search
Back to results

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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
SimpleJectTM
Kineret® (Anakinra)
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Inflammation, Interleukin-1 (IL-1), r-metHuIL-1ra, Autoimmune, Kineret®, Anakinra, Immunex, Amgen, Clinical Trials

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 30, 2005
    Last Updated
    November 25, 2009
    Sponsor
    Amgen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00121043
    Brief Title
    Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Rheumatoid Arthritis, Inflammation, Interleukin-1 (IL-1), r-metHuIL-1ra, Autoimmune, Kineret®, Anakinra, Immunex, Amgen, Clinical Trials

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    SimpleJectTM
    Intervention Type
    Drug
    Intervention Name(s)
    Kineret® (Anakinra)
    Primary Outcome Measure Information:
    Title
    Difference in the EAQ Part B Ease of Use Subscale Score between the two injection methods
    Secondary Outcome Measure Information:
    Title
    Difference between the two injection methods for the following
    Title
    EAQ Part B Total Score.
    Title
    EAQ Part B Overall Satisfaction Subscale Score.
    Title
    EAQ Part B Anxiety/Fear of Needles Subscale Score.
    Title
    EAQ Part B Confidence in Ability of Use Subscale Score.
    Title
    EAQ Part B Pain/Discomfort Subscale Score.
    Title
    EAQ Part C Total Preference Score.
    Title
    EAQ Quality Measures.
    Title
    EAQ Item Performance Measures.
    Title
    EAQ Instrument Reliability Measures.
    Title
    Incidence and severity of AE's.
    Title
    Incidence of concomitant medications.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs