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

Information source: Swedish Orphan Biovitrum
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Summary

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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Eligibility

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website


Last updated: November 25, 2009

Page last updated: August 23, 2015

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