Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

November 29, 2021 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS

The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

752

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

  • Argentina
      • Buenos Aires, Argentina, C1199ABD
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1001AFA
        • Hospital General de Agudos
      • Buenos Aires, Argentina, C1001AFA
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1014ADB
        • CEMIC
      • Buenos Aires, Argentina, C1155ADO
        • Hospital General de Agudos
      • Buenos Aires, Argentina, C1221ACJ
        • Instituto de Medicina Cutanea
    • Buenos Aires
      • Palomar, Buenos Aires, Argentina, 1684
        • Hospital A Posadas
  • Australia
      • Fitzroy, Australia, VIC 3065
        • St Vincent's Hospital VIC
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Goulburn Street Medical Centre
  • Austria
      • Wien, Austria, 1030
        • Krankenhaus Rudolfsstiftung
    • SM
      • Graz, SM, Austria, 8036
        • Universitaetsklinik Graz
  • Belgium
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Liege, Belgium, 4000
        • Chu Liege
  • Colombia
      • Bogota, Colombia
        • Centro Medico de la Sabana
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Centro Integral de Reumatología del Caribe S.A.S
  • Czechia
      • Praha 2, Czechia, 128 50
        • Revmatologicky ustav
      • Uherske Hradiste, Czechia, 686 01
        • Revmatologicka ambulance
    • Czech Republic
      • Zlin, Czech Republic, Czechia, 760 01
        • Centrum Rehabilitace
  • Denmark
      • Copenhagen, Denmark, DK-2400
        • Bispebjerg University Hospital
      • Hellerup, Denmark, 2900
        • Gentofte University Hospital
      • Hørsholm, Denmark, 2970
        • Hørsholm hospital
      • Odense C, Denmark, 5000
        • Odense University Hospital
      • Roskilde, Denmark, 4000
        • University of Copenhagen - Roskilde Hospital
  • Finland
      • Helsinki, Finland, FIN-00100
        • Mehiläinen Terveyspalvelut Oy Forum
      • Tampere, Finland, 33100
        • Tampereen Reumatoismisto
      • Turku, Finland, 20100
        • Iho ja Allergiapulssi
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro, 11000
        • Institute of Rheumatology Belgrade
      • Niska Banja, Former Serbia and Montenegro, 18205
        • Institute of Rheumatology Niska Banja
      • Novi Sad, Former Serbia and Montenegro, 21000
        • Clinic for Dermatology and Clinic for Medical Rehabilitation
      • Zemun, Former Serbia and Montenegro, 11080
        • Clinical Center Zemun
  • France
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Brest cedex 2, France, 29609
        • Chu - Hôpital Morvan
      • Caen, France, 14000
        • C.H.R.U. de Caen
      • Créteil cedex, France, 94000
        • Hopital Henri Mondor
      • Limoges, France, 87042
        • Chu Dupuytren
      • Nice, France, 06200
        • CHU de l Archet
      • Paris, France, 75018
        • Hôpital Bichat - Claude Bernard
      • Paris, France, 75010
        • Hopital Saint Louis
      • Pierre Bénite, France, 69310
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86000
        • Chu La Miletrie
      • Rouen, France, 76000
        • Chu - Hôpital Charles Nicolle
      • Tours, France, 37044
        • CHRU- Hôpital Trousseau
    • Cedex
      • Le Mans, Cedex, France, 72037
        • Centre Hospitalier du Mans
  • Germany
      • Bad Bentheim, Germany, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Germany, 13125
        • Klinische Forschung Berlin-Buch GmbH
      • Berlin, Germany, 10117
        • Klinik fuer Dermatologie, Venerologie und Allergologie
      • Berlin, Germany, 10437
        • Schonhauser Allee 71
      • Berlin, Germany, 10827
        • Hautarztpraxis Dr. Margrit Simon
      • Berlin, Germany, 14059
        • Schlossparkklinik Berlin
      • Bonn, Germany, 53105
        • Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm
      • Erlangen, Germany, 91052
        • Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052
      • Frankfurt, Germany, 60596
        • Klinikum der J.W. Goethe-Universität
      • Goettingen, Germany, D-37075
        • Georg-August Universitaet Goettingen
      • Hamburg, Germany, 20354
        • SCIderm GmbH Hamburg
      • Hamburg-Eilbek, Germany, 22081
        • Allgemeines Krankenhaus Eilbek
      • Jena, Germany, 07740
        • Friedrich-Schiller Universitat Jena
      • Jena, Germany, 07743
        • Friedrich-Schiller Universitat Jena
      • Mahlow, Germany, 15831
        • Bahnhofstr. 1
      • Muenchen, Germany, 80336
        • Klinikum Innenstadt der Universitaet Muenchen
      • Muenchen, Germany, 80337
        • Klinikum Innenstadt der Universitaet Muenchen
      • Osnabrueck, Germany, 49078
        • Dermatologische Gemeinschaftspraxis Rosenbach
      • Rostock, Germany, 18059
        • Praxis Dr. M. Richter
      • Wuerzburg, Germany, D-97070
        • Universitaetsklinik Wuerzburg
      • Wuerzburg, Germany, D-97080
        • Universitaetsklinik Wuerzburg
  • Greece
      • Athens, Greece, 16121
        • University of Athens Andreas Syngros Hospital Athens, Greece
  • Hungary
      • Budapest, Hungary, 1135
        • Semmelweis University - Faculty of Health Sciences
      • Debrecen, Hungary, H-4004
        • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
      • Miskolc, Hungary, 3529
        • Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui
