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Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity

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ClinicalTrials.gov Identifier: NCT00594451
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : June 19, 2013
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of Colorado, Denver
Information provided by (Responsible Party):
Ted Mikuls, MD MSPH, University of Nebraska

Brief Summary:
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 or disease
Rheumatoid Arthritis

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.

Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gene-Environment Interactions in RA Autoimmunity Disease Severity
Study Start Date : October 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : January 2013


Group/Cohort
I
multicenter Veteran Affairs Rheumatoid Arthritis (VARA) registry
II
NIH-funded Consortium for the Longitudinal Evaluation of African Americans with Early RA (CLEAR)



Primary Outcome Measures :
  1. Rheumatoid factor (RF) antibody status and concentration [ Time Frame: baseline ]
  2. Anti-CCP antibody status and concentration [ Time Frame: baseline ]
  3. Evidence of radiographic erosions and scoring. [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Smoking status and cotinine levels obtained on subjects. [ Time Frame: baseline ]
  2. Genotyping of the FSTM1, NAT1, NAT2, and mDEH genes [ Time Frame: baseline ]
  3. Both racial/ethnic composition and disease characteristics [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
All subjects will provide baseline serum and DNA.


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594451


Locations
United States, Nebraska
Omaha Veteran Medical Center
Omaha, Nebraska, United States, 68105
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

Additional Information:
Responsible Party: Ted Mikuls, MD MSPH, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00594451     History of Changes
Other Study ID Numbers: 358-06-NH
1R03AR054539-01 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: January 2010

Keywords provided by Ted Mikuls, MD MSPH, University of Nebraska:
rheumatoid arthritis
cigarette smoking
gene-environmental interactions
autoimmunity
disease severity

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