Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Etanercept (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Italy,Greece, decresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Denmark, Finland, Sweden, Norway, MedInfoNord@wyeth.com
TRial manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Austria, WPVIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Hungary, WPBUMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Turkey, Erisc@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, MedinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For UK, ukmedonfo@wyeth.com
Summary
This study will provide a direct comparison of 'continuous therapy' and 'intermittent
therapy' with withdrawal and retreatment upon return of psoriasis.
Clinical Details
Official title: A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Compare the efficacy of continuous versus intermittent etanercept treatment regimens over 54 weeks in subjects with psoriasis
Secondary outcome: Compare the effectiveness of two etanercept (ETN) treatment regimens as measured by patient reported outcomes.Compare the time course of initial treatment response of the two ETN treatment regimens. Evaluate the safety and tolerability profile of the two ETN treatment regimens.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Stable, active plaque psoriasis
- Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine,
PUVA or Fumarate
Exclusion Criteria:
- Evidence of skin conditions other than psoriasis that would interfere with evaluations
of the effect of the study
- Systemic psoriasis therapy within 28 days prior
Locations and Contacts
Wien 1090, Austria
Feldkirch, Austria
Wien 1160, Austria
Liege 4000, Belgium
Bruxelles B-1200, Belgium
Bruxelles B-1070, Belgium
Edegem B-2650, Belgium
Gent B-9000, Belgium
Leuven B-3000, Belgium
Praha 8 180 01, Czech Republic
Aarhus C 8000, Denmark
Roskilde 4000, Denmark
Odense C 5000, Denmark
Lahti 151 70, Finland
Kuopio 702 11, Finland
Lyon Cedex 03 69437, France
Montpellier Cédex 5 34000, France
Nimes Cedex 9 30029, France
Pessac Cedex 33600, France
Brest cedex 2 29609, France
Nantes cedex 01 44093, France
Bordeaux 33075, France
Lyon cedex 02 60002, France
Paris 75018, France
Tours 37044, France
Boulogne Billancourt 92104, France
Créteil cedex 94000, France
Toulouse Cedex 31059, France
Marseille cedex 13915, France
Saint-Etienne 42055, France
Poitiers 86000, France
Besancon Cedex 25030, France
Rouen 76000, France
Dijon Cedex 21079, France
Pierre Benite cedex 69495, France
Nice 06200, France
Lille Cedex 59037, France
Reims 51092, France
Strasbourg cedex 6700, France
Nancy 54000, France
Marseille Cédex 09 13009, France
Bochum 44791, Germany
Magdeburg 39120, Germany
Wurzburg 97080, Germany
Essen 45147, Germany
Kiel 24105, Germany
Tübingen 72076, Germany
Mainz D-55101, Germany
Leipzig 04103, Germany
Nordheide 21244, Germany
Hamburg 20158, Germany
Frankfurt 60590, Germany
Münster 48149, Germany
Osnabrück 48149, Germany
Düsseldorf 40225, Germany
Erlangen 91052, Germany
Athens, Greece
Athens 124 62, Greece
Thessaloniki 54636, Greece
Budapest 1135, Hungary
Modena 41100, Italy
Cagliari 09124, Italy
Roma 00168, Italy
Padova 35100, Italy
Ancona 60020, Italy
Roma 00185, Italy
Torino, Italy
Terni 05100, Italy
Roma 00133, Italy
Pavia 27100, Italy
Genova 16132, Italy
Amsterdam 1105 - AZ, Netherlands
Nijmegen 6525 GL, Netherlands
Rotterdam 1081 HV, Netherlands
Capelle Aan Den Ijssel 2906 ZC, Netherlands
Heerlen 6419 PC, Netherlands
Voorburg 2275 CX, Netherlands
Utrecht 3584 CX, Netherlands
Amsterdam 1081 HV, Netherlands
Oslo 0407, Norway
Stavanger 4068, Norway
Bergen 5021, Norway
Warszawa 02-008, Poland
LIsboa 1169-100, Portugal
Lisboa 1069-166, Portugal
Bilbao 48009, Spain
Valencia 46014, Spain
Madrid 28006, Spain
Madrid 28007, Spain
Madrid 28041, Spain
Llobregat 8907, Spain
Barcelona 08915, Spain
Malaga 29010, Spain
Stockholm 171 76, Sweden
Göteborg 413 45, Sweden
Danderyds 182 88, Sweden
Lund 221 85, Sweden
Umea 901 85, Sweden
Linkoping 581 85, Sweden
Geneva 1205, Switzerland
Bern 3010, Switzerland
Basel 4056, Switzerland
Kocamustafapasa-Istanbul 34122, Turkey
Capa-Istanbul 34390, Turkey
Bornova-Izmir 35100, Turkey
Dundee DD1 9SY, United Kingdom
Sheffield 1OUK - S10, United Kingdom
Birmingham, United Kingdom
Liverpool, United Kingdom
London W 12, United Kingdom
Salford M6 8HD, United Kingdom
Suffolk IP4 5PD, United Kingdom
Airdrie ML6 0JS, United Kingdom
Leicester LE1 5WW, United Kingdom
London NW3 2QG, United Kingdom
Newport, United Kingdom
Newcastle Upon Tyne NE1 4LP, United Kingdom
London SE1 7EH, United Kingdom
Cardiff CF14 4XW, United Kingdom
Coventry CV2 2DX, United Kingdom
Glasgow G11 6NT, United Kingdom
London E11 1NR, United Kingdom
Norwich NR4 7UY, United Kingdom
Dublin, United Kingdom
Aberdeen AB25 1LD, United Kingdom
Leeds LS1 3EX, United Kingdom
Lancaster LA1 4RP, United Kingdom
Additional Information
Starting date: December 2004
Ending date: February 2007
Last updated: May 31, 2007
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