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

Information source: Amgen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: etanercept (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Participants With a Status of Mild or Better on Physician Global Assessment at Month 12

Secondary outcome:

Percent Change From Baseline to Month 12 in Patient Global Assessment

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Related publications:

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.

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.

Starting date: March 2006
Last updated: July 18, 2014

Page last updated: August 20, 2015

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