Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity

NCT ID: NCT00594451

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-19
• Study Completion Date: 2013-01-01

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

I Multicenter Veteran's Affairs Rheumatoid Arthritis (VARA) registry

multicenter Veteran Affairs Rheumatoid Arthritis (VARA) registry

No interventions assigned to this group

II NIH-funded Consortium for the Longitudinal Evaluation of African Americans with Early RA (CLEAR)

NIH-funded Consortium for the Longitudinal Evaluation of African Americans with Early RA (CLEAR)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Meeting ACR criteria for RA

Exclusion Criteria

• No exclusions

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ted R Mikuls, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Omaha Veteran's Affairs Medical Center

Omaha, Nebraska, United States

Countries

United States

Related Links

http://grants1.nih.gov/grants/oer.htm

National Institute of Health

Other Identifiers

1R03AR054539-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0358-06-NH

Identifier Type: -

Identifier Source: org_study_id