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

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).

• Device: Enbrel 50 mg Prefilled Syringe
  Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
• Device: Enbrel 50 mg Autoinjector
  Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector

• Experimental: Enbrel 50 mg Prefilled Syringe
  Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
  Intervention: Device: Enbrel 50 mg Prefilled Syringe
• Experimental: Enbrel 50 mg Autoinjector
  Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
  Intervention: Device: Enbrel 50 mg Autoinjector

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.