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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00332332
First received: May 30, 2006
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Psoriasis
Biological: etanercept
Phase 4

Study Type: Interventional
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.


Enrollment: 246
Study Start Date: March 2006
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332332

Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
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. Journal of Cutaneous Medicine and Surgery;2012 Dec 1;16(6):407-416

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00332332     History of Changes
Other Study ID Numbers: 20050180
Study First Received: May 30, 2006
Results First Received: November 5, 2010
Last Updated: July 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by Amgen:
Phase IV
Psoriasis
Inflammation

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014