Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
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
3 other identifiers
interventional
752
24 countries
115
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2005
Typical duration for phase_4
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2005
CompletedFirst Posted
Study publicly available on registry
October 28, 2005
CompletedStudy Start
First participant enrolled
December 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2008
CompletedResults Posted
Study results publicly available
May 27, 2009
CompletedJanuary 31, 2022
November 1, 2021
2.3 years
October 26, 2005
March 31, 2009
November 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis
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 Outcomes (1)
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)
12 and 24 weeks
Study Arms (2)
A
ACTIVE COMPARATORPeriod 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).
B
ACTIVE COMPARATORPeriod 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (120)
Hospital A Posadas
Palomar, Buenos Aires, 1684, Argentina
Hospital General de Agudos
Buenos Aires, C1001AFA, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1001AFA, Argentina
CEMIC
Buenos Aires, C1014ADB, Argentina
Hospital General de Agudos
Buenos Aires, C1155ADO, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABD, Argentina
Instituto de Medicina Cutanea
Buenos Aires, C1221ACJ, Argentina
Goulburn Street Medical Centre
Liverpool, New South Wales, 2170, Australia
St Vincent's Hospital VIC
Fitzroy, VIC 3065, Australia
Universitaetsklinik Graz
Graz, SM, 8036, Austria
Krankenhaus Rudolfsstiftung
Vienna, 1030, Austria
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
CHU Liege
Liège, 4000, Belgium
Centro Integral de Reumatologia del Caribe S.A.S
Barranquilla, Atlántico, Colombia
Centro Medico de la Sabana
Bogotá, Colombia
Centrum Rehabilitace
Zlín, Czech Republic, 760 01, Czechia
Revmatologicky ustav
Prague, 128 50, Czechia
Revmatologicka Ambulance
Uherské Hradiště, 686 01, Czechia
Bispebjerg University Hospital
Copenhagen, DK-2400, Denmark
Gentofte University Hospital
Hellerup, 2900, Denmark
Hørsholm hospital
Hørsholm, 2970, Denmark
Odense University Hospital
Odense C, 5000, Denmark
University of Copenhagen - Roskilde Hospital
Roskilde, 4000, Denmark
Mehiläinen Terveyspalvelut Oy Forum
Helsinki, FIN-00100, Finland
Tampereen Reumatoismisto
Tampere, 33100, Finland
Iho ja Allergiapulssi
Turku, 20100, Finland
Centre Hospitalier du Mans
Le Mans, Cedex, 72037, France
Hôpital Saint André
Bordeaux, 33075, France
CHU - Hôpital Morvan
Brest, 29609, France
C.H.R.U. de Caen
Caen, 14000, France
Hôpital Henri Mondor
Créteil, 94000, France
CHU Dupuytren
Limoges, 87042, France
CHU de l Archet
Nice, 06200, France
Hopital Saint Louis
Paris, 75010, France
Hôpital Bichat - Claude Bernard
Paris, 75018, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
CHU La Milétrie
Poitiers, 86000, France
CHU - Hopital Charles Nicolle
Rouen, 76000, France
CHRU- Hôpital Trousseau
Tours, 37044, France
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Klinik fuer Dermatologie, Venerologie und Allergologie
Berlin, 10117, Germany
Schonhauser Allee 71
Berlin, 10437, Germany
Hautarztpraxis Dr. Margrit Simon
Berlin, 10827, Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, 13125, Germany
Schlossparkklinik Berlin
Berlin, 14059, Germany
Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm
Bonn, 53105, Germany
Allgemeines Krankenhaus Eilbek
Eilbek, 22081, Germany
Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052
Erlangen, 91052, Germany
Klinikum der J.W. Goethe-Universitat
Frankfurt, 60596, Germany
Georg-August Universitaet Goettingen
Göttingen, D-37075, Germany
SCIderm GmbH Hamburg
Hamburg, 20354, Germany
Friedrich-Schiller Universitat Jena
Jena, 07740, Germany
Friedrich-Schiller Universitat Jena
Jena, 07743, Germany
Bahnhofstr. 1
Mahlow, 15831, Germany
Klinikum Innenstadt der Universitaet Muenchen
München, 80336, Germany
Klinikum Innenstadt der Universitaet Muenchen
München, 80337, Germany
Dermatologische Gemeinschaftspraxis Rosenbach
Osnabrück, 49078, Germany
Praxis Dr. M. Richter
Rostock, 18059, Germany
Universitaetsklinik Wuerzburg
Würzburg, D-97070, Germany
Universitaetsklinik Wuerzburg
Würzburg, D-97080, Germany
University of Athens Andreas Syngros Hospital Athens, Greece
Athens, 16121, Greece
Semmelweis University - Faculty of Health Sciences
Budapest, 1135, Hungary
Debreceni Egyetem Orvos és Egészségtudományi Centrum
Debrecen, H-4004, Hungary
Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui
Miskolc, 3529, Hungary
Pecsi Tudomanyegyetem, AOK
Pécs, 7624, Hungary
Medical University of Szeged
Szeged, 6720, Hungary
HETENYI Geza Hospital
Szolnok, 5400, Hungary
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25100, Italy
Ospedale San Giovanni di Dio
Cagliari, 09124, Italy
Clinica Dermatologica
Catania, 95124, Italy
Ospedale Galeazzi
Milan, 20161, Italy
Universita degli Studi di Parma
Parma, 43100, Italy
Policlinico Umberto I - Universita La Sapienza
Roma, 00161, Italy
Idi-Irccs
Roma, Italy
Universita degli Studi di Siena
Siena, 53100, Italy
Unidad de Investigacion en
Guadalajara, Jalisco, 44620, Mexico
CLIDITER S.A. de C.V.
