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Clinical Trials/NCT00161655
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.

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
December 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

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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