Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161655
• Other study ID #: 0881A-101696
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: September 25, 2009
• Start date: April 2005
• Est. completion date: December 2006

Study information

• Verified date: September 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyNorway: Norwegian Medicines AgencySweden: Swedish National Council on Medical EthicsFinland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Psoriasis

Intervention

Drug:
• Etanercept

• Methotrexate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
Secondary	Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
Secondary	and 90. Time to clear or almost clear on PGA.