The primary purpose of this study is to assess the ease-of-use of SimpleJectTM compared to pre-filled syringe(s) when using Kineret® in RA subjects. The secondary purpose of this study is to assess the level of fear and anxiety associated with the use of both injection methods, to assess safety when using SimpleJectTM and to evaluate the Ease-of-Administration Questionnaire (EAQ) in terms of the quality of items, item performance, and the instrument reliability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Difference in the EAQ Part B Ease of Use Subscale Score between the two injection methods
Difference between the two injection methods for the following
EAQ Part B Total Score.
EAQ Part B Overall Satisfaction Subscale Score.
EAQ Part B Anxiety/Fear of Needles Subscale Score.
EAQ Part B Confidence in Ability of Use Subscale Score.
EAQ Part B Pain/Discomfort Subscale Score.
EAQ Part C Total Preference Score.
EAQ Quality Measures.
EAQ Item Performance Measures.
EAQ Instrument Reliability Measures.
Incidence and severity of AE's.
Incidence of concomitant medications.
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