Rheumatoid ArthritisNCT02794012
Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Periodontal Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the association of Rheumatoid Arthritis (RA)-related antibodies and periodontal inflammation in subjects at-risk for Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Periodontal Disease
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2017
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include: subjects at-risk for RA, subjects with early RA, and healthy controls >40 years old.
Who may be able to join
- Rheumatoid Arthritis-antibody positivity (anti-CCP) in the absence of arthritis or
- Early RA <36 months since diagnosis
Who cannot join
- Pregnancy
- Antibiotic use prior to dental procedures or cleanings
- Wear dentures
- <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the association of Rheumatoid Arthritis (RA)-related antibodies and periodontal inflammation in subjects at-risk for Rheumatoid Arthritis. Subjects will undergo periodontal and joint examinations, as well as collection of body fluids to measure Rheumatoid Arthritis-related antibodies.
- Conditions
- Rheumatoid Arthritis, Periodontal Disease
- Medical subject headings
- Arthritis, Rheumatoid, Periodontal 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 |
|---|---|---|
| At-Risk Rheumatoid Arthritis subjects | Not described | |
| Early Rheumatoid Arthritis subjects | Not described | |
| Healthy Controls | Not described | |
| Non-Rheumatoid Arthritis Autoimmune Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines
Measured: 1 day
Secondary outcomes (2)
Frequency of bacterial communities of the periodontium by bacterial diversity (e.g. Shannon Diversity Index) and bacterial load (qPCR)
Measured: 1 day
Frequency of Rheumatoid Arthritis-related antibodies in blood and mucosal sites using Rheumatoid Factor and Anti-Citrullinated Protein Antibody assays
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2017
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 Colorado, DenverThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Responsible party
- Sponsor
- Investigators
- Lindsay B Kelmenson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794012
- Sponsor's protocol ID
- 15-2288
- Status last verified
- Jan 2018
- First submitted
- 26 May 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02794012
- Acronym / sponsor ID
- 15-2288
- Conditions
- Rheumatoid Arthritis, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Jun 2016 (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 purpose of this study is to evaluate the association of Rheumatoid Arthritis (RA)-related antibodies and periodontal inflammation in subjects at-risk for Rheumatoid Arthritis. Subjects will undergo periodontal and joint examinations, as well as collection of body fluids to measure Rheumatoid Arthritis-related antibodies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| At-Risk Rheumatoid Arthritis subjects | – | – |
| Early Rheumatoid Arthritis subjects | – | – |
| Healthy Controls | – | – |
| Non-Rheumatoid Arthritis Autoimmune Controls | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include: subjects at-risk for RA, subjects with early RA, and healthy controls >40 years old.
Key inclusion criteria (2 listed)
- Rheumatoid Arthritis-antibody positivity (anti-CCP) in the absence of arthritis or
- Early RA <36 months since diagnosis
Key exclusion criteria (4 listed)
- Pregnancy
- Antibiotic use prior to dental procedures or cleanings
- Wear dentures
- <18 years old
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
Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines
Time frame: 1 day
2 secondary outcomes
Frequency of bacterial communities of the periodontium by bacterial diversity (e.g. Shannon Diversity Index) and bacterial load (qPCR)
Time frame: 1 day
Frequency of Rheumatoid Arthritis-related antibodies in blood and mucosal sites using Rheumatoid Factor and Anti-Citrullinated Protein Antibody assays
Time frame: 1 day
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 9 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Lindsay B Kelmenson, MD principal investigator
University of Colorado, Denver
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 and Periodontal Disease, run by University of Colorado, Denver 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 2 inclusion and 4 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 9 Jan 2018. 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?
Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines (time frame: 1 day). 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 9 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.