Mexico City, 06700, Mexico
University Medical Center St. Radboud
Nijmegen, GA, 6525, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, THE Netherlands, 6229 HX, Netherlands
Ziekenhuis Walcheren
Flushing, 4382 EE, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX, Netherlands
Diaconessenhuis Voorburg
Voorburg, 2275 CX, Netherlands
Akad. Medyczna im L. Rydygiera
Bydgoszcz, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4
Lublin, 20-954, Poland
Wojskowy Instytut Medyczny
Warsaw, 00-909, Poland
Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat
Warsaw, 00710, Poland
Hospitais Da Universidade De Coimbra
Coimbra, 3000-075, Portugal
Hospital Santo Antonio
Porto, 4050, Portugal
King Faisal Specialist Hospital & Research Centre
Riyadh, 11211, Saudi Arabia
Institute of Rheumatology Belgrade
Belgrade, 11000, Serbia and Montenegro
Institute of Rheumatology Niska Banja
Niska Banja, 18205, Serbia and Montenegro
Clinic for Dermatology and Clinic for Medical Rehabilitation
Novi Sad, 21000, Serbia and Montenegro
Clinical Center Zemun
Zemun, 11080, Serbia and Montenegro
Seoul National University Hospital
Seoul, 110-744, South Korea
Asan Medical Centre
Seoul, 138-736, South Korea
Hospital Universitario Puerto Real
Puerto Real, Cadiz, 11510, Spain
Hospital de Donostia
San Sebastián, Guipúzcua, 20014, Spain
Hospital Insular de Canarias
Las Palmas de Gran Canaria, Isalas Canarias, 35016, Spain
Hospital Severo Ochoa de Leganes
Leganés, Madrid, 28911, Spain
Hospital Nuestra Senora Del Mar
Barcelona, 08003, Spain
Hospital de la Santa Cruz y San Pablo
Barcelona, 08025, Spain
Hospital Ramon y Cajal
Madrid, 28037, Spain
Länssjukhuset Ryhov
Jönköping, 551 85, Sweden
Umeå University Hospital
Umeå, 90185, Sweden
Akademiska Sjukhuset i Uppsala
Uppsala, 751 85, Sweden
CHUV Lausanne
Lausanne, 1011, Switzerland
Universitatsspital Zurich
Zurich, 8091, Switzerland
Chang Gung Memorial Hospital-Kaohsiung
Kaohsiung Hsiang, Taiwan, R.o.c., 833, Taiwan
National Taiwan University Hospital
Taipei TOC, 100, Taiwan
Hacettepe University Medicine Faculty
Ankara, 06100, Turkey (Türkiye)
The Royal Free Hospital, Pond Street, Hampstead
London, Hampstead, NW3 2QG, United Kingdom
Hope Hospital
Salford, Lancashire, M6 8HD, United Kingdom
Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Leeds General Infirmary, Leeds
Leeds, Yorkshire, LS1 3EX, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, AB15 4TN, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
University Hospital of Wales
Cardiff, CF4 4XW, United Kingdom
The Royal Free Hospital, Pond Street, Hampstead
London, NW3 2QG, United Kingdom
Guy's and St. Thomas' Trust St.Thomas' Hospital
London, SE1 7EH, United Kingdom
George Elliott Hospital
Nuneaton, CV10 7DJ, United Kingdom
Related Publications (6)
Coates LC, Gottlieb AB, Merola JF, Boone C, Szumski A, Chhabra A. Comparison of Different Remission and Low Disease Definitions in Psoriatic Arthritis and Evaluation of Their Prognostic Value. J Rheumatol. 2019 Feb;46(2):160-165. doi: 10.3899/jrheum.180249. Epub 2018 Oct 15.
PMID: 30323006DERIVEDGriffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.
PMID: 25913550DERIVEDKirkham B, de Vlam K, Li W, Boggs R, Mallbris L, Nab HW, Tarallo M. Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.
PMID: 25535650DERIVEDGriffiths CE, Sterry W, Brock F, Dilleen M, Stefanidis D, Germain JM, Mallbris L. Pattern of response in patients with moderate-to-severe psoriasis treated with etanercept. Br J Dermatol. 2015 Jan;172(1):230-8. doi: 10.1111/bjd.13139. Epub 2014 Nov 13.
PMID: 24861696DERIVEDGniadecki R, Robertson D, Molta CT, Freundlich B, Pedersen R, Li W, Boggs R, Zbrozek AS. Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens. J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1436-43. doi: 10.1111/j.1468-3083.2011.04308.x. Epub 2011 Oct 31.
PMID: 22035157DERIVEDSterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.
PMID: 20124563DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2005
First Posted
October 28, 2005
Study Start
December 27, 2005
Primary Completion
March 29, 2008
Study Completion
March 29, 2008
Last Updated
January 31, 2022
Results First Posted
May 27, 2009
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
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.