Clinical trial NCT00195507: Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis
Official title: A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.


Eligibility 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

Primary outcomes:
measure: Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
timeFrame: 54 weeks
Secondary outcomes:
measure: Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline
timeFrame: 54 weeks
measure: Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"
timeFrame: 54 weeks
measure: Number of Patients With Survey Response of "Somewhat Satisfied" or Better
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Feldkirch
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Praha 8
country: Czech Republic
city: Aarhus C
country: Denmark
city: Odense C
country: Denmark
city: Roskilde
country: Denmark
city: Kuopio
country: Finland
city: Lahti
country: Finland
city: Besancon Cedex
country: France
city: Bordeaux
country: France
city: Boulogne Billancourt
country: France
city: Brest cedex 2
country: France
city: Créteil cedex
country: France
city: Dijon Cedex
country: France
city: Lille Cedex
country: France
city: Lyon cedex 02
country: France
city: Lyon Cedex 03
country: France
city: Marseille cedex
country: France
city: Marseille Cédex 09
country: France
city: Montpellier Cédex 5
country: France
city: Nancy
country: France
city: Nantes cedex 01
country: France
city: Nice
country: France
city: Nimes Cedex 9
country: France
city: Paris
country: France
city: Pessac Cedex
country: France
city: Pierre Benite cedex
country: France
city: Poitiers
country: France
city: Reims
country: France
city: Rouen
country: France
city: Saint-Etienne
country: France
city: Strasbourg cedex
country: France
city: Toulouse Cedex
country: France
city: Tours
country: France
city: Bochum
country: Germany
city: Düsseldorf
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Münster
country: Germany
city: Nordheide
country: Germany
city: Osnabrück
country: Germany
city: Tübingen
country: Germany
city: Wurzburg
country: Germany
city: Athens
country: Greece
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Ancona
country: Italy
city: Cagliari
country: Italy
city: Genova
country: Italy
city: Modena
country: Italy
city: Padova
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Terni
country: Italy
city: Torino
country: Italy
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Capelle Aan Den Ijssel
country: Netherlands
city: Heerlen
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Voorburg
country: Netherlands
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Warszawa
country: Poland
city: Lisboa
country: Portugal
city: LIsboa
country: Portugal
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Llobregat
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Valencia
country: Spain
city: Danderyds
country: Sweden
city: Göteborg
country: Sweden
city: Linkoping
country: Sweden
city: Lund
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Geneva
country: Switzerland
city: Bornova-Izmir
country: Turkey
city: Capa-Istanbul
country: Turkey
city: Kocamustafapasa-Istanbul
country: Turkey
city: Aberdeen
country: United Kingdom
city: Airdrie
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Coventry
country: United Kingdom
city: Dublin
country: United Kingdom
city: Dundee
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Lancaster
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Newport
country: United Kingdom
city: Norwich
country: United Kingdom
city: Salford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Suffolk
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Italy,Greece, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Denmark, Finland, Sweden, Norway, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: TRial manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hungary, WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Turkey, Erisc@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, MedinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedonfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Griffiths CE, Luger TA, Brault Y, Germain JM, Mallbris L. Retreatment in patients with psoriasis achieving response with etanercept after relapse due to treatment interruption: results from the CRYSTEL study. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):468-73. doi: 10.1111/jdv.12585. Epub 2014 Aug 4.