NCT02905175

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
Last Updated

July 26, 2019

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

September 14, 2016

Last Update Submit

July 25, 2019

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisPorphyromonas gingivalis

Outcome Measures

Primary Outcomes (1)

  • Comparison of genetic signature after induction by P. gingivalis and P. intermedia on synoviocytes

    day 1

Secondary Outcomes (3)

  • Comparison of specific transcriptome profile induced by P. gingivalis compared to P. intermedia on peripheral blood mononuclear cells (PBMC) and gingival fibroblasts

    day 1

  • Comparison of transcriptome profile between P. gingivalis and P. intermedia on RA synovial cells.

    day 1

  • Comparison of the transcriptomic profile between RA and osteoarthritis synoviocytes

    day 1

Study Arms (2)

Rheumatoid arthritis

blood sample specimen and synoviocytes from synovial tissue

Procedure: blood sampleProcedure: synovial tissue

Osteoarthritis

blood sample specimen and synoviocytes from synovial tissue

Procedure: blood sampleProcedure: synovial tissue

Interventions

blood samplePROCEDURE
OsteoarthritisRheumatoid arthritis
synovial tissuePROCEDURE

synoviocytes from synovial tissue

OsteoarthritisRheumatoid arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Rheumatoid arthritis and osteoarthritis

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample and synovial tissue

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Hubert Marotte, phD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 19, 2016

Study Start

January 13, 2016

Primary Completion

June 27, 2016

Study Completion

June 27, 2016

Last Updated

July 26, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)