Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

Phase 4

Completed

• Conditions: Psoriasis; Arthritis, Psoriatic

• Registration Number: NCT00161655
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2006-08
• Study Completion: 2006-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-25
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Active plaque psoriasis involving >10% body surface area and/or minimal screening PASI score 8.
• Methotrexate >7.5 mg/week for the last 3 months

Exclusion Criteria

• Predominantly guttate, erythrodermic or pustular psoriasis
• Other skin conditions than psoriasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.

Secondary Outcome Measures

Name	Time	Method
Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
and 90. Time to clear or almost clear on PGA.