Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity

NCT00594451 | Completed DMC

• 2 other identifiers: 0358-06-NH1R03AR054539-01
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; cigarette smoking; gene-environmental interactions; autoimmunity; disease severity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Smoking status and cotinine levels

  baseline

• Genotyping of the FSTM1, NAT1, NAT2, and mDEH genes

  baseline

• Racial/ethnic composition and disease characteristics

  baseline

Study Arms (2)

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

multicenter Veteran Affairs Rheumatoid Arthritis (VARA) registry

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)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Omaha VA patients

You may qualify if:

• Meeting ACR criteria for RA

Sponsors & Collaborators

• University of Nebraska: lead
• University of Alabama at Birmingham: collaborator
• University of Colorado, Denver: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Omaha Veteran's Affairs Medical Center

Omaha, Nebraska, 68105, United States

Location

Related Links

• National Institute of Health

Biospecimen

Retention: SAMPLES WITH DNA

All subjects will provide baseline serum and DNA.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Cigarette Smoking; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Ted R Mikuls, MD, MSPH

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: October 19, 2006
• Primary Completion: April 1, 2010
• Study Completion: January 1, 2013
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

US (1)