Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

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

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.

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.

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

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

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