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

NCT00121043 Phase 4 COMPLETED

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.

Details

Lead sponsor	Amgen
Phase	Phase 4
Status	COMPLETED

Conditions

• Rheumatoid Arthritis

Interventions

• SimpleJectTM
• Kineret® (Anakinra)

Primary outcomes

• Difference in the EAQ Part B Ease of Use Subscale Score between the two injection methods