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

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ClinicalTrials.gov Identifier: NCT00332332
Recruitment Status : Completed
First Posted : June 1, 2006
Results First Posted : June 14, 2011
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: etanercept Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis
Study Start Date : March 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: etanercept
etanercept subcutaneous injection
Other Name: ENBREL


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332332


Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
More Information
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Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00332332     History of Changes
Other Study ID Numbers: 20050180
First Posted: June 1, 2006    Key Record Dates
Results First Posted: June 14, 2011
Last Update Posted: July 25, 2014
Last Verified: July 2014

Keywords provided by Amgen:
Phase IV
Psoriasis
Inflammation

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors