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Psoriatic ArthritisPhase 4NCT00245960

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

A Phase 4 study testing etanercept in people with Psoriatic Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 120 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
etanercept
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
752 participants
Where
120 sitesin 26 countries
Study dates
27 Dec 2005to 29 Mar 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

120 sites in 26 countries.

120 sites in 26 countries

Germany21 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Klinik fuer Dermatologie, Venerologie und Allergologie

    Berlin, 10117

  • Schonhauser Allee 71

    Berlin, 10437

  • Hautarztpraxis Dr. Margrit Simon

    Berlin, 10827

  • Klinische Forschung Berlin-Buch GmbH

    Berlin, 13125

  • Schlossparkklinik Berlin

    Berlin, 14059

  • Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm

    Bonn, 53105

  • Allgemeines Krankenhaus Eilbek

    Eilbek, 22081

  • Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052

    Erlangen, 91052

  • Klinikum der J.W. Goethe-Universitat

    Frankfurt, 60596

  • Georg-August Universitaet Goettingen

    Göttingen, D-37075

  • SCIderm GmbH Hamburg

    Hamburg, 20354

  • Friedrich-Schiller Universitat Jena

    Jena, 07740

  • Friedrich-Schiller Universitat Jena

    Jena, 07743

  • Bahnhofstr. 1

    Mahlow, 15831

  • Klinikum Innenstadt der Universitaet Muenchen

    München, 80336

  • Klinikum Innenstadt der Universitaet Muenchen

    München, 80337

  • Dermatologische Gemeinschaftspraxis Rosenbach

    Osnabrück, 49078

  • Praxis Dr. M. Richter

    Rostock, 18059

  • Universitaetsklinik Wuerzburg

    Würzburg, D-97070

  • Universitaetsklinik Wuerzburg

    Würzburg, D-97080

Other trials in Germany

France13 sites

  • Hôpital Saint André

    Bordeaux, 33075

  • CHU - Hôpital Morvan

    Brest, 29609

  • C.H.R.U. de Caen

    Caen, 14000

  • Hôpital Henri Mondor

    Créteil, 94000

  • Centre Hospitalier du Mans

    Le Mans, Cedex, 72037

  • CHU Dupuytren

    Limoges, 87042

  • CHU de l Archet

    Nice, 06200

  • Hopital Saint Louis

    Paris, 75010

  • Hôpital Bichat - Claude Bernard

    Paris, 75018

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • CHU La Milétrie

    Poitiers, 86000

  • CHU - Hopital Charles Nicolle

    Rouen, 76000

  • CHRU- Hôpital Trousseau

    Tours, 37044

Other trials in France

United Kingdom10 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB15 4TN

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • University Hospital of Wales

