Rheumatoid Arthritis Patients and Porphyromonas Gingivalis

July 25, 2019 updated by: Centre Hospitalier Universitaire de Saint Etienne

Porphyromonas Gingivalis Contribution in Rheumatoid Arthritis (RA).

Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint destruction strongly correlated with anti-citrullinated protein antibodies citrullinated anti-peptide (ACPA). Precise RA etiology remained unclear with a described association between RA and periodontal disease. The missing link could be a gram-negative anaerobic bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in periodontal disease and able to induce gingival citrullinated protein via an enzyme called peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in RA, the investigators will compare its effect on various cell type with comparison with another oral bacteria Provatella intermedia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • CHU Saint-etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Rheumatoid arthritis and osteoarthritis

Description

Inclusion Criteria:

  • Age >18 ans
  • RA or osteoarthritis with joint surgery planned
  • Informed consent approved and signed

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid arthritis
blood sample specimen and synoviocytes from synovial tissue
Procedure: blood sample
Procedure: synovial tissue
synoviocytes from synovial tissue
Osteoarthritis
blood sample specimen and synoviocytes from synovial tissue
Procedure: blood sample
Procedure: synovial tissue
synoviocytes from synovial tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of genetic signature after induction by P. gingivalis and P. intermedia on synoviocytes
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of specific transcriptome profile induced by P. gingivalis compared to P. intermedia on peripheral blood mononuclear cells (PBMC) and gingival fibroblasts
Time Frame: day 1
day 1
Comparison of transcriptome profile between P. gingivalis and P. intermedia on RA synovial cells.
Time Frame: day 1
day 1
Comparison of the transcriptomic profile between RA and osteoarthritis synoviocytes
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Hubert MAROTTE, PhD, CHU Saint-etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2016

Primary Completion (Actual)

June 27, 2016

Study Completion (Actual)

June 27, 2016

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408022
  • 2014-A01688-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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