Study Complete
Sponsor ID
20110107
Study to Evaluate the Ability of Subjects with Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
Study Details
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®).
Protocol Summary
Primary Outcome Measures
Successful self-injection of etanercept using Autoinjector A, as evaluated by the proportion of successful injections of the total non-missed injections administered by subjects in the non–health care setting
Timeframe: Weekly for 5 weeks at Week 1, Week 2, Week 3, Week 4 and Week 5
Secondary Outcome Measures
Autoinjector A system failure when the Autoinjector A system is operated within intended use
Timeframe: Weekly for 5 weeks at Week 1, Week 2, Week 3, Week 4 and Week 5
Proportions of the unsuccessful steps in the self-injection process for unsuccessful injections, as assessed by the Participant Self-injection Questionnaire (Questions 2 to 5).
Timeframe: Weekly for 5 weeks at Week 1, Week 2, Week 3, Week 4 and Week 5
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Santa Maria, CA, United States, 93454-6945
Status
Recruiting
Location
Research Site
Duncansville, PA, United States, 16635
Status
Recruiting
Location
Research Site
Oklahoma City, OK, United States, 73103
Status
Recruiting
Location
Research Site
Upland, CA, United States, 91786
Status
Recruiting
Location
Research Site
Lincoln, NE, United States, 68516
Status
Recruiting
Location
Research Site
Orchard Park, NY, United States, 14127
Status
Recruiting
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