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Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00332332
First received: May 30, 2006
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the use of Enbrel® (etanercept) in the treatment of psoriasis in patients for a period of up to 1 year.


Condition Intervention Phase
Psoriasis
 Biological: ENBREL (entanercept)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Status of Mild or Better on Physician Global Assessment at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) at month 12. This scale ranges from 0 to 5, with 0 = best outcome.


Secondary Outcome Measures:
  • Percent Change From Baseline to Month 12 in Patient Global Assessment [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    Percent change from baseline to month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe).

  • Percent Change From Baseline to Month 12 in Body Surface Area [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    Percent change from baseline to month 12 in body surface area (BSA) affected by psoriasis.

  • Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    Percent change from baseline to month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, with 0 = no effect and 30 = large effect.


Enrollment: 246
Study Start Date: March 2006
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ENBREL (Etanercept)
OPEN LABEL SINGLE ARM TREATMENT WITH ENBREL (Etanercept)
 Biological: ENBREL (entanercept)
INTERVENTION WITH ENBREL (Etanercept) IN SUBJECTS WITH PSORIASIS Open label, Enbrel (Etanercept) 50 mg twice weekly SC for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older at baseline
  • Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)
  • Able to start Enbrel (Etanercept) therapy per the approved product monograph
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332332

Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00332332     History of Changes
Other Study ID Numbers: 20050180
Study First Received: May 30, 2006
Results First Received: November 5, 2010
Last Updated: May 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by Amgen:
Phase IV
Psoriasis
Inflammation

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

ClinicalTrials.gov processed this record on May 23, 2013