Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121043
Status:
COMPLETED
Last Update Posted:
2009-11-26
First Post:
2005-06-30
Brief Title:
Evaluating Kineret Anakinra in Rheumatoid Arthritis RA Subjects Using aSelf-Reported Questionnaire
Sponsor:
Amgen
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
An Open Label Randomized Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringes Using Kineret Anakinra in Rheumatoid Arthritis RA Subjects Using A Self-Reported Questionnaire
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to assess the ease-of-use of SimpleJectTM compared to pre-filled syringes 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None