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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)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

This is an observational safety study tracking psoriasis subjects on Enbrel for 5 years.

Clinical Details

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)

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 drug study

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: May 2006
Ending date: June 2013
Last updated: May 22, 2008

Page last updated: June 20, 2008

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