Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT00283712
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00283712
Study Brief:
Protocol Section:
NCT00283712