Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
- Registration Number
- NCT00245960
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
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:
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Placebo 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. B etanercept 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. A etanercept Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).
- Primary Outcome Measures
Name Time Method Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis 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.
- Secondary Outcome Measures
Name Time Method Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) 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.
Trial Locations
- Locations (112)
SCIderm GmbH Hamburg
🇩🇪Hamburg, Germany
Klinikum Innenstadt der Universitaet Muenchen
🇩🇪Muenchen, Germany
Medical University of Szeged
🇭🇺Szeged, Hungary
Praxis Dr. M. Richter
🇩🇪Rostock, Germany
Semmelweis University - Faculty of Health Sciences
🇭🇺Budapest, Hungary
Instituto de Medicina Cutanea
🇦🇷Buenos Aires, Argentina
Hautarztpraxis Dr. Margrit Simon
🇩🇪Berlin, Germany
Klinische Forschung Berlin-Buch GmbH
🇩🇪Berlin, Germany
Mehiläinen Terveyspalvelut Oy Forum
🇫🇮Helsinki, Finland
Hospital A Posadas
🇦🇷Palomar, Buenos Aires, Argentina
Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052
🇩🇪Erlangen, Germany
Georg-August Universitaet Goettingen
🇩🇪Goettingen, Germany
Universitaetsklinik Wuerzburg
🇩🇪Wuerzburg, Germany
CHU - Hôpital Morvan
🇫🇷Brest cedex 2, France
Allgemeines Krankenhaus Eilbek
🇩🇪Hamburg-Eilbek, Germany
Friedrich-Schiller Universitat Jena
🇩🇪Jena, Germany
Bahnhofstr. 1
🇩🇪Mahlow, Germany
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Iho ja Allergiapulssi
🇫🇮Turku, Finland
CHU de l Archet
🇫🇷Nice, France
CHRU- Hôpital Trousseau
🇫🇷Tours, France
Hôpital Bichat - Claude Bernard
🇫🇷Paris, France
Klinik fuer Dermatologie, Venerologie und Allergologie
🇩🇪Berlin, Germany
Schlossparkklinik Berlin
🇩🇪Berlin, Germany
Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui
🇭🇺Miskolc, Hungary
Universita degli Studi di Parma
🇮🇹Parma, Italy
University of Athens Andreas Syngros Hospital Athens, Greece
🇬🇷Athens, Greece
Policlinico Umberto I - Universita La Sapienza
🇮🇹Roma, Italy
Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
University Medical Center St. Radboud
🇳🇱Nijmegen, GA, Netherlands
Asan Medical Centre
🇰🇷Seoul, Korea, Republic of
Unidad de Investigacion en
🇲🇽Guadalajara, Jalisco, Mexico
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
King Faisal Specialist Hospital & Research Centre
🇸🇦Riyadh, Saudi Arabia
National Taiwan University Hospital
🇨🇳Taipei TOC, Taiwan
CHUV Lausanne
🇨🇭Lausanne, Switzerland
Ospedale Galeazzi
🇮🇹Milano, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Ospedale San Giovanni di Dio
🇮🇹Cagliari, Italy
Clinica Dermatologica
🇮🇹Catania, Italy
Hospital de Donostia
🇪🇸San Sebastián, Guipúzcua, Spain
Hospital Severo Ochoa de Leganes
🇪🇸Leganes, Madrid, Spain
Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat
🇵🇱Warszawa, Poland
Hospital Santo Antonio
🇵🇹Porto, Portugal
Goulburn Street Medical Centre
🇦🇺Liverpool, New South Wales, Australia
CEMIC
🇦🇷Buenos Aires, Argentina
CHU Liege
🇧🇪Liege, Belgium
Krankenhaus Rudolfsstiftung
