NCT00161655
Completed
Phase 4
A Multicenter, Open-label, Randomized, Pilot-study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients With Plaque Psoriasis Despite Methotrexate Therapy
Wyeth is now a wholly owned subsidiary of Pfizer0 sites60 target enrollmentApril 2005
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 60
- Primary Endpoint
- Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Active plaque psoriasis involving \>10% body surface area and/or minimal screening PASI score
- •Methotrexate \>7.5 mg/week for the last 3 months
Exclusion Criteria
- •Predominantly guttate, erythrodermic or pustular psoriasis
- •Other skin conditions than psoriasis
Outcomes
Primary Outcomes
Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
Secondary Outcomes
- Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
- and 90. Time to clear or almost clear on PGA.
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