NCT00121043

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

November 26, 2009

Status Verified

December 1, 2007

First QC Date

June 30, 2005

Last Update Submit

November 25, 2009

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, InflammationInterleukin-1 (IL-1), r-metHuIL-1raAutoimmune, Kineret®Anakinra, ImmunexAmgen, Clinical Trials

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

  • 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.

  • +7 more secondary outcomes

Interventions

SimpleJectTMDEVICE
Kineret® (Anakinra)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidInflammation

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 21, 2005

Last Updated

November 26, 2009

Record last verified: 2007-12