Use of Infliximab for the Treatment of Pemphigus Vulgaris

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Autoimmunity Centers of Excellence
• Treatments: Infliximab; Prednisone

Criteria

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