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Study Complete
Sponsor ID
20050180

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

Sponsor ID
20050180
Clinicaltrials.gov ID
NCT00332332
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
246
Additional Study Details

Protocol Summary

Primary Outcome Measures

Status of Mild or Better on Physician Global Assessment at Month 12

Timeframe: Month 12

Secondary Outcome Measures

Percent Change from Baseline to Month 12 in Patient Global Assessment

Timeframe: Baseline and Month 12

Percent Change from Baseline to Month 12 in Body Surface Area

Timeframe: Baseline and Month 12

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

Timeframe: Baseline and Month 12

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Mar 2006 - Jul 2009
    Inclusion and Exclusion 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.