Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
NCT ID: NCT00459706
Last Updated: 2013-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
640 participants
INTERVENTIONAL
2007-09-30
2009-09-30
Brief Summary
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Detailed Description
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The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, self efficacy, expectations of treatment, perception of their illness) and RA characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enbrel 50 mg Prefilled Syringe
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
Enbrel 50 mg Prefilled Syringe
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
Enbrel 50 mg Autoinjector
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
Enbrel 50 mg Autoinjector
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
Interventions
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Enbrel 50 mg Prefilled Syringe
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
Enbrel 50 mg Autoinjector
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
Eligibility Criteria
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Inclusion Criteria
* Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
* Willing and able to self-inject etanercept.
Exclusion:
* Prior experience of biologics and anti-TNF treatment for their RA including etanercept.
* Sepsis or risk of sepsis.
* Current or recent infections, including chronic or localized.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Frederiksberg, , Denmark
Hjørring, , Denmark
Holbæk, , Denmark
Silkeborg, , Denmark
Helsinki, , Finland
Hyvinkää, , Finland
Joensuu, , Finland
Lohja, , Finland
Amiens, , France
Aulnay-sous-Bois, , France
Avignon, , France
Boulogne-Billancourt, , France
Brest, , France
Cahors, , France
Corbeilles-Essonnes, , France
Grenoble, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Montpellier, , France
Niort, , France
Orléans, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Reims, , France
Rouen, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Erlangen, Bay, Germany
Frankfurt am Main, Hesse, Germany
Pirna, Saxony, Germany
Bad Abbach, , Germany
Bad Nauheim, , Germany
Berlin, , Germany
Berlin, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Erlangen, , Germany
Essen, , Germany
Göttingen, , Germany
Hanover, , Germany
Hanover, , Germany
Hofheim/Taunus, , Germany
Leipzig, , Germany
München, , Germany
Nienburg, , Germany
Oberammergau, , Germany
Osnabrück, , Germany
Tübingen, , Germany
Villingen-Schwenningen, , Germany
Würzburg, , Germany
Zeven, , Germany
Ariano Irpino, Avellino, Italy
S. Pietro Vernotico, Brescia, Italy
San Cesario di Lecce, Lecce, Italy
Alessandria, , Italy
Bologna, , Italy
Cagliari, , Italy
Cinisello Balsamo, , Italy
Como, , Italy
Coppito, , Italy
Fano, , Italy
Ferrara, , Italy
Foggia, , Italy
Massa, , Italy
Milan, , Italy
Napoli, , Italy
Napoli, , Italy
Padua, , Italy
Palermo, , Italy
Parma, , Italy
Reggio Calabria, , Italy
Rieti, , Italy
Roma, , Italy
Roma, , Italy
S. Dona Di Piave, , Italy
Terni, , Italy
Torino, , Italy
Torrette Di Ancona, , Italy
Verona, , Italy
Vimercate, , Italy
Arnhem, , Netherlands
Eindhoven, , Netherlands
Rotterdam, , Netherlands
Gjettum, , Norway
Harstad, , Norway
Kristiansand, , Norway
Lillehammer, , Norway
Skien, , Norway
Trondheim, , Norway
Tønsberg, , Norway
Danderyd, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Uppsala, , Sweden
Vasterås, , Sweden
Västerås, , Sweden
Ashford, , United Kingdom
Basingstoke, , United Kingdom
Cambridge, , United Kingdom
Chertsey, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Portsmouth, , United Kingdom
Southampton, , United Kingdom
Stoke-on-Trent, , United Kingdom
Truro, , United Kingdom
Westcliff-on-Sea, , United Kingdom
Wigan, , United Kingdom
Countries
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Other Identifiers
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B1801017
Identifier Type: OTHER
Identifier Source: secondary_id
0881K1-6000
Identifier Type: -
Identifier Source: org_study_id
NCT00595452
Identifier Type: -
Identifier Source: nct_alias
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