Rheumatoid ArthritisNCT02905175
Rheumatoid Arthritis Patients and Porphyromonas Gingivalis
An observational study of Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- blood sample and synovial tissue
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2016to 27 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid arthritis and osteoarthritis
Who may be able to join
- Age >18 ans
- RA or osteoarthritis with joint surgery planned
- Informed consent approved and signed
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- blood sample, synovial tissue
- Keywords
- rheumatoid arthritis, Porphyromonas gingivalis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
synovial tissueProcedure or surgery
synoviocytes from synovial tissue
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | blood sample specimen and synoviocytes from synovial tissue Receives: Procedure: blood sample; Procedure: synovial tissue | |
| Osteoarthritis | blood sample specimen and synoviocytes from synovial tissue Receives: Procedure: blood sample; Procedure: synovial tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of genetic signature after induction by P. gingivalis and P. intermedia on synoviocytes
Measured: 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
Measured: day 1
Comparison of transcriptome profile between P. gingivalis and P. intermedia on RA synovial cells.
Measured: day 1
Comparison of the transcriptomic profile between RA and osteoarthritis synoviocytes
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start13 Jan 2016
- Primary completion27 Jun 2016
- Study completion27 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert Marotte, phD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905175
- Sponsor's protocol ID
- 1408022
- Other IDs
- 2014-A01688-39
- Status last verified
- Oct 2018
- First submitted
- 14 Sep 2016
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porphyromonas Gingivalis Contribution in Rheumatoid Arthritis (RA).
- ClinicalTrials.gov ID
- NCT02905175
- Acronym / sponsor ID
- 1408022
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, Porphyromonas gingivalis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 27 Jun 2016 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | – | Procedure: blood sample, Procedure: synovial tissueblood sample specimen and synoviocytes from synovial tissue |
| Osteoarthritis | – | Procedure: blood sample, Procedure: synovial tissueblood sample specimen and synoviocytes from synovial tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis and osteoarthritis
Key inclusion criteria (3 listed)
- Age >18 ans
- RA or osteoarthritis with joint surgery planned
- Informed consent approved and signed
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample | Procedure or surgery | Osteoarthritis, Rheumatoid arthritis |
| synovial tissuesynoviocytes from synovial tissue | Procedure or surgery | Osteoarthritis, Rheumatoid arthritis |
Primary outcome
Comparison of genetic signature after induction by P. gingivalis and P. intermedia on synoviocytes
Time frame: day 1
3 secondary outcomes
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
Comparison of transcriptome profile between P. gingivalis and P. intermedia on RA synovial cells.
Time frame: day 1
Comparison of the transcriptomic profile between RA and osteoarthritis synoviocytes
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Marotte, phD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of genetic signature after induction by P. gingivalis and P. intermedia on synoviocytes (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.