Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

February 20, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

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

  • Austria
      • Feldkirch, Austria
      • Wien, Austria, 1160
      • Wien, Austria, 1090
  • Belgium
      • Bruxelles, Belgium, B-1070
      • Bruxelles, Belgium, B-1200
      • Edegem, Belgium, B-2650
      • Gent, Belgium, B-9000
      • Leuven, Belgium, B-3000
      • Liege, Belgium, 4000
  • Czech Republic
      • Praha 8, Czech Republic, 180 01
  • Denmark
      • Aarhus C, Denmark, 8000
      • Odense C, Denmark, 5000
      • Roskilde, Denmark, 4000
  • Finland
      • Kuopio, Finland, 702 11
      • Lahti, Finland, 151 70
  • France
      • Besancon Cedex, France, 25030
      • Bordeaux, France, 33075
      • Boulogne Billancourt, France, 92104
      • Brest cedex 2, France, 29609
      • Créteil cedex, France, 94000
      • Dijon Cedex, France, 21079
      • Lille Cedex, France, 59037
      • Lyon Cedex 03, France, 69437
      • Lyon cedex 02, France, 60002
      • Marseille Cédex 09, France, 13009
      • Marseille cedex, France, 13915
      • Montpellier Cédex 5, France, 34000
      • Nancy, France, 54000
      • Nantes cedex 01, France, 44093
      • Nice, France, 06200
      • Nimes Cedex 9, France, 30029
      • Paris, France, 75018
      • Pessac Cedex, France, 33600
      • Pierre Benite cedex, France, 69495
      • Poitiers, France, 86000
      • Reims, France, 51092
      • Rouen, France, 76000
      • Saint-Etienne, France, 42055
      • Strasbourg cedex, France, 6700
      • Toulouse Cedex, France, 31059
      • Tours, France, 37044
  • Germany
      • Bochum, Germany, 44791
      • Düsseldorf, Germany, 40225
      • Erlangen, Germany, 91052
      • Essen, Germany, 45147
      • Frankfurt, Germany, 60590
      • Hamburg, Germany, 20158
      • Kiel, Germany, 24105
      • Leipzig, Germany, 04103
      • Magdeburg, Germany, 39120
      • Mainz, Germany, D-55101
      • Münster, Germany, 48149
      • Nordheide, Germany, 21244
      • Osnabrück, Germany, 48149
      • Tübingen, Germany, 72076
      • Wurzburg, Germany, 97080
  • Greece
      • Athens, Greece
      • Athens, Greece, 124 62
      • Thessaloniki, Greece, 54636
  • Hungary
      • Budapest, Hungary, 1135
  • Italy
      • Ancona, Italy, 60020
      • Cagliari, Italy, 09124
      • Genova, Italy, 16132
      • Modena, Italy, 41100
      • Padova, Italy, 35100
      • Pavia, Italy, 27100
      • Roma, Italy, 00168
      • Roma, Italy, 00133
      • Roma, Italy, 00185
      • Terni, Italy, 05100
      • Torino, Italy
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
      • Amsterdam, Netherlands, 1105 - AZ
      • Capelle Aan Den Ijssel, Netherlands, 2906 ZC
      • Heerlen, Netherlands, 6419 PC
      • Nijmegen, Netherlands, 6525 GL
      • Rotterdam, Netherlands, 1081 HV
      • Utrecht, Netherlands, 3584 CX
      • Voorburg, Netherlands, 2275 CX
  • Norway
      • Bergen, Norway, 5021
      • Oslo, Norway, 0407
      • Stavanger, Norway, 4068
  • Poland
      • Warszawa, Poland, 02-008
  • Portugal
      • LIsboa, Portugal, 1169-100
      • Lisboa, Portugal, 1069-166
  • Spain
      • Barcelona, Spain, 08915
      • Bilbao, Spain, 48009
      • Llobregat, Spain, 8907
      • Madrid, Spain, 28006
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Malaga, Spain, 29010
      • Valencia, Spain, 46014
  • Sweden
      • Danderyds, Sweden, 182 88
      • Göteborg, Sweden, 413 45
      • Linkoping, Sweden, 581 85
      • Lund, Sweden, 221 85
      • Stockholm, Sweden, 171 76
      • Umea, Sweden, 901 85
  • Switzerland
      • Basel, Switzerland, 4056
      • Bern, Switzerland, 3010
      • Geneva, Switzerland, 1205
  • Turkey
      • Bornova-Izmir, Turkey, 35100
      • Capa-Istanbul, Turkey, 34390
      • Kocamustafapasa-Istanbul, Turkey, 34122
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 1LD
      • Airdrie, United Kingdom, ML6 0JS
      • Birmingham, United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
      • Coventry, United Kingdom, CV2 2DX
      • Dublin, United Kingdom
      • Dundee, United Kingdom, DD1 9SY
      • Glasgow, United Kingdom, G11 6NT
      • Lancaster, United Kingdom, LA1 4RP
      • Leeds, United Kingdom, LS1 3EX
      • Leicester, United Kingdom, LE1 5WW
      • Liverpool, United Kingdom
      • London, United Kingdom, E11 1NR
      • London, United Kingdom, SE1 7EH
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, W 12
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
      • Newport, United Kingdom
      • Norwich, United Kingdom, NR4 7UY
      • Salford, United Kingdom, M6 8HD
      • Sheffield, United Kingdom, 1OUK - S10
      • Suffolk, United Kingdom, IP4 5PD

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable, active plaque psoriasis
  • Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate

Exclusion Criteria:

  • Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
  • Systemic psoriasis therapy within 28 days prior

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
Measure Description
Time Frame
Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
Time Frame: 54 weeks
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).
54 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline
Time Frame: 54 weeks
Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.
54 weeks
Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"
Time Frame: 54 weeks
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.
54 weeks
Number of Patients With Survey Response of "Somewhat Satisfied" or Better
Time Frame: 54 weeks
Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.
54 weeks

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

Investigators

  • Principal Investigator: Trial Manager, For Austria, WPVIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
  • Principal Investigator: Trial Manager, For Turkey, Erisc@wyeth.com
  • Principal Investigator: Trial manager, For Hungary, WPBUMED@wyeth.com
  • Principal Investigator: Trial Manager, For Italy,Greece, decresg@wyeth.com
  • Principal Investigator: Trial Manager, For Denmark, Finland, Sweden, Norway, MedInfoNord@wyeth.com
  • Principal Investigator: Trial Manager, For UK, ukmedonfo@wyeth.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2004

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A6-101764

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.

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