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Rheumatoid Arthritis Patients and Porphyromonas Gingivalis

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: NCT02905175
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Procedure: blood sample Procedure: synovial tissue

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Porphyromonas Gingivalis Contribution in Rheumatoid Arthritis (RA).
Actual Study Start Date : January 13, 2016
Actual Primary Completion Date : June 27, 2016
Actual Study Completion Date : June 27, 2016

Resource links provided by the National Library of Medicine


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




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

Secondary Outcome Measures :
  1. 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 ]
  2. Comparison of transcriptome profile between P. gingivalis and P. intermedia on RA synovial cells. [ Time Frame: day 1 ]
  3. Comparison of the transcriptomic profile between RA and osteoarthritis synoviocytes [ Time Frame: day 1 ]

Biospecimen Retention:   Samples Without DNA
blood sample and synovial tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Rheumatoid arthritis and osteoarthritis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905175


Locations
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France
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Hubert Marotte, phD CHU Saint-Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02905175    
Other Study ID Numbers: 1408022
2014-A01688-39 ( Other Identifier: ANSM )
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
rheumatoid arthritis
Porphyromonas gingivalis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases