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:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT00606450
Eligibility Criteria:
Inclusion Criteria:
* Must understand and voluntarily sign and informed consent form
* Must be in good health as judged by the investigator
* Must be able to adhere to the study visit schedule and other protocol requirements
* Must have greater than or equal to a 6 month history of moderate-to-severe plaque-type psoriasis
* Must have a Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and Body Surface Area (BSA) greater than or equal to 10%
* Must meet specific laboratory criteria
* Must be a candidate for photo/systemic therapy
* Women of childbearing potential must have a negative pregnancy test
Exclusion Criteria:
* Must not have clinically significant underlying disease processes
* Must not be pregnant or lactating females
* Must not have any condition, including lab abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study
* Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
* Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
* Must not have a know history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
* Must not be an immigrant form a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
* Must not have current erythrodermic, guttate, or pustular psoriasis
* Must not have a clinical history of failure to adequately respond to treatment in the investigator's opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab
* Must not use topical therapy within 14 days of randomization
* Must not use systemic therapy for psoriasis within 28 days of randomization
* Must not use phototherapy within 28 days of randomization
* Must not use adalimumab or infliximab within 3 months of randomization
* Must not use etanercept or efalizumab within 56 days of randomization
* Must not use alefacept within 6 months of randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00606450
Study Brief:
Protocol Section:
NCT00606450