Description:

ODM derived from http://clinicaltrials.gov/show/NCT00606450

Link:

http://clinicaltrials.gov/show/NCT00606450

Keywords:
Versions (2) ▾
  1. 12/10/13
  2. 4/15/14
Uploaded on:

April 15, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY 4.0
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Eligibility NCT00606450 Psoriasis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Alter mindestens 18 Jahre
Must understand and voluntarily sign an 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 a >= 6 month history of moderate-to-severe plaque-type psoriasis
Must have a PASI score >=10 and BSA >=10%
Must meet specific laboratory criteria
Must be a candidate for photo/systemic therapy
Women of childbearing potential must have a negative pregnancy test
Ausschlusskriterien
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 known history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
Must not be an immigrant from 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