Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire

Condition(s) targeted: Rheumatoid Arthritis

Intervention: SimpleJectTM (Device); Kineret® (Anakinra) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

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

Study design: Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Difference in the EAQ Part B Ease of Use Subscale Score between the two injection methods

Secondary outcome:

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

AmgenTrials clinical trials website

Last updated: December 20, 2007