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Use of Infliximab for the Treatment of Pemphigus Vulgaris

NCT00283712 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-12-06

Study results available
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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.

Conditions

  • Pemphigus

Interventions

DRUG

Infliximab

Chimeric IgG monoclonal antibody that binds to TNF-alpha, generally used to treat Crohn's disease, given in a dosage of 5 mg/kg

OTHER

Placebo Comparator

Placebo administered in place of infliximab for control group

Sponsors & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Russell P. Hall, MD · Division of Dermatology, Duke University Medical Center

  • E. William St. Clair, MD · Division of Rheumatology and Immunology, Duke University Medical Center

  • Garnett Kelsoe, DSci · Department of Immunology, Duke University

  • Victoria Werth, MD · Department of Dermatology, University of Pennsylvania School of Medicine

  • Janet Fairley, MD · Department of Dermatology, University of Iowa

  • David Woodley, MD · Department of Dermatology, Norris Cancer Center, University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00283712 on ClinicalTrials.gov