Ancillary Study to Protocol 20060104

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439894
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : March 21, 2008
Information provided by:

Brief Summary:
Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Procedure: Blood draw

Study Type : Observational
Actual Enrollment : 50 participants
Official Title: Protein Phosphorylation Ancillary Study to Amgen Protocol 20060104: Open Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis
Study Start Date : December 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Group/Cohort Intervention/treatment
blood draw
One time blood draw
Procedure: Blood draw
blood draw at baseline, week 12 and week 24

Primary Outcome Measures :
  1. To explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity. [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. Explore the correlations to etanercept clinical response (ACR and DAS scores) may also be explored. [ Time Frame: week 24 ]

Biospecimen Retention:   None Retained
no biospecimens will be retained.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who enrolled in to Etanercept SFP 20060104 study and signed the 20060364 informed consent.

Inclusion Criteria:

  • Signed informed Consent Meet all inclusion critieria outlined in Amgen Protocol 20060104

Exclusion Criteria:

  • Meet exclusion criteria outlined in Amgen Protocol 20060104

Information from the National Library of Medicine

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 identifier (NCT number): NCT00439894

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00439894     History of Changes
Other Study ID Numbers: 20060364
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: March 21, 2008
Last Verified: March 2008

Keywords provided by Amgen:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors