NCT02794012

Brief 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. Subjects will undergo periodontal and joint examinations, as well as collection of body fluids to measure Rheumatoid Arthritis-related antibodies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

May 26, 2016

Last Update Submit

January 5, 2018

Conditions

Rheumatoid ArthritisPeriodontal Disease

Outcome Measures

Primary Outcomes (1)

  • Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines

    1 day

Secondary Outcomes (2)

  • Frequency of bacterial communities of the periodontium by bacterial diversity (e.g. Shannon Diversity Index) and bacterial load (qPCR)

    1 day

  • Frequency of Rheumatoid Arthritis-related antibodies in blood and mucosal sites using Rheumatoid Factor and Anti-Citrullinated Protein Antibody assays

    1 day

Study Arms (4)

At-Risk Rheumatoid Arthritis subjects

Early Rheumatoid Arthritis subjects

Healthy Controls

Non-Rheumatoid Arthritis Autoimmune Controls

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include: subjects at-risk for RA, subjects with early RA, and healthy controls \>40 years old.

You may qualify if:

  • Rheumatoid Arthritis-antibody positivity (anti-CCP) in the absence of arthritis or
  • Early RA \<36 months since diagnosis

You may not qualify if:

  • Pregnancy
  • Antibiotic use prior to dental procedures or cleanings
  • Wear dentures
  • \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidPeriodontal Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Lindsay B Kelmenson, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 8, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)