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Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriatic Arthritis

Intervention: etanercept (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Trial Manager, Principal Investigator, Affiliation: For Argentina, scheima@wyeth.com or rendop@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Denmark, Finland, Sweden, MedInfoNord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, medinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Greece, decresg@wyeth.com
Trial Manger, Principal Investigator, Affiliation: For Hungary, WPBUMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Australia, Korea, Taiwan, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Mexico, gomezlj@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial manager, Principal Investigator, Affiliation: For Switzerland, med@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Turkey, Erisc@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For UK, ukmedinfo@wyeth.comÂ
Trial Manager, Principal Investigator, Affiliation: For Austria, WPVIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Portugal,Saudi Arabia, clintrialparticipation@wyeth.com
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For France, infomedfrance@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Italy, descresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Spain, infomed@wyeth.com

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

Summary

To assess the efficacy of two different treatment regimens of etanercept in psoriasis subjects with psoriatic arthritis with respect to both the skin and joint manifestations.

Clinical Details

Official title: A Randomized, Double-Blind, Two-Period Study to Evaluate the Safety and Efficacy of Etanercept on Skin and Joint Disease in Psoriasis Subjects With Psoriatic Arthritis.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: To compare the efficacy of the two different treatment regimens of etanercept in treating the skin manifestations of psoriasis subjects with psoriatic arthritis.

Secondary outcome: Compare the efficacy of two different treatment regimens of etanercept in treating joint disease.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

- 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

Locations and Contacts

Trial Manager, Email: clintrialparticipation@wyeth.com

Buenos Aires, Argentina; Recruiting

Buenos Aires 982, Argentina; Recruiting

Buenos Aires 1234, Argentina; Recruiting

Fitzroy Victoria 3065, Australia; Recruiting

Liverpool 2170, Australia; Recruiting

Wien 1030, Austria; Recruiting

Graz 8036, Austria; Recruiting

Liege 4000, Belgium; Recruiting

Ghent 9000, Belgium; Recruiting

Havlickova 686 01, Czech Republic; Recruiting

Praha 120 00, Czech Republic; Recruiting

Zlin 760 01, Czech Republic; Recruiting

Kopenhavn NV 2400, Denmark; Recruiting

Roskilde 4000, Denmark; Recruiting

Hellerup 2900, Denmark; Recruiting

Odense C 5000, Denmark; Recruiting

Horsholm 2970, Denmark; Recruiting

Helsinki 00280, Finland; Recruiting

Oulu 90029, Finland; Not yet recruiting

Abo 20100, Finland; Recruiting

Tampere 33100, Finland; Recruiting

Creteil 94010, France; Active, not recruiting

Limoges 87000, France; Recruiting

Paris 75010, France; Recruiting

Poitiers 86000, France; Recruiting

Rouen Cedex 76031, France; Recruiting

Tours 37044, France; Recruiting

Brest 29200, France; Recruiting

Pierre Bénite 69310, France; Recruiting

Nice Cedex 06202, France; Recruiting

Bordeaux 33076, France; Active, not recruiting

Le Mans Cedex 72037, France; Recruiting

Caen Cedex 14033, France; Active, not recruiting

Paris Cedex 75877, France; Recruiting

Berlin 10117, Germany; Recruiting

München 80337, Germany; Active, not recruiting

Hamburg 20354, Germany; Recruiting

Bonn 53105, Germany; Recruiting

Mahlow 15831, Germany; Recruiting

Jena 07740, Germany; Active, not recruiting

Berlin 10437, Germany; Active, not recruiting

Erlangen 91052, Germany; Recruiting

Wurzburg 97080, Germany; Recruiting

Frankfurt-am-Main 60590, Germany; Recruiting

Bad Bentheim 48455, Germany; Recruiting

Osnabruck 49078, Germany; Recruiting

Berlin 10827, Germany; Recruiting

Berlin 14059, Germany; Recruiting

Hamburg D-22081, Germany; Recruiting

Berlin D-13125, Germany; Recruiting

Athens 161 21, Greece; Not yet recruiting

Thessaloniki 546 44, Greece; Not yet recruiting

Debrecen 4004, Hungary; Recruiting

Budapest 1085, Hungary; Recruiting

Koranyi, Hungary; Recruiting

Kodaly, Hungary; Recruiting

Szolnok 5004, Hungary; Recruiting

Miskolc 3529, Hungary; Recruiting

Cagliari 09124, Italy; Recruiting

Monserrato 09042, Italy; Not yet recruiting

Brescia 25123, Italy; Recruiting

Catania 95124, Italy; Recruiting

Catania 95100, Italy; Not yet recruiting

Trieste 34100, Italy; Not yet recruiting

Milano 20161, Italy; Recruiting

Milano 21161, Italy; Not yet recruiting

Verona 37226, Italy; Not yet recruiting

Verona 37134, Italy; Not yet recruiting

Torino 10128, Italy; Not yet recruiting

Orbassano TO, Italy; Not yet recruiting

Roma 00161, Italy; Not yet recruiting

Perugia 06100, Italy; Not yet recruiting

Roma 00168, Italy; Recruiting

Siena 53100, Italy; Recruiting

Parma 43100, Italy; Recruiting

Seoul 110-744, Korea, Republic of; Active, not recruiting

Seoul 138-736, Korea, Republic of; Active, not recruiting

Guadalajara, Mexico; Recruiting

Mexico D.F., Mexico; Not yet recruiting

CX Voorburg 2275, Netherlands; Recruiting

GL Nijmegen 6525, Netherlands; Recruiting

HX Maastricht 6229, Netherlands; Recruiting

DD Vlissingen 4388, Netherlands; Recruiting

Bydgoszcz 85-096, Poland; Active, not recruiting

Warszawa 00-710, Poland; Active, not recruiting

Lublin 20-954, Poland; Recruiting

Warszawa 00-909, Poland; Recruiting

Porto 4099-100, Portugal; Not yet recruiting

Coimbra 3000-075, Portugal; Recruiting

Ryiad, Saudi Arabia; Not yet recruiting

Belgrade 11000, Serbia and Montenegro; Recruiting

Niska 18205, Serbia and Montenegro; Recruiting

Zemun 11080, Serbia and Montenegro; Recruiting

Novi Sad 21000, Serbia and Montenegro; Recruiting

Puerto Real 11510, Spain; Recruiting

Barcelona, Spain; Recruiting

Madrid 28034, Spain; Active, not recruiting

Las Palmas de GC 35016, Spain; Recruiting

Barcelona 08003, Spain; Active, not recruiting

San Sebastian 20014, Spain; Recruiting

Leganes 28911, Spain; Recruiting

Uppsala 751 85, Sweden; Recruiting

Umea 901 85, Sweden; Recruiting

Jonkoping 551 85, Sweden; Active, not recruiting

Zürich 8091, Switzerland; Recruiting

Lausanne 1011, Switzerland; Recruiting

Taipei, Taiwan; Recruiting

Kaohsiung County, Taiwan; Recruiting

Ankara, Turkey; Recruiting

London SE1 7EH, United Kingdom; Recruiting

London NW3 2QG, United Kingdom; Recruiting

Nuneaton CV10 7DJ, United Kingdom; Recruiting

Leeds LS1 3EX, United Kingdom; Not yet recruiting

Salford M6 8HD, United Kingdom; Recruiting

Harrogate HG2 7SX, United Kingdom; Recruiting

Cardiff CF14 4XW, United Kingdom; Recruiting

Aberdeen AB25 2Z, United Kingdom; Recruiting

Additional Information

Starting date: December 2005
Ending date: March 2008
Last updated: December 19, 2007

Page last updated: June 20, 2008

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