Ancillary Study to Protocol 20060104

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00439894
First received: February 22, 2007
Last updated: March 20, 2008
Last verified: March 2008
  Purpose

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

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT00439894

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov 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
etanercept
Enbrel
Amgen

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014