Clinical trial NCT00245960: Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Skin Disease
Joint Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Palomar
country: Argentina
facility: Hospital A Posadas
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: CEMIC
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Medicina Cutanea
city: Liverpool
country: Australia
facility: Goulburn Street Medical Centre
state: New South Wales
city: Fitzroy
country: Australia
facility: St Vincent's Hospital VIC
city: Graz
country: Austria
facility: Universitaetsklinik Graz
state: SM
city: Wien
country: Austria
facility: Krankenhaus Rudolfsstiftung
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: CHU Liege
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatologia del Caribe S.A.S
state: Atlantico
city: Bogota
country: Colombia
facility: Centro Medico de la Sabana
city: Zlin
country: Czechia
facility: Centrum Rehabilitace
state: Czech Republic
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: Revmatologicka Ambulance
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
city: Hørsholm
country: Denmark
facility: Hørsholm hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: University of Copenhagen - Roskilde Hospital
city: Helsinki
country: Finland
facility: Mehiläinen Terveyspalvelut Oy Forum
city: Tampere
country: Finland
facility: Tampereen Reumatoismisto
city: Turku
country: Finland
facility: Iho ja Allergiapulssi
city: Belgrade
country: Former Serbia and Montenegro
facility: Institute of Rheumatology Belgrade
city: Niska Banja
country: Former Serbia and Montenegro
facility: Institute of Rheumatology Niska Banja
city: Novi Sad
country: Former Serbia and Montenegro
facility: Clinic for Dermatology and Clinic for Medical Rehabilitation
city: Zemun
country: Former Serbia and Montenegro
facility: Clinical Center Zemun
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
state: Cedex
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Brest cedex 2
country: France
facility: CHU - Hôpital Morvan
city: Caen
country: France
facility: C.H.R.U. de Caen
city: Créteil cedex
country: France
facility: Hôpital Henri Mondor
city: Limoges
country: France
facility: CHU Dupuytren
city: Nice
country: France
facility: CHU de l Archet
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU La Milétrie
city: Rouen
country: France
facility: CHU - Hopital Charles Nicolle
city: Tours
country: France
facility: CHRU- Hôpital Trousseau
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Klinik fuer Dermatologie, Venerologie und Allergologie
city: Berlin
country: Germany
facility: Schonhauser Allee 71
city: Berlin
country: Germany
facility: Hautarztpraxis Dr. Margrit Simon
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Buch GmbH
city: Berlin
country: Germany
facility: Schlossparkklinik Berlin
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm
city: Erlangen
country: Germany
facility: Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe-Universitat
city: Goettingen
country: Germany
facility: Georg-August Universitaet Goettingen
city: Hamburg-Eilbek
country: Germany
facility: Allgemeines Krankenhaus Eilbek
city: Hamburg
country: Germany
facility: SCIderm GmbH Hamburg
city: Jena
country: Germany
facility: Friedrich-Schiller Universitat Jena
city: Jena
country: Germany
facility: Friedrich-Schiller Universitat Jena
city: Mahlow
country: Germany
facility: Bahnhofstr. 1
city: Muenchen
country: Germany
facility: Klinikum Innenstadt der Universitaet Muenchen
city: Muenchen
country: Germany
facility: Klinikum Innenstadt der Universitaet Muenchen
city: Osnabrueck
country: Germany
facility: Dermatologische Gemeinschaftspraxis Rosenbach
city: Rostock
country: Germany
facility: Praxis Dr. M. Richter
city: Wuerzburg
country: Germany
facility: Universitaetsklinik Wuerzburg
city: Wuerzburg
country: Germany
facility: Universitaetsklinik Wuerzburg
city: Athens
country: Greece
facility: University of Athens Andreas Syngros Hospital Athens, Greece
city: Budapest
country: Hungary
facility: Semmelweis University - Faculty of Health Sciences
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum
city: Miskolc
country: Hungary
facility: Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem, AOK
city: Szeged
country: Hungary
facility: Medical University of Szeged
city: Szolnok
country: Hungary
facility: HETENYI Geza Hospital
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Cagliari
country: Italy
facility: Ospedale San Giovanni di Dio
city: Catania
country: Italy
facility: Clinica Dermatologica
city: Milano
country: Italy
facility: Ospedale Galeazzi
city: Parma
country: Italy
facility: Universita degli Studi di Parma
city: Roma
country: Italy
facility: Policlinico Umberto I - Universita La Sapienza
city: Roma
country: Italy
facility: Idi-Irccs
city: Siena
country: Italy
facility: Universita degli Studi di Siena
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Centre
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion en
state: Jalisco
city: Mexico City
country: Mexico
facility: CLIDITER S.A. de C.V.
city: Nijmegen
country: Netherlands
facility: University Medical Center St. Radboud
state: GA
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
state: THE Netherlands
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Vlissingen
country: Netherlands
facility: Ziekenhuis Walcheren
city: Voorburg
country: Netherlands
facility: Diaconessenhuis Voorburg
city: Bydgoszcz
country: Poland
facility: Akad. Medyczna im L. Rydygiera
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warszawa
country: Poland
facility: Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat
city: Coimbra
country: Portugal
facility: Hospitais Da Universidade De Coimbra
city: Porto
country: Portugal
facility: Hospital Santo Antonio
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerto Real
state: Cadiz
city: San Sebastián
country: Spain
facility: Hospital de Donostia
state: Guipúzcua
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Canarias
state: Isalas Canarias
city: Leganes
country: Spain
facility: Hospital Severo Ochoa de Leganes
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Nuestra Senora Del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Cruz y San Pablo
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
city: Umeå
country: Sweden
facility: Umeå University Hospital
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset i Uppsala
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
city: Kaohsiung Hsiang
country: Taiwan
facility: Chang Gung Memorial Hospital-Kaohsiung
state: Taiwan, R.o.c.
city: Taipei TOC
country: Taiwan
facility: National Taiwan University Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medicine Faculty
city: London
country: United Kingdom
facility: The Royal Free Hospital, Pond Street, Hampstead
state: Hampstead
city: Salford
country: United Kingdom
facility: Hope Hospital
state: Lancashire
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: North Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary, Leeds
state: Yorkshire
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: The Royal Free Hospital, Pond Street, Hampstead
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Trust St.Thomas' Hospital
city: Nuneaton
country: United Kingdom
facility: George Elliott Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Griffiths 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.
citation: Kirkham 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.
citation: Griffiths 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.
citation: Gniadecki 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.
citation: Sterry 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.