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Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
etanercept
etanercept
Placebo
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, Skin Disease, Joint Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital A Posadas
  • Hospital General de Agudos
  • Hospital Italiano de Buenos Aires
  • CEMIC
  • Hospital General de Agudos
  • Hospital Italiano de Buenos Aires
  • Instituto de Medicina Cutanea
  • Goulburn Street Medical Centre
  • St Vincent's Hospital VIC
  • Universitaetsklinik Graz
  • Krankenhaus Rudolfsstiftung
  • Universitair Ziekenhuis Gent
  • CHU Liege
  • Centro Integral de Reumatologia del Caribe S.A.S
  • Centro Medico de la Sabana
  • Centrum Rehabilitace
  • Revmatologicky ustav
  • Revmatologicka Ambulance
  • Bispebjerg University Hospital
  • Gentofte University Hospital
  • Hørsholm hospital
  • Odense University Hospital
  • University of Copenhagen - Roskilde Hospital
  • Mehiläinen Terveyspalvelut Oy Forum
  • Tampereen Reumatoismisto
  • Iho ja Allergiapulssi
  • Institute of Rheumatology Belgrade
  • Institute of Rheumatology Niska Banja
  • Clinic for Dermatology and Clinic for Medical Rehabilitation
  • Clinical Center Zemun
  • Centre Hospitalier du Mans
  • Hôpital Saint André
  • CHU - Hôpital Morvan
  • C.H.R.U. de Caen
  • Hôpital Henri Mondor
  • CHU Dupuytren
  • CHU de l Archet
  • Hopital Saint Louis
  • Hôpital Bichat - Claude Bernard
  • Centre Hospitalier Lyon Sud
  • CHU La Milétrie
  • CHU - Hopital Charles Nicolle
  • CHRU- Hôpital Trousseau
  • Fachklinik Bad Bentheim
  • Klinik fuer Dermatologie, Venerologie und Allergologie
  • Schonhauser Allee 71
  • Hautarztpraxis Dr. Margrit Simon
  • Klinische Forschung Berlin-Buch GmbH
  • Schlossparkklinik Berlin
  • Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm
  • Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052
  • Klinikum der J.W. Goethe-Universitat
  • Georg-August Universitaet Goettingen
  • Allgemeines Krankenhaus Eilbek
  • SCIderm GmbH Hamburg
  • Friedrich-Schiller Universitat Jena
  • Friedrich-Schiller Universitat Jena
  • Bahnhofstr. 1
  • Klinikum Innenstadt der Universitaet Muenchen
  • Klinikum Innenstadt der Universitaet Muenchen
  • Dermatologische Gemeinschaftspraxis Rosenbach
  • Praxis Dr. M. Richter
  • Universitaetsklinik Wuerzburg
  • Universitaetsklinik Wuerzburg
  • University of Athens Andreas Syngros Hospital Athens, Greece
  • Semmelweis University - Faculty of Health Sciences
  • Debreceni Egyetem Orvos és Egészségtudományi Centrum
  • Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui
  • Pecsi Tudomanyegyetem, AOK
  • Medical University of Szeged
  • HETENYI Geza Hospital
  • Azienda Ospedaliera Spedali Civili di Brescia
  • Ospedale San Giovanni di Dio
  • Clinica Dermatologica
  • Ospedale Galeazzi
  • Universita degli Studi di Parma
  • Policlinico Umberto I - Universita La Sapienza
  • Idi-Irccs
  • Universita degli Studi di Siena
  • Seoul National University Hospital
  • Asan Medical Centre
  • Unidad de Investigacion en
  • CLIDITER S.A. de C.V.
  • University Medical Center St. Radboud
  • Academisch Ziekenhuis Maastricht
  • Academisch Ziekenhuis Maastricht
  • Ziekenhuis Walcheren
  • Diaconessenhuis Voorburg
  • Akad. Medyczna im L. Rydygiera
  • Samodzielny Publiczny Szpital Kliniczny nr 4
  • Wojskowy Instytut Medyczny
  • Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat
  • Hospitais Da Universidade De Coimbra
  • Hospital Santo Antonio
  • King Faisal Specialist Hospital & Research Centre
  • Hospital Universitario Puerto Real
  • Hospital de Donostia
  • Hospital Insular de Canarias
  • Hospital Severo Ochoa de Leganes
  • Hospital Nuestra Senora Del Mar
  • Hospital de la Santa Cruz y San Pablo
  • Hospital Ramon y Cajal
  • Länssjukhuset Ryhov
  • Umeå University Hospital
  • Akademiska Sjukhuset i Uppsala
  • CHUV Lausanne
  • Universitatsspital Zurich
  • Chang Gung Memorial Hospital-Kaohsiung
  • National Taiwan University Hospital
  • Hacettepe University Medicine Faculty
  • The Royal Free Hospital, Pond Street, Hampstead
  • Hope Hospital
  • Harrogate District Hospital
  • Leeds General Infirmary, Leeds
  • Aberdeen Royal Infirmary
  • University Hospital of Wales
  • University Hospital of Wales
  • The Royal Free Hospital, Pond Street, Hampstead
  • Guy's and St. Thomas' Trust St.Thomas' Hospital
  • George Elliott Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 26, 2005
Last Updated
November 29, 2021
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00245960
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 27, 2005 (Actual)
Primary Completion Date
March 29, 2008 (Actual)
Study Completion Date
March 29, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic Arthritis, Skin Disease, Joint Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
752 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).
Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
etanercept
Intervention Type
Drug
Intervention Name(s)
etanercept
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)
Description
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.
Time Frame
12 and 24 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
30323006
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.
Results Reference
derived
PubMed Identifier
25913550
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.
Results Reference
derived
PubMed Identifier
25535650
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.
Results Reference
derived
PubMed Identifier
24861696
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.
Results Reference
derived
PubMed Identifier
22035157
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.
Results Reference
derived
PubMed Identifier
20124563
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A5-401&StudyName=Study%20evaluating%20Etanercept%20on%20Skin%20and%20Joint%20Disease%20in%20Psoriatic%20Arthritis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

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