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

Phase 3CompletedNCT01901185

Amgen77 enrolled

Overview

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®).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis Psoriatic Arthritis

Interventions

Etanercept / Autoinjector ADRUG

Autoinjector A, a hand-held, reusable electromechanical device, and a single-use, disposable cassette preassembled with an etanercept 50-mg liquid prefilled syringe (PFS).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

Research Site

Huntsville, Alabama, United States

Research Site

Peoria, Arizona, United States

Research Site

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Percentage of Successful Self-injections to Total Non-missed Injections

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.

Time frame: Week 1, Week 2, Week 3, Week 4 and Week 5

Secondary Outcomes

Percentage of Autoinjector A System Failures

The autoinjector A and prefilled syringe (PFS)/cassettes used by the participants were examined at the end of the study by device engineers. System failure was defined as the failure of the Autoinjector A or PFS/cassette to meet the device design requirements during Weeks 1 to 5. The percentage of system failures is reported out of the total number of injection attempts during the study, including multiple attempts per week.

Time frame: Week 1, Week 2, Week 3, Week 4 and Week 5

Percentage of Errors in Each Step of the Self-injection Process

For all the nonmissed injections recorded on the Participant Self-injection Questionnaire, the percentage of the following steps in the self-injection process that were not successfully completed out of the total nonmissed injections during Weeks 1 to 5 are reported. If multiple attempts were recorded, all the recorded attempts were considered, regardless whether it was a successful attempt or not. • Error Icon lit up (Question 2) • Could not load cassette successfully (Question 3) • Could not remove purple cassette cap successfully (Question 4) • Could not press start button to begin self-injection successfully (Question 5).

Time frame: Week 1, Week 2, Week 3, Week 4 and Week 5

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.