Clinical trial NCT00332332: Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis
Official title: Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Phase IV
Psoriasis
Inflammation
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2006-06-01
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Participants With a Status of Mild or Better on Physician Global Assessment at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Percent Change From Baseline to Month 12 in Patient Global Assessment
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.