Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire
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.
Drug: Kineret® (Anakinra)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Randomized, Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringe(s) Using Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using A Self-Reported Questionnaire|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121043