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

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Biological: etanercept

• Registration Number: NCT00332332
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-06-01
• Primary Completion: 2009-07
• Study Completion: 2010-02
• Results First Submitted: 2010-11-05
• Results First Submitted QC: 2011-06-03
• Results First Posted: 2011-06-14
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-18
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
etanercept	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.

Primary Outcome Measures

Name	Time	Method
Participants With a Status of Mild or Better on Physician Global Assessment at Month 12	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 Outcome Measures

Name	Time	Method
Percent Change From Baseline to Month 12 in Patient Global Assessment	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	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	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.