Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

Condition(s) targeted: Psoriasis

Intervention: Enbrel (etanercept) (Device); Etanercept (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

Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied. Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.

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 Auto-Injector and the Etanercept Prefilled Syringe) in Patients With Psoriasis.

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment

Primary outcome: Compare patient satisfaction with 2 injection devices (PFS - AutoInjector) will be measured by asking patients: "How satisfied are you with your injection device?": using a 10 point scale

Secondary outcome: Device attributes and patient perception : Ease of use and convenience of injection device operation Confidence in the device -Presence or absence of fear of the device-Device characteristics -Side effects related to administration- Anxiety measure

Detailed description: For the measures of patient's satisfaction with and perceptions of, their device, standard Likert scales are used. This allows the magnitude of individual's perceptions and satisfaction to be measured on a multipoint scale anchored at each end. In addition, the study will describe patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e. g. ease of use, convenience, injection site pain, injection anxiety, injection confidence) will be captured using a questionnaire. 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, demographics, social and educational status psychological status, willingness to self-manage, injection experience) and Psoriasis characteristics (e. g. disease severity, disease duration, co morbidities, prior treatment, quality of life). The study will also take the opportunity to measure health outcome measures as there may be important differences in cost of training and patient support between the two devices.

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

Criteria:

Inclusion Criteria:

- Treatment of adults with moderate to severe plaque psoriasis who failed to respond to,

or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA

- Eligible for treatment with etanercept according to Summary of Product Characteristics

(SmPC), and applicable local guidelines.

- Aged 18 years or more

- Willing and able to self-inject etanercept.

- Able to store test drug at 2-8oC.

- Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week

0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.

- Capable of understanding and willing to provide signed and dated written voluntary

informed consent before any protocol-specific procedures are performed.

Exclusion Criteria:

- Prior experience of biologics and anti-TNF treatment for their Psoriasis including

etanercept.

- Sepsis or risk of sepsis.

- Current or recent infections, including chronic or localized.

- Latex sensitivity.

- Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination

during the course of the study.

Trial Manager, Email: clintrialparticipation@wyeth.com

Gent 09000, Belgium; Not yet recruiting

Liège 1 B-4000, Belgium; Not yet recruiting

Brugge 08000, Belgium; Recruiting

Bruxelles 01200, Belgium; Recruiting

Bruxelles 01070, Belgium; Not yet recruiting

Edegem B-2650, Belgium; Not yet recruiting

Hasselt 03500, Belgium; Not yet recruiting

Kapellen 02950, Belgium; Suspended

Roskilde 04000, Denmark; Not yet recruiting

Hellerup 02900, Denmark; Not yet recruiting

Hørsholm 02970, Denmark; Terminated

Helsinki 00250, Finland; Not yet recruiting

Helsinki 00029 HUS, Finland; Not yet recruiting

Tampere FIN-33521, Finland; Recruiting

Joensuu 802 10, Finland; Recruiting

Toulouse 31059, France; Recruiting

Limoges 87042, France; Recruiting

Reims 51092, France; Recruiting

Pessac 33600, France; Recruiting

Paris 75010, France; Recruiting

Montpellier 34000, France; Not yet recruiting

Pierre Bénite 69495, France; Recruiting

Nancy 54000, France; Not yet recruiting

Nantes 44093, France; Recruiting

Augsburg 86179, Germany; Recruiting

Erlangen 91052, Germany; Not yet recruiting

Mannheim 68135, Germany; Not yet recruiting

Mainz 55101, Germany; Recruiting

Bonn 53105, Germany; Not yet recruiting

Muenster 48149, Germany; Recruiting

Greifswald 17475, Germany; Not yet recruiting

Wiesbaden 65199, Germany; Recruiting

Luebeck 23538, Germany; Not yet recruiting

Koeln 50931, Germany; Not yet recruiting

Muenchen 80802, Germany; Recruiting

Hamburg 20246, Germany; Not yet recruiting

Duelmen 48249, Germany; Recruiting

Wuerzburg D-97080, Germany; Not yet recruiting

Augsburg 86179, Germany; Not yet recruiting

Freiburg 79106, Germany; Recruiting

Tübingen 72076, Germany; Not yet recruiting

Berlin 10435, Germany; Recruiting

Goettingen 37099, Germany; Not yet recruiting

Dresden 01307, Germany; Not yet recruiting

Wuerzburg 97070, Germany; Not yet recruiting

Berlin 10827, Germany; Recruiting

Ioannina 45332, Greece; Not yet recruiting

Athens, Greece; Not yet recruiting

Thessaloniki 54644, Greece; Not yet recruiting

Athens 54644, Greece; Not yet recruiting

Szeged 06720, Hungary; Terminated

Padova, Italy; Terminated

Como 22100, Italy; Terminated

Milano 20122, Italy; Terminated

Pisa 56126, Italy; Terminated

Bologna 40128, Italy; Terminated

Napoli 80132, Italy; Terminated

Napoli 80131, Italy; Terminated

Breda 4818 CK, Netherlands; Recruiting

Vlissingen 4382 EE, Netherlands; Not yet recruiting

Nijmegen 06525, Netherlands; Not yet recruiting

Tromso N-9038, Norway; Not yet recruiting

Stavanger 04068, Norway; Not yet recruiting

Bergen 05021, Norway; Not yet recruiting

Madrid SPAIN 28046, Spain; Not yet recruiting

Valencia 46015, Spain; Not yet recruiting

Granada 18012, Spain; Not yet recruiting

Córdoba 14004, Spain; Not yet recruiting

Danderyd 182 88, Sweden; Recruiting

Linköping SE-581 85, Sweden; Recruiting

Malmö SE-205 02, Sweden; Recruiting

Göteborg 41459, Sweden; Recruiting

Elche, Alicante 03203, Spain; Recruiting

Santander, Cantabria 39008, Spain; Recruiting

Le Mans, Cedex 72037, France; Recruiting

S. Giovanni Rotondo, Foggia 71013, Italy; Terminated

Terracina, Latina ITALY 04019, Italy; Terminated

Gallarate, Varese 21013, Italy; Terminated

Capranica, Viterbo 01012, Italy; Terminated

Starting date: September 2007
Ending date: April 2009
Last updated: July 25, 2008