Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings

Condition(s) targeted: Psoriasis

Intervention: etanercept (Enbrel®) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany.

Official title: A Prospective Observational Cohort Study With Etanercept (Enbrel®) To Evaluate The Long-Term Management Of Patients With Plaque-Type Psoriasis In Usual Care Settings

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Determination of the average duration of the drug free interval between etanercept treatment cycles

Secondary outcome:

Comparison of effectiveness between subsequent cycle and the first cycle

Determination of adverse events (AE) and serious adverse events (SAE) rates on etanercept therapy

Health outcomes assessment

Detailed description: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

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

Criteria:

Inclusion Criteria:

- Subjects with moderate to severe plaque psoriasis on etanercept treatment according

to the Summary of Product Characteristics (SmPC), and applicable local guidelines

- Subjects for whom the decision has already been made to initiate treatment with

etanercept

Exclusion Criteria:

- Sepsis or risk of sepsis

- Current or recent infections, including chronic or localized, e. g. tuberculosis (TB)

infection

- Vaccination with live vaccine in last 4 weeks, or expected to require such

vaccination during the course of the study

- Pre-existing or recent onset CNS demyelinating disease.

- Class III or IV congestive heart failure as defined by the New York Heart Association

classification or uncompensated congestive heart failure.

- Previous or ongoing treatment with etanercept

- Participation in other clinical or observational studies.

- Patients with psoriatic arthritis requiring continuous etanercept treatment.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Muenster, NRW 48149, Germany; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: July 2008
Last updated: January 16, 2013