Use of Infliximab for the Treatment of Pemphigus Vulgaris

Completed · Phase 2 · Has a placebo group

Conditions studied: Pemphigus

In brief

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.

Key facts

Study ID

NCT00283712

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Starts

2006-03-01

Expected to finish

2011-03-01

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Norris Cancer Center, University of Southern California — Los Angeles, California, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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