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

NCT00708708

Last updated date
Study Location
Westfaelische Wilhelms-Universitaet Muenster, Zentr. f. Derm
Muenster, NRW, 48149, Germany
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings
Official Title 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
Brief 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.
Detailed Description Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with moderate to severe plaque psoriasis
Condition Psoriasis
Intervention 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.
Study Groups/Cohorts A
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 Status Completed
Actual Enrollment
 (submitted: July 31, 2014)
926
Original Estimated Enrollment
 (submitted: July 1, 2008)
750
Actual Study Completion Date December 2013
Actual Primary Completion Date December 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00708708
Other Study ID Numbers 0881X1-4499
B1801081 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2015