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Study Complete
Sponsor ID
20020125

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

Sponsor ID
20020125
Clinicaltrials.gov ID
NCT00121043
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
anakinra
Type
Interventional
Masking
None (Open Label)
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
N/A
Condition
  • Rheumatoid Arthritis
    • Sex
    N/A
    Trial Dates
    Nov 2002 - N/A
    Inclusion and Exclusion 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