NCT00195507CompletedPhase 4
A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis
Wyeth is now a wholly owned subsidiary of Pfizer127 sites in 7 countries720 target enrollmentStarted: December 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 720
- Locations
- 127
- Primary Endpoint
- Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
Study Overview
Brief Summary
This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stable, active plaque psoriasis
- •Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate
Exclusion Criteria
- •Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
- •Systemic psoriasis therapy within 28 days prior
Outcomes
Primary Outcomes
Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
Time Frame: 54 weeks
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).
Secondary Outcomes
- Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline(54 weeks)
- Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"(54 weeks)
- Number of Patients With Survey Response of "Somewhat Satisfied" or Better(54 weeks)
Investigators
Study Sites (127)
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