Status:
COMPLETED
Use of Infliximab for the Treatment of Pemphigus Vulgaris
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Autoimmunity Centers of Excellence
Conditions:
Pemphigus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, inclu...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00283712
Start Date
March 1 2006
End Date
March 1 2011
Last Update
December 6 2017
Active Locations (4)
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1
Norris Cancer Center, University of Southern California
Los Angeles, California, United States, 90033
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104