      • Pecs, Hungary, 7624
        • Pécsi Tudományegyetem, ÁOK
      • Szeged, Hungary, 6720
        • Medical University of Szeged
      • Szolnok, Hungary, 5400
        • Hetenyi Geza Hospital
  • Italy
      • Brescia, Italy, 25100
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Cagliari, Italy, 09124
        • Ospedale San Giovanni di Dio
      • Catania, Italy, 95124
        • Clinica Dermatologica
      • Milano, Italy, 20161
        • Ospedale Galeazzi
      • Parma, Italy, 43100
        • Università degli Studi di Parma
      • Roma, Italy, 00161
        • Policlinico Umberto I - Università La Sapienza
      • Roma, Italy
        • Idi-Irccs
      • Siena, Italy, 53100
        • Università degli Studi di Siena
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Centre
  • Mexico
      • Mexico City, Mexico, 06700
        • Cliditer S.A. de C.V.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44620
        • Unidad de Investigacion en
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Academisch Ziekenhuis Maastricht
      • Vlissingen, Netherlands, 4382 EE
        • Ziekenhuis Walcheren
      • Voorburg, Netherlands, 2275 CX
        • Diaconessenhuis Voorburg
    • GA
      • Nijmegen, GA, Netherlands, 6525
        • University Medical Center St. Radboud
    • THE Netherlands
      • Maastricht, THE Netherlands, Netherlands, 6229 HX
        • Academisch Ziekenhuis Maastricht
  • Poland
      • Bydgoszcz, Poland
        • Akad. Medyczna im L. Rydygiera
      • Lublin, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny nr 4
      • Warszawa, Poland, 00-909
        • Wojskowy Instytut Medyczny
      • Warszawa, Poland, 00710
        • Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Hospitais da universidade de Coimbra
      • Porto, Portugal, 4050
        • Hospital Santo Antonio
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital & Research Centre
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Cruz y San Pablo
      • Barcelona, Spain, 08003
        • Hospital Nuestra Senora Del Mar
      • Madrid, Spain, 28037
        • Hospital Ramon y Cajal
    • Cadiz
      • Puerto Real, Cadiz, Spain, 11510
        • Hospital Universitario Puerto Real
    • Guipúzcua
      • San Sebastián, Guipúzcua, Spain, 20014
        • Hospital de Donostia
    • Isalas Canarias
      • Las Palmas de Gran Canaria, Isalas Canarias, Spain, 35016
        • Hospital Insular de Canarias
    • Madrid
      • Leganes, Madrid, Spain, 28911
        • Hospital Severo Ochoa de Leganes
  • Sweden
      • Jönköping, Sweden, 551 85
        • Länssjukhuset Ryhov
      • Umeå, Sweden, 90185
        • Umea University Hospital
      • Uppsala, Sweden, 751 85
        • Akademiska Sjukhuset i Uppsala
  • Switzerland
      • Lausanne, Switzerland, 1011
        • CHUV Lausanne
      • Zurich, Switzerland, 8091
        • Universitatsspital Zurich
  • Taiwan
      • Taipei TOC, Taiwan, 100
        • National Taiwan University Hospital
    • Taiwan, R.o.c.
      • Kaohsiung Hsiang, Taiwan, R.o.c., Taiwan, 833
        • Chang Gung Memorial Hospital-KaohSiung
  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Medicine Faculty
  • United Kingdom
      • Aberdeen, United Kingdom, AB15 4TN
        • Aberdeen Royal Infirmary
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Cardiff, United Kingdom, CF4 4XW
        • University Hospital of Wales
      • London, United Kingdom, NW3 2QG
        • The Royal Free Hospital, Pond Street, Hampstead
      • London, United Kingdom, SE1 7EH
        • Guy's and St. Thomas' Trust St.Thomas' Hospital
      • Nuneaton, United Kingdom, CV10 7DJ
        • George Elliott Hospital
    • Hampstead
      • London, Hampstead, United Kingdom, NW3 2QG
        • The Royal Free Hospital, Pond Street, Hampstead
    • Lancashire
      • Salford, Lancashire, United Kingdom, M6 8HD
        • Hope Hospital
    • North Yorkshire
      • Harrogate, North Yorkshire, United Kingdom, HG2 7SX
        • Harrogate District Hospital
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS1 3EX
        • Leeds General Infirmary, Leeds

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:

Inclusion Criteria:

  • 18 years of age or older at time of consent
  • Active Psoriatic Arthritis
  • Clinically stable, plaque psoriasis involving more than 10% of the body surface area

Exclusion Criteria:

Exclusion Criteria:

  • Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
  • Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
  • Prior exposure to any TNF-inhibitor, including etanercept

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).
Drug: etanercept
Active Comparator: B
Period 1 (Double Blind): 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW) for weeks 13-24.
Drug: Placebo
Drug: etanercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis
Time Frame: 12 weeks
The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)
Time Frame: 12 and 24 weeks
The PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
12 and 24 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

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

Helpful Links

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 (Actual)

December 27, 2005

Primary Completion (Actual)

March 29, 2008

Study Completion (Actual)

March 29, 2008

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A5-401
  • 2005-001533-15 (EudraCT Number)
  • B1801271 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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