A Phase 3 interventional study of Etanercept / Autoinjector A in Rheumatoid Arthritis and Psoriatic Arthritis, sponsored by Amgen. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-04.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 77 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Also known as: Enbrel®
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
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
Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events
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.
Time frame: 9 weeks
Patients with rheumatoid arthritis (RA) or psoriatic arthritis (psA) currently receiving treatment with etanercept were eligible to enrol in this study. First patient enrolled on 11 June 2013; last patient enrolled on 13 November 2013.
| Milestone | Etanercept / Autoinjector A |
|---|---|
| Started | 77 |
| Received etanercept with autoinjector a | 75 |
| Completed | 75 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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 successful injections | Etanercept / Autoinjector A |
|---|---|
| Percentage of Successful Self-injections to Total Non-missed Injections | 97.8 (96.3 to 99.3) |
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 system failures | Etanercept / Autoinjector A |
|---|---|
| Percentage of Autoinjector A System Failures | 2.4 (1.0 to 4.0) |
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).
| percentage of errors | Etanercept / Autoinjector A |
|---|---|
| Error icon lit up | 4.3 |
| Could not load cassette successfully | 1.9 |
| Could not remove purple cassette cap successfully | 1.1 |
| Could not press start button to begin injection | 1.6 |
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.
| participants | Etanercept / Autoinjector A |
|---|---|
| All adverse events | 21 |
| Serious adverse events | 1 |
| Adverse events associated with device | 10 |
Collected over 9 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Autoinjector A/Etanercept | — | 1/75 (1.3%) | 14/75 (18.7%) |
| Event | Autoinjector A/Etanercept |
|---|---|
| Gastroenteritis viralInfections and infestations | 1/75 |
| Event | Autoinjector A/Etanercept |
|---|---|
| Injection site painGeneral disorders | 12/75 |
| Injection site reactionGeneral disorders | 4/75 |
| Age, Continuous(years) | Etanercept / Autoinjector A |
|---|---|
| Mean | 53.8 ± 13.7 |
| Sex: Female, Male(Participants) | Etanercept / Autoinjector A |
|---|---|
| Female | 56 |
| Male | 21 |
| Race/Ethnicity, Customized(participants) | Etanercept / Autoinjector A |
|---|---|
| Asian | 1 |
| White | 74 |
| Other | 2 |
| Race/Ethnicity, Customized(participants) | Etanercept / Autoinjector A |
|---|---|
| Hispanic/Latino | 14 |
| Not Hispanic/Latino | 63 |
| Disease state(participants) | Etanercept / Autoinjector A |
|---|---|
| Rheumatoid arthritis | 66 |
| Psoriatic arthritis | 11 |
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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