Rheumatoid ArthritisNCT00594451
Gene-Environment Interactions in Rheumatoid Arthritis Autoimmunity Disease Severity
An observational study of Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2006to 1 Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Omaha VA patients
Who may be able to join
- Meeting ACR criteria for RA
Who cannot join
- No exclusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Omaha Veteran's Affairs Medical Center
Omaha, Nebraska, 68105
About this study
Official title: Gene-Environment Interactions in RA Autoimmunity Disease Severity
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.
Read the 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
- Keywords
- rheumatoid arthritis, cigarette smoking, gene-environmental interactions, autoimmunity, disease severity
- Medical subject headings
- Arthritis, Rheumatoid, Cigarette Smoking, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline
Secondary outcomes (3)
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.
Measured: baseline
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.
Measured: baseline
Racial/ethnic composition and disease characteristics
Both racial/ethnic composition and disease characteristics are recorded for analysis.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study start19 Oct 2006
- Primary completion1 Apr 2010
- Study completion1 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of Colorado, Denver, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Ted R Mikuls, MD, MSPH, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594451
- Sponsor's protocol ID
- 0358-06-NH
- Other IDs
- 1R03AR054539-01
- Status last verified
- Aug 2023
- First submitted
- 3 Jan 2008
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene-Environment Interactions in RA Autoimmunity Disease Severity
- ClinicalTrials.gov ID
- NCT00594451
- Acronym / sponsor ID
- 0358-06-NH
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, cigarette smoking, gene-environmental interactions, autoimmunity, disease severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of Colorado, Denver, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 19 Oct 2006 (actual)
- Primary completion
- 1 Apr 2010 (actual)
- Study completion
- 1 Jan 2013 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Omaha VA patients
Key inclusion criteria (1 listed)
- Meeting ACR criteria for RA
Key exclusion criteria (1 listed)
- No exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rheumatoid factor (RF) antibody status and concentration
Time frame: baseline
Rheumatoid factor (RF) antibody status and concentration. RF is an autoantibody that responds to inflammation caused by RA.
Anti-CCP antibody status and concentration
Time frame: baseline
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.
Evidence of radiographic erosions and scoring.
Time frame: baseline
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.
3 secondary outcomes
Smoking status and cotinine levels
Time frame: baseline
Genotyping of the FSTM1, NAT1, NAT2, and mDEH genes
Time frame: baseline
Racial/ethnic composition and disease characteristics
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- National Institute of HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted R Mikuls, MD, MSPH principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rheumatoid factor (RF) antibody status and concentration (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.