Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity

Rheumatoid Arthritis Clinical Trial

Official title:

Gene-Environment Interactions in RA Autoimmunity Disease Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594451
• Other study ID #: 0358-06-NH
• Secondary ID: 1R03AR054539-01
• Status: Completed
• Start date: October 19, 2006
• Est. completion date: January 1, 2013

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 1, 2013
• Est. primary completion date: April 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Meeting ACR criteria for RA

Exclusion Criteria:

• No exclusions

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Omaha Veteran's Affairs Medical Center	Omaha	Nebraska

Sponsors (4)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Alabama at Birmingham, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rheumatoid factor (RF) antibody status and concentration	Rheumatoid factor (RF) antibody status and concentration. RF is an autoantibody that responds to inflammation caused by RA.	baseline
Primary	Anti-CCP antibody status and concentration	Anti-CCP (cyclic citrullinated peptide antibodies) antibody status and concentration.; The normal level of anti-CCP antibodies is less than 20 units/mL. Anything over this level means a positive test. Anti-cyclic citrullinated peptide antibody titer predicts time to rheumatoid arthritis onset in patients with undifferentiated arthritis.	baseline
Primary	Evidence of radiographic erosions and scoring.	Evidence of radiographic erosions and scoring. Erosions are graded from 0 to 4 (0 = normal; 1 = questionable; 2 = definite but mild; 3 = moderate; and 4 = severe). This method requires a standard reference set of radiographs for comparison. The range of erosion scores is from 0 to 128 in the hands, and from 0 to 48 in the feet.	baseline
Secondary	Smoking status and cotinine levels	Smoking status and cotinine levels are recorded. Cotinine is measured in nanograms per milliliter (ng/mL): Cotinine levels in a nonsmoker are generally less than 10 ng/mL. Cotinine levels in a light smoker or someone exposed to secondhand smoke are 11 ng/mL to 30 ng/mL. Cotinine levels in a heavy smoker may be more than 500 ng/mL.	baseline
Secondary	Genotyping of the FSTM1, NAT1, NAT2, and mDEH genes	Samples will be taken to genotype FSTM1, NAT1, NAT2, and mDEH genes which are important in carcinogenesis.	baseline
Secondary	Racial/ethnic composition and disease characteristics	Both racial/ethnic composition and disease characteristics are recorded for analysis.	baseline

External Links

•   National Institute of Health