Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) 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: November 21, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Psoriasis
Biological: 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:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Participants With a Status of Mild or Better on Physician Global Assessment at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis 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). A negative change from Baseline indicates improvement in disease activity.

  • Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis [ 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. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.

  • 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, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.


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
Experimental: Etanercept
Open label etanercept 50 mg twice weekly subcutaneously (SC) for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months.
Biological: Entanercept
Etanercept subcutaneous injection
Other Name: ENBREL

  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

Exclusion Criteria

  • Active infections at the initiation of Enbrel therapy.
  • Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B (UVB) therapy within 2 weeks of study drug initiation.
  • Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug initiation and during the study period.
  • Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug initiation and during the study period.
  • Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept) within 3 months before the initiation of study medication or during the study period.
  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:
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: November 21, 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 April 21, 2014