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Completed

NCT Number: NCT00332332

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

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.

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Key information

Conditions

Psoriasis Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etanercept

Biological

etanercept subcutaneous injection

Other names: ENBREL

Primary outcomes

  1. Participants With a Status of Mild or Better on Physician Global Assessment at Month 12

    Time frame: Month 12

    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 outcomes

  1. Percent Change From Baseline to Month 12 in Patient Global Assessment

    Time frame: Baseline and Month 12

    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.

  2. Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis

    Time frame: Baseline and Month 12

    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.

  3. Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score

    Time frame: Baseline and Month 12

    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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Jun 1, 2006
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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