Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

Pfizer

Status and phase

Completed

Phase 3

Conditions

Psoriasis

Treatments

Device: Enbrel (etanercept)

Device: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00482170

0881A6-3326

Details and patient eligibility

About

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.

Full 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.

Enrollment

421 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.