NCT00117091

Brief Summary

The purpose of this study is to evaluate the percentage of subjects in Australian clinical practice continuing treatment with Anakinra (Kineret®) at the end of study week 48 in subjects with active RA. The continued use of Kineret® will be based on pre-defined response assessment criteria for subjects with active RA.

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
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2005

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

June 30, 2005

Last Update Submit

December 20, 2007

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisRAAnakinra (Kineret®)

Outcome Measures

Primary Outcomes (1)

  • % of subjects continuing Kineret® therapy at the end of the study (I.e., responders according to pre-defined response assessment criteria.)

Secondary Outcomes (4)

  • Change in Health Related Quality of Life (HRQOL) scores at the end of study weeks 12, 24, 36 and 48.

  • feasibility of simpleject device

  • treatment response (ACR scores, DAS 28) at the end of study weeks 12, 24, 36 and 48.

  • Safety of Kineret® when added to current DMARD therapy.

Interventions

Anakinra (Kineret®)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, Rheumatoid

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 4, 2005

Last Updated

December 24, 2007

Record last verified: 2007-12