Ancillary Study to Protocol 20060104 - Full Text View

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

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

Etanercept BaseLine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, Other

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

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

Biospecimen Description:

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

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439894

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060364
First Received:	February 22, 2007
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00439894
Health Authority:	United States: Institutional Review Board