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

Last updated on April 11, 2018

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Study Location
Westfaelische Wilhelms-Universitaet Muenster, Zentr. f. Derm
Muenster, NRW, 48149 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00708708
Pfizer
Completed
Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings

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Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings
A Prospective Non-interventional Study (Nis) Of The Routine Use Of Etanercept In The Long-term Treatment Of Patients With Plaque-type Psoriasis In Everyday Practice: An Efficacy, Safety, And Health Economic Evaluation
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.
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with moderate to severe plaque psoriasis
Psoriasis
Drug: 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.
A
Patients with moderate to severe plaque psoriasis
Intervention: Drug: etanercept (Enbrel®)
Luger T, Schopf RE, Schwanke A, Langhammer S, Meng T, Löschmann 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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
926
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00708708
0881X1-4499
B1801081 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2015

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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