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

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ClinicalTrials.gov Identifier: NCT01901185
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : November 21, 2014
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Rheumatoid Arthritis
Psoriatic Arthritis
Intervention Drug: Etanercept / Autoinjector A
Enrollment 77
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Etanercept / Autoinjector A
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 77
Received Etanercept With Autoinjector A 75
Completed 75
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Etanercept / Autoinjector A
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants
53.8  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants
Female
56
  72.7%
Male
21
  27.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants
Asian 1
White 74
Other 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants
Hispanic/Latino 14
Not Hispanic/Latino 63
Disease state  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants
Rheumatoid arthritis 66
Psoriatic arthritis 11
1.Primary Outcome
Title Percentage of Successful Self-injections to Total Non-missed Injections
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set defined as all nonmissed injections using Autoinjector A during Weeks 1 to 5 for all enrolled participants; in the event of multiple injection attempts, only the last attempt per week was counted.
Arm/Group Title Etanercept / Autoinjector A
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 75
Overall Number of Units Analyzed
Type of Units Analyzed: Nonmissed injections
367
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of successful injections
97.8
(96.3 to 99.3)
2.Secondary Outcome
Title Percentage of Autoinjector A System Failures
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; multiple injection attempts per week are included.
Arm/Group Title Etanercept / Autoinjector A
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 75
Overall Number of Units Analyzed
Type of Units Analyzed: Total injection attempts
373
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of system failures
2.4
(1.0 to 4.0)
3.Secondary Outcome
Title Percentage of Errors in Each Step of the Self-injection Process
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; multiple injection attempts per week are included.
Arm/Group Title Etanercept / Autoinjector A
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 75
Overall Number of Units Analyzed
Type of Units Analyzed: Total injection attempts
373
Measure Type: Number
Unit of Measure: percentage of errors
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
4.Other Pre-specified Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Etanercept / Autoinjector A
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: participants
All adverse events 21
Serious adverse events 1
Adverse events associated with device 10
Time Frame 9 weeks
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Autoinjector A/Etanercept
Hide Arm/Group Description Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week at Weeks 1 - 5 (total of 6 injections).
All-Cause Mortality
Autoinjector A/Etanercept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Autoinjector A/Etanercept
Affected / at Risk (%)
Total   1/75 (1.33%) 
Infections and infestations   
Gastroenteritis viral  1  1/75 (1.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Autoinjector A/Etanercept
Affected / at Risk (%)
Total   14/75 (18.67%) 
General disorders   
Injection site pain  1  12/75 (16.00%) 
Injection site reaction  1  4/75 (5.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01901185     History of Changes
Other Study ID Numbers: 20110107
First Submitted: May 17, 2013
First Posted: July 17, 2013
Results First Submitted: November 5, 2014
Results First Posted: November 21, 2014
Last Update Posted: September 3, 2018