Expired Study
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Omaha, Nebraska 68105


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 summary:

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.


Inclusion Criteria: - Meeting ACR criteria for RA Exclusion Criteria: - No exclusions

Study is Available At:

Original ID:




Secondary ID:

1 R03 AR054539-01

Study Acronym:

Brief Title:

Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity

Official Title:

Gene-Environment Interactions in RA Autoimmunity Disease Severity

Overall Status:


Study Phase:




Minimum Age:

19 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Nebraska

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Cohort, Time Perspective: C

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Ted R Mikuls, MD, MSPH
Principal Investigator
University of Nebraska

Study Dates

Start Date:October 2006
Completion Date:January 2013
Completion Type:Actual
Primary Completion Date:April 2010
Primary Completion Type:Actual
Verification Date:January 2010
Last Changed Date:June 18, 2013
First Received Date:January 3, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Rheumatoid factor (RF) antibody status and concentration
Time Frame:baseline
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Anti-CCP antibody status and concentration
Time Frame:baseline
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Evidence of radiographic erosions and scoring.
Time Frame:baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Smoking status and cotinine levels obtained on subjects.
Time Frame:baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Genotyping of the FSTM1, NAT1, NAT2, and mDEH genes
Time Frame:baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Both racial/ethnic composition and disease characteristics
Time Frame:baseline
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:I
Description:multicenter Veteran Affairs Rheumatoid Arthritis (VARA) registry
Study Arm Type:Other
Arm Name:II
Description:NIH-funded Consortium for the Longitudinal Evaluation of African Americans with Early RA (CLEAR)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Nebraska
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Alabama at Birmingham

Samples and Retentions

Sample Retention:Samples With DNA
Description: All subjects will provide baseline serum and DNA.
Study Population: Omaha VA patients
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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