Canada Only - Etanercept Derm

Condition(s) targeted: Psoriasis

Intervention: etanercept (Biological); etanercept (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Overall contact:
Amgen Call Center, Phone: 866-572-6436

This is a phase 3b, multicentre, randomized, open-label study wherein eligible subjects will be enrolled in the study and will recieved etanercept 50 mg twice weekly for 12 weeks. After 12 weeks of etanercept treatment, subjects will be randomized in a 1: 1 ratio to 1 of 2 treatment groups.

Official title: A Randomized, Blinded Assessor Study to Evaluate the Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent Versus Etanercept 50 mg Twice Weekly in Subjects With Moderate to Severe Plaque Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Psoriasis Area and Severity Index (PASI) scores between treatment groups

Secondary outcome:

Measure the change in health resource utilization between the two treatment groups using the Economic Implications of Psoriasis patient questionnaire

Measure the change in treatment satisfaction between the two treatment groups using the Treatment Satisfaction Questionnaire for Medications (TSQM)

The nature, frequency, severity and relationship of treatment to all adverse events reported throughout the study will be measured.

Measure changes in quality of life between the two treatment groups using the Dermatology Quality of Life Index

Efficacy of the 2 treatment groups as measured by a change in PASI scores

Efficacy of the 2 treatment groups as measured by a change in static physician's global assessment (sPGA) of psoriasis

Efficacy of the 2 treatment groups as measured by a change in body surface area (BSA) involvement

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no

morphology changes or significant flares of disease activity in the opinion of the investigator).

- Has a BSA involvement ≥ 10% and PASI ≥ 10 at screening and at baseline.

- Is a candidate for systemic therapy or phototherapy in the opinion of the

investigator.

- Other inclusion criteria may apply.

Exclusion Criteria:

- Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening

visit.

- Has evidence of skin conditions at the time of the screening visit (eg, eczema) that

would interfere with evaluations of the effect of etanercept on psoriasis.

- Diagnosed with medication-induced or medication-exacerbated psoriasis.

- Significant concurrent medical conditions.

- Has any active localized infection; requiring local intervention or chronic or

localized infections.

- Other exclusion criteria may apply.

Amgen Call Center, Phone: 866-572-6436

Research Site, Quebec, Canada; Recruiting

Research Site, Calgary, Alberta, Canada; Recruiting

Research Site, Surrey, British Columbia, Canada; Recruiting

Research Site, Vancouver, British Columbia, Canada; Recruiting

Research Site, Winnipeg, Manitoba, Canada; Recruiting

Research Site, Moncton, New Brunswick, Canada; Recruiting

Research Site, St. John's, Newfoundland and Labrador, Canada; Recruiting

Research Site, Halifax, Nova Scotia, Canada; Recruiting

Research Site, Courtice, Ontario, Canada; Recruiting

Research Site, Markham, Ontario, Canada; Recruiting

Research Site, North Bay, Ontario, Canada; Recruiting

Research Site, Peterborough, Ontario, Canada; Recruiting

Research Site, Richmond Hill, Ontario, Canada; Recruiting

Research Site, Toronto, Ontario, Canada; Recruiting

Research Site, Waterloo, Ontario, Canada; Recruiting

Research Site, Windsor, Ontario, Canada; Recruiting

Research Site, Montreal, Quebec, Canada; Recruiting

Research Site, Saint-Hyacinthe, Quebec, Canada; Recruiting

AmgenTrials clinical trials website

Starting date: April 2011
Last updated: September 22, 2011