Observational Safety Study of Enbrel for Treatment of Psoriasis
Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: etanercept (Drug); Enbrel (Drug)
Status: Active, not recruiting
Sponsored by: Amgen
Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
This is an observational safety study tracking psoriasis subjects on Enbrel for 5 years.
Official title: Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis
Study design: Cohort, Prospective
Primary outcome: Assessed long-term safety of participating subjects determined incidence rates of Serious Adverse Events (SAEs) and Serious Infectious Events (SIEs)
Evaluated incidence rates of Events of Medical Interests (EMIs) for participating subjects
Whether rates of SAEs, SIEs, and EMIs differ according to (a) prior exposure to systemic therapies or phototherapy, (b) exposure to Enbrel therapy, and (c) presence of certain co-morbid disorders
Patient- and physician- reported outcomes and healthcare resource use over time
Minimum age: 18 Years.
Maximum age: N/A.
Inclusion Criteria: - Patients with plaque psoriasis Exclusion Criteria: - Prior exposure
to any TNF-inhibitor, - Subjects for whom Enbrel is contraindicated, - Subjects currently
enrolled in or has not yet completed at least 30 days since ending other investigational
Locations and Contacts
AmgenTrials clinical trials website
Starting date: May 2006
Ending date: June 2013
Last updated: May 22, 2008