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Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of Colorado, Denver
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00594451
First received: January 3, 2008
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  Purpose

The objective of the proposed study is to assess the role of smoking and complex gene-smoking interactions in two understudied Rheumatoid Arthritis (RA)groups.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gene-Environment Interactions in RA Autoimmunity Disease Severity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Rheumatoid factor (RF) antibody status and concentration [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Anti-CCP antibody status and concentration [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Evidence of radiographic erosions and scoring. [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking status and cotinine levels obtained on subjects. [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Genotyping of the FSTM1, NAT1, NAT2, and mDEH genes [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Both racial/ethnic composition and disease characteristics [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

All subjects will provide baseline serum and DNA.


Estimated Enrollment: 800
Study Start Date: October 2006
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
I
multicenter Veteran Affairs Rheumatoid Arthritis (VARA) registry
II
NIH-funded Consortium for the Longitudinal Evaluation of African Americans with Early RA (CLEAR)

Detailed Description:

Rheumatoid Arthritis (RA) is a systemic inflammatory disease affecting over 2 million people in the U.S. alone, a condition characterized by progressive joint destruction, significant work-related disability and accelerated mortality. While the precise cause of RA is unknown, it is clear that the disease does not result from a single heritable factor or single environmental exposure. Of the many environmental exposures that have been studied, cigarette smoking is the factor most consistently shown to be associated with RA onset. In addition to its role in disease susceptibility, recent studies have found that smoking, along with genetic factors, contribute to RA-related autoimmunity and disease severity. Moreover, studies to date looking at disease severity in RA have exclusively involved women of Caucasian/European ancestry. This is an important distinction since although RA is more common in women, smoking appears to be most closely linked to RA risk in men. Additionally, the burden of other smoking-related illnesses appears to be greatest among non-Caucasian populations. For this reason and because smoking rates and prevalence of risk-alleles differ in ethnic/racial minorities (i.e. SE and GSTM1-null polymorphism), further studies are needed to define the association of smoking and possible gene-smoking interactions and their role in autoimmunity and disease severity in these understudied populations.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Omaha VA patients

Criteria

Inclusion Criteria:

  • Meeting ACR criteria for RA

Exclusion Criteria:

  • No exclusions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594451

Contacts
Contact: Ted R Mikuls, MD, MSPH 402-559-7258 tmikuls@unmc.edu

Locations
United States, Nebraska
Omaha Veteran Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: Ted R Mikuls, MD, MSPH     402-559-7258     tmikuls@unmc.edu    
Principal Investigator: Ted R Mikuls, MD, MSPH            
Sponsors and Collaborators
University of Nebraska
University of Alabama at Birmingham
University of Colorado, Denver
Investigators
Principal Investigator: Ted R Mikuls, MD, MSPH University of Nebraska
  More Information

Additional Information:
National Institute of Health  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ted Mikuls, MD, MSPH, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00594451     History of Changes
Other Study ID Numbers: 358-06-NH, 1 R03 AR054539-01
Study First Received: January 3, 2008
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
rheumatoid arthritis
cigarette smoking
gene-environmental interactions
autoimmunity
disease severity

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 May 23, 2013