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

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis, Psoriatic Arthritis

In brief

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®).

Key facts

Study ID

NCT01901185

Run by

Amgen

People needed

77

Starts

2013-06-11

Expected to finish

2013-12-30

Last updated by the study team

2018-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — Peoria, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Santa Maria, California, United States
• Research Site — Upland, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Paducah, Kentucky, United States
• Research Site — Lincoln, Nebraska, United States
• Research Site — Orchard Park, New York, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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