Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis
This study has been completed.
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
First received: May 30, 2006
Last updated: October 30, 2013
Last verified: October 2013
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis|
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Participants With a Status of Mild or Better on Physician Global Assessment at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]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:
- Percent Change From Baseline to Month 12 in Patient Global Assessment [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2006|
|Study Completion Date:||February 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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.
Etanercept subcutaneous injection
Other Name: ENBREL
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