Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT02794012 |
Recruitment Status :
Completed
First Posted : June 8, 2016
Last Update Posted : January 9, 2018
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Sponsor:
University of Colorado, Denver
Collaborator:
Rheumatology Research Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
Tracking Information | ||||
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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 |
Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines [ Time Frame: 1 day ] | |||
Original Primary Outcome Measures |
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 |
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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 |
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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 |
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Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
146 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Responsible Party | University of Colorado, Denver | |||
Study Sponsor | University of Colorado, Denver | |||
Collaborators | Rheumatology Research Foundation | |||
Investigators |
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PRS Account | University of Colorado, Denver | |||
Verification Date | January 2018 |