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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901185
• Other study ID #: 20110107
• Status: Completed
• Phase: Phase 3
• Start date: June 11, 2013
• Est. completion date: December 30, 2013

Study information

• Verified date: August 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 30, 2013
• Est. primary completion date: December 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis

Intervention

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).

Locations

Country	Name	City	State
United States	Research Site	Denver	Colorado
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Huntsville	Alabama
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orchard Park	New York
United States	Research Site	Paducah	Kentucky
United States	Research Site	Peoria	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Santa Maria	California
United States	Research Site	Sarasota	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	9 weeks
Primary	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	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.	Week 1, Week 2, Week 3, Week 4 and Week 5
Secondary	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).	Week 1, Week 2, Week 3, Week 4 and Week 5

External Links

•   AmgenTrials clinical trials website