🇦🇹Wien, Austria
Hospital General de Agudos
🇦🇷Buenos Aires, Argentina
Bispebjerg University Hospital
🇩🇰Copenhagen, Denmark
Centrum Rehabilitace
🇨🇿Zlin, Czech Republic, Czechia
St Vincent's Hospital VIC
🇦🇺Fitzroy, Australia
Institute of Rheumatology Niska Banja
Niska Banja, Former Serbia and Montenegro
Universitaetsklinik Graz
🇦🇹Graz, SM, Austria
Centro Medico de la Sabana
🇨🇴Bogota, Colombia
Centro Integral de Reumatologia del Caribe S.A.S
🇨🇴Barranquilla, Atlantico, Colombia
Hôpital Saint André
🇫🇷Bordeaux, France
Odense University Hospital
🇩🇰Odense C, Denmark
Revmatologicky ustav
🇨🇿Praha 2, Czechia
Clinical Center Zemun
Zemun, Former Serbia and Montenegro
Hørsholm hospital
🇩🇰Hørsholm, Denmark
University of Copenhagen - Roskilde Hospital
🇩🇰Roskilde, Denmark
Hôpital Henri Mondor
🇫🇷Créteil cedex, France
CHU La Milétrie
🇫🇷Poitiers, France
Tampereen Reumatoismisto
🇫🇮Tampere, Finland
Institute of Rheumatology Belgrade
Belgrade, Former Serbia and Montenegro
Hopital Saint Louis
🇫🇷Paris, France
Clinic for Dermatology and Clinic for Medical Rehabilitation
Novi Sad, Former Serbia and Montenegro
C.H.R.U. de Caen
🇫🇷Caen, France
CHU Dupuytren
🇫🇷Limoges, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite, France
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
Schonhauser Allee 71
🇩🇪Berlin, Germany
Dermatologische Gemeinschaftspraxis Rosenbach
🇩🇪Osnabrueck, Germany
Idi-Irccs
🇮🇹Roma, Italy
Klinikum der J.W. Goethe-Universitat
🇩🇪Frankfurt, Germany
Hospitais Da Universidade De Coimbra
🇵🇹Coimbra, Portugal
Debreceni Egyetem Orvos és Egészségtudományi Centrum
🇭🇺Debrecen, Hungary
Pecsi Tudomanyegyetem, AOK
🇭🇺Pecs, Hungary
HETENYI Geza Hospital
🇭🇺Szolnok, Hungary
Universita degli Studi di Siena
🇮🇹Siena, Italy
CLIDITER S.A. de C.V.
🇲🇽Mexico City, Mexico
Ziekenhuis Walcheren
🇳🇱Vlissingen, Netherlands
Samodzielny Publiczny Szpital Kliniczny nr 4
🇵🇱Lublin, Poland
Diaconessenhuis Voorburg
🇳🇱Voorburg, Netherlands
Akademiska Sjukhuset i Uppsala
🇸🇪Uppsala, Sweden
Akad. Medyczna im L. Rydygiera
🇵🇱Bydgoszcz, Poland
Hospital Nuestra Senora Del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Puerto Real
🇪🇸Puerto Real, Cadiz, Spain
Hospital Insular de Canarias
🇪🇸Las Palmas de Gran Canaria, Isalas Canarias, Spain
Hospital de la Santa Cruz y San Pablo
🇪🇸Barcelona, Spain
Länssjukhuset Ryhov
🇸🇪Jönköping, Sweden
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
Umeå University Hospital
🇸🇪Umeå, Sweden
Chang Gung Memorial Hospital-Kaohsiung
🇨🇳Kaohsiung Hsiang, Taiwan, R.o.c., Taiwan
Leeds General Infirmary, Leeds
🇬🇧Leeds, Yorkshire, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, North Yorkshire, United Kingdom
Hacettepe University Medicine Faculty
🇹🇷Ankara, Turkey
Hope Hospital
🇬🇧Salford, Lancashire, United Kingdom
The Royal Free Hospital, Pond Street, Hampstead
🇬🇧London, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Guy's and St. Thomas' Trust St.Thomas' Hospital
🇬🇧London, United Kingdom
George Elliott Hospital
🇬🇧Nuneaton, United Kingdom
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Gentofte University Hospital
🇩🇰Hellerup, Denmark
Revmatologicka Ambulance
🇨🇿Uherske Hradiste, Czechia
Centre Hospitalier du Mans
🇫🇷Le Mans, Cedex, France
CHU - Hopital Charles Nicolle
🇫🇷Rouen, France
Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm
🇩🇪Bonn, Germany