Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

Condition(s) targeted: Active Rheumatoid Arthritis

Intervention: Etanercept Prefilled Syringe (Device); Etanercept Autoinjector (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Auto-injector and the Etanercept prefilled syringe) in patients with rheumatoid arthritis (RA).

Official title: A 3-Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore and Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector and The Etanercept Prefilled Syringe) in Patients With Rheumatoid Arthritis

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: Perception and satisfaction

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion:

- Diagnosis of RA according to the ACR-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.

Trial Manager, Email: clintrialparticipation@wyeth.com

Hjorring 09800, Denmark; Not yet recruiting

Frederiksberg 02000, Denmark; Not yet recruiting

Silkeborg DK-8600, Denmark; Not yet recruiting

Holbaek 04300, Denmark; Not yet recruiting

Hyvinkaa 05800, Finland; Not yet recruiting

Helsinki 00130, Finland; Not yet recruiting

Lohja 08200, Finland; Terminated

Joensuu 802 10, Finland; Not yet recruiting

Orléans 45032, France; Recruiting

Lille 59037, France; Recruiting

PARIS 75013, France; Not yet recruiting

Boulogne Billancourt 92104, France; Not yet recruiting

Toulouse 31054, France; Not yet recruiting

Vandoeuvre-les-Nancy 54511, France; Not yet recruiting

Montpellier 34059, France; Recruiting

Aulnay-sous-Bois 93602, France; Not yet recruiting

Avignon 84000, France; Recruiting

Reims 51092, France; Not yet recruiting

Amiens 80054, France; Recruiting

Grenoble 38043, France; Not yet recruiting

Marseille 13008, France; Recruiting

Corbeilles-Essonnes 91100, France; Recruiting

Cahors 49000, France; Recruiting

Lyon 69091, France; Not yet recruiting

PARIS 75018, France; Terminated

Montpellier 34000, France; Recruiting

Brest 29609, France; Not yet recruiting

Pierre-Bénite 69495, France; Recruiting

Rouen 76031, France; Recruiting

Niort 79021, France; Not yet recruiting

Bad Abbach 93077, Germany; Not yet recruiting

Oberammergau 82487, Germany; Recruiting

Tübingen 72076, Germany; Not yet recruiting

Bad Nauheim 61231, Germany; Not yet recruiting

Muenchen 80336, Germany; Not yet recruiting

Nienburg 31582, Germany; Not yet recruiting

Leipzig 04103, Germany; Not yet recruiting

Berlin 10777, Germany; Not yet recruiting

Goettingen 37075, Germany; Not yet recruiting

Erlangen 91056, Germany; Not yet recruiting

Hannover 30161, Germany; Not yet recruiting

Wuerzburg 97080, Germany; Not yet recruiting

Essen 45326, Germany; Not yet recruiting

Osnabrueck 49074, Germany; Recruiting

Hofheim/Taunus 65719, Germany; Not yet recruiting

Hannover 30159, Germany; Not yet recruiting

Köln 50924, Germany; Terminated

Berlin 13125, Germany; Not yet recruiting

Zeven 27404, Germany; Not yet recruiting

Duesseldorf 40211, Germany; Not yet recruiting

Villingen-Schwenningen 78034, Germany; Not yet recruiting

Napoli 80137, Italy; Terminated

Napoli 80144, Italy; Terminated

Reggio Calabria 89133, Italy; Terminated

Palermo 90100, Italy; Terminated

Foggia 71100, Italy; Terminated

Roma 00189, Italy; Terminated

Rieti 02100, Italy; Terminated

Roma 00165, Italy; Terminated

Cagliari 09042, Italy; Terminated

Alessandria 15100, Italy; Terminated

Torino 10128, Italy; Terminated

Como 22100, Italy; Terminated

Milano 20124, Italy; Terminated

Cinisello Balsamo 20099, Italy; Terminated

Vimercate 20059, Italy; Terminated

Padova 35128, Italy; Terminated

S. Dona di Piave 30027, Italy; Terminated

Parma 43100, Italy; Terminated

Ferrara 44100, Italy; Terminated

Verona 37134, Italy; Terminated

Bologna 40133, Italy; Terminated

Fano 61032, Italy; Terminated

Terni 05100, Italy; Terminated

Coppito 67010, Italy; Terminated

Massa 54100, Italy; Terminated

Torrette di Ancona 60020, Italy; Terminated

Arnhem 6815 AD, Netherlands; Recruiting

Eindhoven 5631 BM, Netherlands; Recruiting

Rotterdam 3078 HT, Netherlands; Recruiting

Lillehammer 02609, Norway; Not yet recruiting

Trondheim NO-7030, Norway; Not yet recruiting

Gjettum 01346, Norway; Not yet recruiting

Skien 03722, Norway; Not yet recruiting

Kristiansand 04615, Norway; Not yet recruiting

Harstad 09480, Norway; Not yet recruiting

TØNSBERG 03118, Norway; Not yet recruiting

Malmö SE-205 02, Sweden; Recruiting

Danderyd 182 88, Sweden; Terminated

Västerås 72189, Sweden; Recruiting

Vasterås 721 89, Sweden; Completed

Stockholm 11152, Sweden; Terminated

Sundsvall 851 86, Sweden; Recruiting

Uppsala 75185, Sweden; Recruiting

Wigan WN6 9EP, United Kingdom; Not yet recruiting

Manchester M13 9WL, United Kingdom; Not yet recruiting

Southampton SO16 6YD, United Kingdom; Terminated

Portsmouth PO6 3LY, United Kingdom; Not yet recruiting

Truro TR1 3LJ, United Kingdom; Not yet recruiting

London SE1 9RT, United Kingdom; Not yet recruiting

Stoke on Trent, United Kingdom; Terminated

Basingstoke RG24 9NA, United Kingdom; Not yet recruiting

Ashford TW15 3AA, United Kingdom; Not yet recruiting

Chertsey KT16 0PZ, United Kingdom; Not yet recruiting

London E1 4DG, United Kingdom; Not yet recruiting

Cambridge CB2 2QQ, United Kingdom; Not yet recruiting

Westcliff on Sea SS0 0RY, United Kingdom; Not yet recruiting

Ariano Irpino, Avellino 83031, Italy; Terminated

Erlangen, Bay 91054, Germany; Not yet recruiting

S. Pietro Vernotico, Brescia 72027, Italy; Terminated

Frankfurt, Hessen 60590, Germany; Recruiting

San Cesario di Lecce, Lecce 73016, Italy; Terminated

Pirna, Sachsen 01796, Germany; Not yet recruiting

Starting date: September 2007
Ending date: January 2009
Last updated: July 7, 2008