Study Comparing Satisfaction and Perceptions for Two Different Delivery Mechanisms for Rheumatoid Arthritis Patients Administered 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 Autoinjector and the Etanercept prefilled syringe) in patients with rheumatoid arthritis.

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, Uncontrolled, 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

Linz 04040, Austria; Recruiting

Bludenz 06700, Austria; Terminated

Wien 01100, Austria; Recruiting

Gent 09000, Belgium; Recruiting

Sijsele-Damme 08340, Belgium; Active, not recruiting

Oostende 08400, Belgium; Recruiting

Hasselt 03500, Belgium; Recruiting

Diepenbeek 03590, Belgium; Recruiting

Montignies sur Sambre 06061, Belgium; Recruiting

Mechelen 02800, Belgium; Recruiting

Thessaloniki 55139, Greece; Recruiting

Heraklion 715 00, Greece; Not yet recruiting

Thessaloniki 55134, Greece; Recruiting

Castellon de la Plana 12004, Spain; Recruiting

Barcelona 8041, Spain; Recruiting

Córdoba 14004, Spain; Terminated

Lugo 27004, Spain; Recruiting

Madrid 28006, Spain; Recruiting

Madrid 28034, Spain; Recruiting

Madrid 28007, Spain; Recruiting

Málaga 29010, Spain; Not yet recruiting

Valencia 46017, Spain; Not yet recruiting

Zurich 08091, Switzerland; Recruiting

Bern 03010, Switzerland; Recruiting

Morges 01110, Switzerland; Terminated

Yverdon-les-Bains 01400, Switzerland; Active, not recruiting

Geneve 01211, Switzerland; Recruiting

Basel 04012, Switzerland; Recruiting

St Gallen 09007, Switzerland; Recruiting

Chur 7000, Switzerland; Recruiting

Marousi, Attiki 15123, Greece; Recruiting

Jerez de la Frontera, Cádiz 11407, Spain; Not yet recruiting

San Sebastián, Guipúzcua 20014, Spain; Recruiting

Graz, Styria 08020, Austria; Recruiting

Basurto, Vizcaya 48103, Spain; Recruiting

Starting date: November 2007
Ending date: April 2009
Last updated: January 20, 2009