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

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ClinicalTrials.gov Identifier: NCT00121043
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : November 26, 2009
Sponsor:
Information provided by:
Swedish Orphan Biovitrum

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: SimpleJectTM Drug: Kineret® (Anakinra) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Difference in the EAQ Part B Ease of Use Subscale Score between the two injection methods

Secondary Outcome Measures :
  1. Difference between the two injection methods for the following
  2. EAQ Part B Total Score.
  3. EAQ Part B Overall Satisfaction Subscale Score.
  4. EAQ Part B Anxiety/Fear of Needles Subscale Score.
  5. EAQ Part B Confidence in Ability of Use Subscale Score.
  6. EAQ Part B Pain/Discomfort Subscale Score.
  7. EAQ Part C Total Preference Score.
  8. EAQ Quality Measures.
  9. EAQ Item Performance Measures.
  10. EAQ Instrument Reliability Measures.
  11. Incidence and severity of AE's.
  12. Incidence of concomitant medications.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121043


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information
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Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00121043     History of Changes
Other Study ID Numbers: 20020125
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: December 2007

Keywords provided by Swedish Orphan Biovitrum:
Rheumatoid Arthritis, Inflammation
Interleukin-1 (IL-1), r-metHuIL-1ra
Autoimmune, Kineret®
Anakinra, Immunex
Amgen, Clinical Trials

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents