Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
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®).
Drug: Etanercept / Autoinjector A
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Percentage of Successful Self-injections to Total Non-missed Injections [ Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: No ]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.
- Percentage of Autoinjector A System Failures [ Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: No ]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.
- Percentage of Errors in Each Step of the Self-injection Process [ Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: No ]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).
- Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a causal relationship with study treatment or the device under study. The definition includes worsening of a pre-existing medical condition. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening • requires or prolongs in-patient hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. An adverse device effect is any adverse event related to the use of a medical device. Adverse device effects include AEs resulting from insufficient or inadequate instructions for use, malfunction of the device, or from use errors (including errors resulting from normal use, reasonably forseeable misuse or from intentional misuse) of the device.
|Study Start Date:||June 2013|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: 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).
Drug: Etanercept / Autoinjector A
Autoinjector A, a hand-held, reusable electromechanical device, and a single-use, disposable cassette preassembled with an etanercept 50-mg liquid prefilled syringe (PFS).
Other Name: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01901185
|United States, Alabama|
|Huntsville, Alabama, United States, 35801|
|United States, Arizona|
|Peoria, Arizona, United States, 85381|
|Phoenix, Arizona, United States, 85037|
|United States, California|
|Santa Maria, California, United States, 93454-6945|
|Upland, California, United States, 91786|
|United States, Colorado|
|Denver, Colorado, United States, 80230|
|United States, Florida|
|Sarasota, Florida, United States, 34239|
|Tampa, Florida, United States, 33614|
|United States, Kentucky|
|Paducah, Kentucky, United States, 42003|
|United States, Nebraska|
|Lincoln, Nebraska, United States, 68516|
|United States, New York|
|Orchard Park, New York, United States, 14127|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73103|
|United States, Pennsylvania|
|Duncansville, Pennsylvania, United States, 16635|