Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245960
• Other study ID #: 0881A5-401
• Secondary ID: 2005-001533-15B1
• Status: Completed
• Phase: Phase 4
• Start date: December 27, 2005
• Est. completion date: March 29, 2008

Study information

• Verified date: November 2021
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: March 29, 2008
• Est. primary completion date: March 29, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Joint Diseases
• Psoriatic Arthritis

Intervention

Drug:
• etanercept

• etanercept

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Colombia,  Czechia,  Denmark,  Finland,  Former Serbia and Montenegro,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Saudi Arabia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	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

External Links

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