Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

NCT ID: NCT00482170

Last Updated: 2012-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-09-30

Brief Summary

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.

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Arm 1: Enbrel 50 mg Prefilled Syringe

Group Type: EXPERIMENTAL

Enbrel (etanercept)

Intervention Type: DEVICE

Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly

2

Arm 2 Enbrel 50 mg Autoinjector

Group Type: ACTIVE_COMPARATOR

Etanercept

Intervention Type: DEVICE

Arm 2 = Enbrel 50 mg Autoinjector twice weekly

Interventions

Enbrel (etanercept)

Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly

Intervention Type: DEVICE

Etanercept

Arm 2 = Enbrel 50 mg Autoinjector twice weekly

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

Bruges, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Edegem, , Belgium

Ghent, , Belgium

Hasselt, , Belgium

Kapellen, , Belgium

Liège, , Belgium

Hellerup, , Denmark

Hørsholm, , Denmark

Roskilde, , Denmark

Helsinki, , Finland

Helsinki, , Finland

Joensuu, , Finland

Tampere, , Finland

Le Mans, Cedex, France

Limoges, , France

Montpellier, , France

Nancy, , France

Nantes, , France

Paris, , France

Pessac, , France

Pierre-Bénite, , France

Reims, , France

Toulouse, , France

Augsburg, , Germany

Berlin, , Germany

Berlin, , Germany

Bonn, , Germany

Cologne, , Germany

Dresden, , Germany

Dülmen, , Germany

Erlangen, , Germany

Freiburg im Breisgau, , Germany

Göttingen, , Germany

Greifswald, , Germany

Hamburg, , Germany

Lübeck, , Germany

Mainz, , Germany

Mannheim, , Germany

München, , Germany

Münster, , Germany

Tübingen, , Germany

Wiesbaden, , Germany

Würzburg, , Germany

Würzburg, , Germany

Athens, , Greece

Athens, , Greece

Ioannina, , Greece

Thessaloniki, , Greece

Szeged, , Hungary

S. Giovanni Rotondo, Foggia, Italy

Terracina, Latina, Italy

Gallarate, Varese, Italy

Capranica, Viterbo, Italy

Bologna, , Italy

Como, , Italy

Milan, , Italy

Napoli, , Italy

Napoli, , Italy

Padua, , Italy

Pisa, , Italy

Breda, , Netherlands

Flushing, , Netherlands

Nijmegen, , Netherlands

Bergen, , Norway

Stavanger, , Norway

Tromsø, , Norway

Elche, Alicante, Spain

Santander, Cantabria, Spain

Córdoba, , Spain

Granada, , Spain

Madrid, , Spain

Valencia, , Spain

Danderyd, , Sweden

Gothenburg, , Sweden

Linköping, , Sweden

Malmo, , Sweden

Countries

Belgium; Denmark; Finland; France; Germany; Greece; Hungary; Italy; Netherlands; Norway; Spain; Sweden

Other Identifiers

0881A6-3326

Identifier Type: -

Identifier Source: org_study_id