Clinical trial NCT01901185: Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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®).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Successful Self-injections to Total Non-missed Injections
timeFrame: Week 1, Week 2, Week 3, Week 4 and Week 5
Secondary outcomes:
measure: Percentage of Autoinjector A System Failures
timeFrame: Week 1, Week 2, Week 3, Week 4 and Week 5
measure: Percentage of Errors in Each Step of the Self-injection Process
timeFrame: Week 1, Week 2, Week 3, Week 4 and Week 5
Other outcomes:
measure: Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events
timeFrame: 9 weeks
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Santa Maria
country: United States
facility: Research Site
state: California
city: Upland
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Orchard Park
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: