Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
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
1 other identifier
interventional
77
1 country
13
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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 rheumatoid-arthritis
Started Jun 2013
Shorter than P25 for phase_3 rheumatoid-arthritis
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2013
CompletedStudy Start
First participant enrolled
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2013
CompletedResults Posted
Study results publicly available
November 21, 2014
CompletedSeptember 4, 2018
August 1, 2018
6 months
May 17, 2013
November 5, 2014
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 1, Week 2, Week 3, Week 4 and Week 5
Secondary Outcomes (2)
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
Other Outcomes (1)
Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events
9 weeks
Study Arms (1)
Etanercept / Autoinjector A
EXPERIMENTALParticipants 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).
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (13)
Research Site
Huntsville, Alabama, 35801, United States
Research Site
Peoria, Arizona, 85381, United States
Research Site
Phoenix, Arizona, 85037, United States
Research Site
Santa Maria, California, 93454-6945, United States
Research Site
Upland, California, 91786, United States
Research Site
Denver, Colorado, 80230, United States
Research Site
Sarasota, Florida, 34239, United States
Research Site
Tampa, Florida, 33614, United States
Research Site
Paducah, Kentucky, 42003, United States
Research Site
Lincoln, Nebraska, 68516, United States
Research Site
Orchard Park, New York, 14127, United States
Research Site
Oklahoma City, Oklahoma, 73103, United States
Research Site
Duncansville, Pennsylvania, 16635, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2013
First Posted
July 17, 2013
Study Start
June 11, 2013
Primary Completion
December 18, 2013
Study Completion
December 30, 2013
Last Updated
September 4, 2018
Results First Posted
November 21, 2014
Record last verified: 2018-08