    Cardiff, CF4 4XW

  • Harrogate District Hospital

    Harrogate, North Yorkshire, HG2 7SX

  • Leeds General Infirmary, Leeds

    Leeds, Yorkshire, LS1 3EX

  • The Royal Free Hospital, Pond Street, Hampstead

    London, Hampstead, NW3 2QG

  • The Royal Free Hospital, Pond Street, Hampstead

    London, NW3 2QG

  • Guy's and St. Thomas' Trust St.Thomas' Hospital

    London, SE1 7EH

  • George Elliott Hospital

    Nuneaton, CV10 7DJ

  • Hope Hospital

    Salford, Lancashire, M6 8HD

Other trials in United Kingdom

Italy8 sites

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25100

  • Ospedale San Giovanni di Dio

    Cagliari, 09124

  • Clinica Dermatologica

    Catania, 95124

  • Ospedale Galeazzi

    Milan, 20161

  • Universita degli Studi di Parma

    Parma, 43100

  • Policlinico Umberto I - Universita La Sapienza

    Roma, 00161

  • Idi-Irccs

    Roma

  • Universita degli Studi di Siena

    Siena, 53100

Other trials in Italy

Argentina7 sites

  • Hospital General de Agudos

    Buenos Aires, C1001AFA

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1001AFA

  • CEMIC

    Buenos Aires, C1014ADB

  • Hospital General de Agudos

    Buenos Aires, C1155ADO

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABD

  • Instituto de Medicina Cutanea

    Buenos Aires, C1221ACJ

  • Hospital A Posadas

    Palomar, Buenos Aires, 1684

Other trials in Argentina

Spain7 sites

  • Hospital Nuestra Senora Del Mar

    Barcelona, 08003

  • Hospital de la Santa Cruz y San Pablo

    Barcelona, 08025

  • Hospital Insular de Canarias

    Las Palmas de Gran Canaria, Isalas Canarias, 35016

  • Hospital Severo Ochoa de Leganes

    Leganés, Madrid, 28911

  • Hospital Ramon y Cajal

    Madrid, 28037

  • Hospital Universitario Puerto Real

    Puerto Real, Cadiz, 11510

  • Hospital de Donostia

    San Sebastián, Guipúzcua, 20014

Other trials in Spain

Hungary6 sites

  • Semmelweis University - Faculty of Health Sciences

    Budapest, 1135

  • Debreceni Egyetem Orvos és Egészségtudományi Centrum

    Debrecen, H-4004

  • Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui

    Miskolc, 3529

  • Pecsi Tudomanyegyetem, AOK

    Pécs, 7624

  • Medical University of Szeged

    Szeged, 6720

  • HETENYI Geza Hospital

    Szolnok, 5400

Other trials in Hungary

Denmark5 sites

  • Bispebjerg University Hospital

    Copenhagen, DK-2400

  • Gentofte University Hospital

    Hellerup, 2900

  • Hørsholm hospital

    Hørsholm, 2970

  • Odense University Hospital

    Odense C, 5000

  • University of Copenhagen - Roskilde Hospital

    Roskilde, 4000

Other trials in Denmark

Netherlands5 sites

  • Ziekenhuis Walcheren

    Flushing, 4382 EE

  • Academisch Ziekenhuis Maastricht

    Maastricht, THE Netherlands, 6229 HX

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX

  • University Medical Center St. Radboud

    Nijmegen, GA, 6525

  • Diaconessenhuis Voorburg

    Voorburg, 2275 CX

Other trials in Netherlands

Poland4 sites

  • Akad. Medyczna im L. Rydygiera

    Bydgoszcz

  • Samodzielny Publiczny Szpital Kliniczny nr 4

    Lublin, 20-954

  • Wojskowy Instytut Medyczny

    Warsaw, 00-909

  • Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat

    Warsaw, 00710

Other trials in Poland

Serbia and Montenegro4 sites

  • Institute of Rheumatology Belgrade

    Belgrade, 11000

  • Institute of Rheumatology Niska Banja

    Niska Banja, 18205

  • Clinic for Dermatology and Clinic for Medical Rehabilitation

    Novi Sad, 21000

  • Clinical Center Zemun

    Zemun, 11080

Other trials in Serbia and Montenegro

Czechia3 sites

  • Revmatologicky ustav

    Prague, 128 50

  • Revmatologicka Ambulance

    Uherské Hradiště, 686 01

  • Centrum Rehabilitace

    Zlín, Czech Republic, 760 01

Other trials in Czechia

Finland3 sites

  • Mehiläinen Terveyspalvelut Oy Forum

    Helsinki, FIN-00100

  • Tampereen Reumatoismisto

    Tampere, 33100

  • Iho ja Allergiapulssi

    Turku, 20100

Other trials in Finland

Sweden3 sites

  • Länssjukhuset Ryhov

    Jönköping, 551 85

  • Umeå University Hospital

    Umeå, 90185

  • Akademiska Sjukhuset i Uppsala

    Uppsala, 751 85

Other trials in Sweden

Australia2 sites

  • St Vincent's Hospital VIC

    Fitzroy, VIC 3065

  • Goulburn Street Medical Centre

    Liverpool, New South Wales, 2170

Other trials in Australia

Austria2 sites

  • Universitaetsklinik Graz

    Graz, SM, 8036

  • Krankenhaus Rudolfsstiftung

    Vienna, 1030

Other trials in Austria

Belgium2 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • CHU Liege

    Liège, 4000

Other trials in Belgium

Colombia2 sites

  • Centro Integral de Reumatologia del Caribe S.A.S

    Barranquilla, Atlántico

  • Centro Medico de la Sabana

    Bogotá

Other trials in Colombia

Mexico2 sites

  • Unidad de Investigacion en

    Guadalajara, Jalisco, 44620

  • CLIDITER S.A. de C.V.

    Mexico City, 06700

Other trials in Mexico

Portugal2 sites

  • Hospitais Da Universidade De Coimbra

    Coimbra, 3000-075

  • Hospital Santo Antonio

    Porto, 4050

Other trials in Portugal

South Korea2 sites

  • Seoul National University Hospital

    Seoul, 110-744

  • Asan Medical Centre

    Seoul, 138-736

Other trials in South Korea

Switzerland2 sites

  • CHUV Lausanne

    Lausanne, 1011

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Taiwan2 sites

  • Chang Gung Memorial Hospital-Kaohsiung

    Kaohsiung Hsiang, Taiwan, R.o.c., 833

  • National Taiwan University Hospital

    Taipei TOC, 100

Other trials in Taiwan

Greece1 site

  • University of Athens Andreas Syngros Hospital Athens, Greece

    Athens, 16121

Other trials in Greece

Saudi Arabia1 site

  • King Faisal Specialist Hospital & Research Centre

    Riyadh, 11211

Other trials in Saudi Arabia

Turkey (Türkiye)1 site

  • Hacettepe University Medicine Faculty

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
etanercept, Placebo
Keywords
Psoriatic Arthritis, Skin Disease, Joint Disease
Medical subject headings
Arthritis, Psoriatic, Skin Diseases, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00245960
Study groupRoleWhat they receive
AActive comparatorPeriod 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).
Receives: Drug: etanercept
BActive 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.
Receives: Drug: etanercept; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (1)

  1. 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.

    Measured: 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2005 (estimated)
  2. Study start27 Dec 2005
  3. Primary completion29 Mar 2008
  4. Study completion29 Mar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00245960
Sponsor's protocol ID
0881A5-401
Other IDs
2005-001533-15, B1801271, 2005
Status last verified
Nov 2021
First submitted
26 Oct 2005
Last updated
31 Jan 2022
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 30323006

  • 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.

    PubMed 25913550

  • 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.

    PubMed 25535650

  • 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.

    PubMed 24861696

  • 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.

    PubMed 22035157

  • 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.

    PubMed 20124563

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing etanercept in people with Psoriatic Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 120 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in Germany, France, United Kingdom, Italy, Argentina and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00245960, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.

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