Ancillary Study to Protocol 20060104

This study has been completed.
Information provided by:
Amgen Identifier:
First received: February 22, 2007
Last updated: March 20, 2008
Last verified: March 2008
Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment.

Condition Intervention
Rheumatoid Arthritis
Procedure: Blood draw

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • To explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity. [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Explore the correlations to etanercept clinical response (ACR and DAS scores) may also be explored. [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained
no biospecimens will be retained.

Enrollment: 50
Study Start Date: December 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
blood draw
One time blood draw
Procedure: Blood draw
blood draw at baseline, week 12 and week 24


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00439894

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00439894     History of Changes
Other Study ID Numbers: 20060364 
Study First Received: February 22, 2007
Last Updated: March 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 26, 2016