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

NCT ID: NCT00708708

Last Updated: 2015-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

926 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Patients with moderate to severe plaque psoriasis

etanercept (Enbrel®)

Intervention Type DRUG

The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Interventions

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etanercept (Enbrel®)

The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Westfaelische Wilhelms-Universitaet Muenster, Zentr. f. Derm

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Luger T, Schopf RE, Schwanke A, Langhammer S, Meng T, Loschmann PA. An observational study to evaluate the long-term outcomes of treatment with etanercept in patients with plaque-type psoriasis. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1730-1741. doi: 10.1111/jdv.13673. Epub 2016 Jun 14.

Reference Type DERIVED
PMID: 27297981 (View on PubMed)

Related Links

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Other Identifiers

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B1801081

Identifier Type: OTHER

Identifier Source: secondary_id

0881X1-4499

Identifier Type: -

Identifier Source: org_study_id

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