Phase 4
Completed N=246
Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis
Source: ClinicalTrials.gov NCT00332332 ↗Enrolled (actual)
246
Serious AEs
5.2%
Results posted
Jun 2011
Primary outcomePrimary: Participants With a Status of Mild or Better on Physician Global Assessment at Month 12 — 166 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Status of Mild or Better on Physician Global Assessment at Month 12 |
166 | — |
| SECONDARY Percent Change From Baseline to Month 12 in Patient Global Assessment |
-57.9 | — |
| SECONDARY Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis |
-69.9 | — |
| SECONDARY Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score |
-68.2 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00332332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.