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

Overview

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.

Full Title of Study: “Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2009

Interventions

  • Biological: etanercept
    • etanercept subcutaneous injection

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amgen
  • Collaborator
    • Wyeth is now a wholly owned subsidiary of Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • MD, Study Director, Amgen

References

Vender R, Lynde C, Gilbert M, Ho V, Sapra S, Poulin-Costello M. One-year, multicenter, open-label, single-arm study evaluating the safety and effectiveness of etanercept for the treatment of moderate-to-severe plaque psoriasis in a Canadian population. J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38. doi: 10.2310/7750.2012.12036.

Vender R, Lynde C, Gilbert M, Ho V, Sapra S, Poulin-Costello M. Etanercept improves quality of life outcomes and treatment satisfaction in patients with moderate to severe plaque psoriasis in clinical practice. J Cutan Med Surg. 2012 Nov-Dec;16(6):407-16. doi: 10.1177/120347541201600609.

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