Status:
COMPLETED
Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
Lead Sponsor:
Amgen
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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®).
Detailed Description
Study participants need to have been self-administering etanercept for greater than or equal to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a 4-week screeni...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2013
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01901185
Start Date
June 11 2013
End Date
December 30 2013
Last Update
September 4 2018
Active Locations (13)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
Peoria, Arizona, United States, 85381
3
Research Site
Phoenix, Arizona, United States, 85037
4
Research Site
Santa Maria, California, United States, 93454-6945