Back to resultsAncillary Study to Protocol 20060104
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Blood draw
Sponsored by
About this trial
This is an observational trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, etanercept, Enbrel, Amgen
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Arm Label
blood draw
Arm Description
One time blood draw
Outcomes
Primary Outcome Measures
To explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity.
Secondary Outcome Measures
Explore the correlations to etanercept clinical response (ACR and DAS scores) may also be explored.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00439894
Brief Title
Ancillary Study to Protocol 20060104
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 Type
Observational
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, etanercept, Enbrel, Amgen
7. Study Design
Enrollment
50 (Actual)
Biospecimen Retention
None Retained
Biospecimen Description
no biospecimens will be retained.
8. Arms, Groups, and Interventions
Arm Title
blood draw
Arm Description
One time blood draw
Intervention Type
Procedure
Intervention Name(s)
Blood draw
Intervention Description
blood draw at baseline, week 12 and week 24
Primary Outcome Measure Information:
Title
To explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity.
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Explore the correlations to etanercept clinical response (ACR and DAS scores) may also be explored.
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
Subjects who enrolled in to Etanercept SFP 20060104 study and signed the 20060364 informed consent.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Ancillary Study to Protocol 20060104
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