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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Device: SimpleJectTM  Drug: Kineret® (Anakinra)	Phase IV

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects must be diagnosed with RA as guided by ACR criteria
• Subjects must have an inadequate response to methotrexate alone
• Subjects must receive concomitant treatment with methotrexate during the study period
• Before any study specific procedure, the subject must give informed consent for participation in the study

Exclusion Criteria:

• Subject has previous experience using SimpleJectTM
• Prior treatment with Kineret® and/or etanercept
• Less than 6 weeks wash-out period for patients receiving prior infliximab treatment
• Subject is currently enrolled in other clinical trial, is receiving other investigational agent(s), or at least a 30 day period has not elapsed since completion of other investigational trials with device(s) or drug(s)
• Subject currently has an infection requiring systemic anti-infective therapy
• Baseline neutropenia (less than 1.5 x 10^9/l)
• Subjects with severe renal impairment (CLCR less than 30 ml/minute)
• Subjects not willing to use adequate birth control methods
• Women of childbearing potential who are pregnant, are breast-feeding or plan on becoming pregnant during the study
• Planned administration of live vaccines during study period
• Subject is not available for follow-up assessments
• Subjects with a known sensitivity to Kineret® or any of the excipients of E. coli derived proteins
• Pre-existing malignancies
• Any other condition that in the investigators opinion would preclude the subject from participating

Study chairs or principal investigators

Willard Dere, M.D.,  Study Chair,  Amgen   

Study ID Numbers:  20020125
Last Updated:  August 1, 2005
Record first received:  July 20, 2005
ClinicalTrials.gov Identifier:  NCT00121043
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-02