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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00708708
First received: June 30, 2008
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Psoriasis
Drug: etanercept (Enbrel®)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Determination of the average duration of the drug free interval between etanercept treatment cycles [ Time Frame: 36 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of effectiveness between subsequent cycle and the first cycle [ Time Frame: 36 month ] [ Designated as safety issue: No ]
  • Determination of adverse events (AE) and serious adverse events (SAE) rates on etanercept therapy [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
  • Health outcomes assessment [ Time Frame: 36 month ] [ Designated as safety issue: No ]

Enrollment: 926
Study Start Date: June 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Patients with moderate to severe plaque 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with moderate to severe plaque psoriasis

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708708

Locations
Germany
Pfizer Investigational Site
Muenster, NRW, Germany, 48149
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00708708     History of Changes
Other Study ID Numbers: 0881X1-4499, B1801081
Study First Received: June 30, 2008
Last Updated: July 31, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pfizer:
Plaque-type psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Immunoglobulin G
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014