Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

September 25, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- Copenhagen
  - Fredriksberg Alle, Copenhagen, Denmark
- Hellerup
  - Gentofte Amtsygehus, Hellerup, Denmark
Finland
- - Helsinki, Finland
  - Tampere, Finland
Norway
- Olso
  - Rikshospitalet, Olso, Norway
- Tromso
  - Hudlegekontoret Akutten, Tromso, Norway
Sweden
- Farsta
  - Lakarhuset Fasta Centrum, Farsta, Sweden
- Vallingby
  - Lakarhuset, Vallingby, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 28, 2009

Last Update Submitted That Met QC Criteria

September 25, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

0881A-101696

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.