A Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject Etanercept
Overview
- Phase
- Phase 3
- Intervention
- Etanercept / Autoinjector A
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Amgen
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Percentage of Successful Self-injections to Total Non-missed Injections
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 screening period and a 5-week treatment period.
Investigators
Eligibility 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.
Arms & Interventions
Etanercept / Autoinjector A
Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
Intervention: Etanercept / Autoinjector A
Outcomes
Primary Outcomes
Percentage of Successful Self-injections to Total Non-missed Injections
Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 5
The successful self-injection of etanercept using the Autoinjector A, as evaluated by the percentage of successful injections of the total nonmissed injections administered by participants in the non-health care setting during Weeks 1 to 5. Successful self-injection was assessed by Question 1 in the Participant Self-injection Questionnaire, which was completed by each participant after each self-injection. Successful injection is defined as the Autoinjector A signaling a complete injection and no liquid medication pooled on your skin.
Secondary Outcomes
- Percentage of Autoinjector A System Failures(Week 1, Week 2, Week 3, Week 4 and Week 5)
- Percentage of Errors in Each Step of the Self-injection Process(Week 1, Week 2, Week 3, Week 4 and Week 5)