history or physical examination within 3 months prior to first administration of study drug
• •Posterior/anterior/lateral chest radiograph within 3 months prior to screening showing evidence of cancer, infection, or abnormalities (apical scarring) suggestive of previous TB
• •Serious infection, hospitalization for an infection, or treatment with intravenous (IV) antibiotics for an infection within 2 months prior to screening. Patients who have had less serious infections are eligible for this study at the discretion of the investigator.
• •History or presence of opportunistic infections within 6 months prior to screening
• •History of receiving human/murine recombinant products
• •Known allergy to murine products or other chimeric proteins
• •Human immunodeficiency virus (HIV) infected
• •Chronic hepatitis B or hepatitis C virus infection
• •History of hepatitis C virus infection
• •Cancer within the 5 years prior to study entry. Patients with completely resected non-melanoma skin cancers are not excluded.
• •History or presence of congestive heart failure
• •History or presence of seizure or demyelinating disorder
• •History of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis
• •Received a Bacillus Calmette-Guerin (BCG) vaccine within 12 months of screening
• •History of lymphoproliferative disease, including lymphoma or signs and symptoms of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location or enlarged spleen
• •Current signs or symptoms of severe progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurologic, or cerebral disease
• •Have had chronic or recurrent infectious disease including, but not limited to, chronic kidney infection, chronic chest infection, sinusitis, recurrent urinary tract infection, infected skin wound, or ulcer
• •Previous treatment with infliximab, other monoclonal antibodies, or antibody fragments
• •Previous treatment with etanercept or other anti-tumor necrosis factor (TNF) agents in the 3 months prior to screening
• •Treatment with methotrexate, azathioprine, mycophenolate mofetil, plasmapheresis, IV immunoglobulin, pulse systemic corticosteroids, or other systemic immunosuppressive agents within the 4 weeks prior to study entry
• •History of alcohol or drug abuse within the 3 years prior to study entry
• •History of noncompliance to medical regimens
• •History of a systemic inflammatory disease other than pemphigus vulgaris
• •History of a medical condition that would interfere with participation or increase the risk to the participant
• •Unable or unwilling to undergo blood draws because of poor tolerability or lack of easy access
• •Use of any investigational drug within 30 days prior to screening OR within 5 half-lives of the investigational agent, whichever is longer
• •Participation in another investigative clinical trial
• •Presence of transplanted solid organ. Participants who have received a corneal transplant more than 3 months prior to screening are not excluded.
• •Require certain medications
• •Other conditions or circumstances that could interfere with participant's adherence to the study requirements
• •Pregnancy, breastfeeding, or plans to become pregnant