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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Device: Enbrel 50 mg Autoinjector; Device: Enbrel 50 mg Prefilled Syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00459706

0881K1-6000

B1801017 (Other Identifier)

Details and patient eligibility

About

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 (RA).

Full description

This study describes 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, confidence, presence or absence of fear, side effects related to administration) is captured using a questionnaire based on the outputs of patient interviews.

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, self efficacy, expectations of treatment, perception of their illness) and RA characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).

Enrollment: 640 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

Enbrel 50 mg Prefilled Syringe

Experimental group

Description:

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe

Treatment:

Device: Enbrel 50 mg Prefilled Syringe

Enbrel 50 mg Autoinjector

Experimental group

Description:

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector

Treatment:

Device: Enbrel 50 mg Autoinjector