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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

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

Summary

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.

Clinical Details

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

Eligibility

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.

Locations and Contacts

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

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

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

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

Page last updated: February 07, 2013

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