Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept

• Status: Completed
• Trial end date: 2013-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept (Enbrel®).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Subject has diagnosis of RA or PsA and indicated for treatment with etanercept per the current label, based on history.

• Subject is willing to self-inject per investigator judgement at screening.

• Subject has no known history of tuberculosis.

Exclusion Criteria:

• Latex allergy.

• Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first study dose of etanercept.

• Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.

• Other criteria may apply.