Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept
NCT ID: NCT00992394
Last Updated: 2016-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
174 participants
INTERVENTIONAL
2010-01-31
2013-04-30
Brief Summary
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The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Subjects randomized to arm 1 stop their etanercept treatment on entry into the study and may be retreated by etanercept 50 mg once weekly after medical review and agreement between the subject and the investigator
etanercept
etanercept 50 mg once weekly as requested.
Arm 2
Subjects randomized to arm 2 in which subjects continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the subject and the investigator
etanercept
etanercept 25 mg or 50 mg as requested.
Interventions
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etanercept
etanercept 50 mg once weekly as requested.
etanercept
etanercept 25 mg or 50 mg as requested.
Eligibility Criteria
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Inclusion Criteria
* Previously treated with etanercept for chronic plaque psoriasis for at least 12 weeks prior to the screening visit and received a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit
* Having shown clinical response with a PGA inferior or equal to 1 at the screening visit.
* PGA inferior or equal to 1 at the baseline visit.
Exclusion Criteria
* Evidence of active or previously known medical history of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis).
* Any biologics other than etanercept within the 20 weeks prior to the screening visit.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Clinica Dermatologica - Universita' di Catania
Catania, , Italy
Centro di Ricerca Clinica Fondazione Universita' degli Studi Gabriele D'Annunzio
Chieti, , Italy
U.O. Dermatologia
Parma, , Italy
Hospital General Universitario Alicante C/ Maestro Alonso, 1
Alicante, Alicante, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Fundacion Hospital Alcorcon
Alcorcón, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Virgen de la VICTORIA
Málaga, Malaga, Spain
Istanbul Universitesi
Istanbul, Capa, Turkey (Türkiye)
Gulhane Askeri Tip Akademisi Tip Fakultesi
Ankara, Etlik, Turkey (Türkiye)
Gulhane Askeri Tip Fakultesi
Ankara, Etlik, Turkey (Türkiye)
Gulhane Military Medical Academy, Faculty of Medicine
Ankara, Etlik, Turkey (Türkiye)
Bezm-i Alem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, Fatih, Turkey (Türkiye)
Uludag Universitesi
Bursa, Gorukle, Turkey (Türkiye)
T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
Pendik, Istanbul, Turkey (Türkiye)
Gazi Universitesi
Ankara, Sihhiye, Turkey (Türkiye)
Hacettepe Universitesi
Ankara, Sihhiye, Turkey (Türkiye)
Hacettepe Universitesi
Ankara, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Dermatoloji Anabilim Dali
Bornova / Izmir, , Turkey (Türkiye)
Sheikh Khalifa Medical City
Abu Dhabi, UAE, United Arab Emirates
Harrogate District Hospital
Harrogate, Harrogate, United Kingdom
Whipps Cross Hospital
London, , United Kingdom
Centre Hopitalier St Jacques (Place St Jacques)
Besançon, , France
CHU Dupuytren
Limoges, , France
Service de Chirurgie Infantile
Lyon, , France
C.H.U Nantes
Nantes, , France
CHU de l Archet
Nice, , France
Hopital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
C.H.U de Reims
Reims, , France
Hôpital Purpan
Toulouse, , France
Klinik fuer Dermatologie, Allergologie und Venerologie
Berlin, , Germany
St. Josef-Klinikum
Bochum, , Germany
Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
Erlangen, , Germany
J. W. Goethe Universitaet Frankfurt, Zentrum fuer Dermatologie und Venerologie
Frankfurt am Main, , Germany
Klinikum der Albert-Ludwigs-Universitaet
Freiburg im Breisgau, , Germany
Universitätsklinikum-Eppendorf Martinistr. 20, Hamburg 20158
Hamburg, , Germany
Dermatologische Gemeinschaftspraxis Rosenbach
Osnabrück, , Germany
"Andreas Sygros" Hospital
Athens, , Greece
Papageorgiou General Peripheral Hospital of Thessaloniki
Thessaloniki, , Greece
Semmelweis Egyetem, Bor-, Nemikortani es Boronkologiai Klinika
Budapest, , Hungary
Debreceni Egyetem Orvos-és Egészségtudományi Centrum
Debrecen, , Hungary
Miskolci Egeszsegugyi Kozpont
Miskolc, , Hungary
SZTE, Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
Szeged, , Hungary
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1801021
Identifier Type: OTHER
Identifier Source: secondary_id
2008-004439-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0881X1-4535
Identifier Type: -
Identifier Source: org_study_id
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