Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Gene-Environment Interactions in RA Autoimmunity Disease Severity|
- 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 ]
- 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.
|Study Start Date:||October 2006|
|Study Completion Date:||January 2013|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
multicenter Veteran Affairs Rheumatoid Arthritis (VARA) registry
NIH-funded Consortium for the Longitudinal Evaluation of African Americans with Early RA (CLEAR)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594451
|United States, Nebraska|
|Omaha Veteran Medical Center|
|Omaha, Nebraska, United States, 68105|
|Principal Investigator:||Ted R Mikuls, MD, MSPH||University of Nebraska|