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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
History of Changes
  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:

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

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

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

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

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
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013