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Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794012
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Rheumatology Research Foundation
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date May 26, 2016
First Posted Date June 8, 2016
Last Update Posted Date January 9, 2018
Actual Study Start Date July 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2016)		 Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines [ Time Frame: 1 day ]
Original Primary Outcome Measures
 (submitted: June 2, 2016)		 Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) 1999 guidelines [ Time Frame: 1 day ]
Change History
Current Secondary Outcome Measures
 (submitted: June 2, 2016)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
Official Title Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will include: subjects at-risk for RA, subjects with early RA, and healthy controls >40 years old.
Condition
  • Rheumatoid Arthritis
  • Periodontal Disease
Intervention Not Provided
Study Groups/Cohorts
  • At-Risk Rheumatoid Arthritis subjects
  • Early Rheumatoid Arthritis subjects
  • Healthy Controls
  • Non-Rheumatoid Arthritis Autoimmune Controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 5, 2018)		 146
Original Estimated Enrollment
 (submitted: June 2, 2016)		 180
Actual Study Completion Date December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Antibiotic use prior to dental procedures or cleanings
  • Wear dentures
  • <18 years old
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02794012
Other Study ID Numbers 15-2288
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Rheumatology Research Foundation
Investigators
Principal Investigator: Lindsay B Kelmenson, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date January 2018