A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone

Inclusion Criteria:

- Positive direct immunofluorescence of patient's skin showing IgG or complement C3
protein on cell surface with histopathology of lesional skin biopsies consistent with
diagnosis of pemphigus vulgaris

- Failure to completely respond to standard steroid therapy (equivalent to prednisone 1
to 2 mg/kg/day followed by tapering)

- Systemic corticosteroid therapy of at least 20 mg prednisone daily and no more than
120 mg/day

- Inability to reduce systemic corticosteroid dosage below 20 mg/day for at least 8
weeks

- Stable dosage of prednisone for at least 2 weeks prior to study entry

- Oral/mucosal disease or skin disease. Detailed information about this criterion can
be found in the protocol

- Willing to comply with the study protocol

- Willing to use acceptable means of contraception for the duration of the study and
for 6 months after the end of the study

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