Clinical trial NCT00594451: Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity
Official title: Gene-Environment Interactions in RA Autoimmunity Disease Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
cigarette smoking
gene-environmental interactions
autoimmunity
disease severity
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: University of Colorado, Denver
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2008-01-15
Enrollment: 800
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Omaha VA patients

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.

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 criteria: Inclusion Criteria:

* Meeting ACR criteria for RA

Exclusion Criteria:

* No exclusions

Primary outcomes:
measure: Rheumatoid factor (RF) antibody status and concentration
timeFrame: baseline
measure: Anti-CCP antibody status and concentration
timeFrame: baseline
measure: Evidence of radiographic erosions and scoring.
timeFrame: baseline
Secondary outcomes:
measure: Smoking status and cotinine levels
timeFrame: baseline
measure: Genotyping of the FSTM1, NAT1, NAT2, and mDEH genes
timeFrame: baseline
measure: Racial/ethnic composition and disease characteristics
timeFrame: baseline
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Omaha Veteran's Affairs Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Ted R Mikuls, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: