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

Last updated on November 8, 2019

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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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Descriptive Information
Brief TitleObservational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings
Official TitleA 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
Brief SummaryThis 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 DescriptionNon-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with moderate to severe plaque psoriasis
ConditionPsoriasis
InterventionDrug: 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.
Study Groups/CohortsA
Patients with moderate to severe plaque psoriasis
Intervention: Drug: etanercept (Enbrel®)
Publications *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.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: July 31, 2014)
926
Original Estimated Enrollment
 (submitted: July 1, 2008)
750
Actual Study Completion DateDecember 2013
Actual Primary Completion DateDecember 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00708708
Other Study ID Numbers0881X1-4499
B1801081 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2015

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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