Rheumatoid ArthritisMICROPORENCT04056234
Study of the Articular Microbiota in Rheumatoid Arthritis.
An observational study of Rheumatoid Arthritis and Synovial Disorder, run by University Hospital, Bordeaux.
Trial summary
The cause of rheumatoid arthritis (RA) remains unknown, although major advances have been done these last ten years in the comprehension of its pathophysiology. The aim of this study is to described a synovial microbiota specific for rheumatoid arthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis, Synovial Disorder, Arthrosis
- What is being tested?
- Joint puncture
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2012to 22 Feb 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a pilot study. The number of subjets will be 12 RA patients and 6 controls suffering from osteoarthritis.
Who may be able to join
- patients presenting with RA according to ACR87 and ACR/EULAR 2010 criteria
- patients presenting with RA anti-citrullinated peptide antibodies positive
- patients presenting with active RA, characterized by at least one synovitis
- patients presenting with an arthritis requiring arthrocentesis and synovial fluid collection for diagnostic or therapeutic purpose
- patients giving agreement to participate to the study and to sign informed consent.
Who cannot join
- patients suffering from osteoarthritis
- patients presenting with joint effusion justifying an arthrocentesis and synovial fluid collection for diagnostic of therapeutic purpose
- patients giving agreement to participate to the study and to sign informed consent
- Patients presenting with another arthropathy than anti-citrullinated peptide antibodies positive RA or osteoarthritis
- Patients not requiring arthrocentesis for medical reasons
- Patients refusing to sign informed consent
- Patients presenting with understanding problems due to language or cognitive reasons.
About this study
The cause of rheumatoid arthritis (RA) remains unknown, although major advances have been done these last ten years in the comprehension of its pathophysiology.
The aim of this study is to described a synovial microbiota specific for rheumatoid arthritis.
Read the detailed description
The cause of rheumatoid arthritis (RA) remains unknown, although major advances have been done these last ten years in the comprehension of its pathophysiology. One of the most significant discoveries was the post-translational modification of various self-proteins resulting in the replacement of arginine residues by citrulline. This conversion results in modifications of the basic charge of the peptides, of its primary and secondary structure, and the transformed peptides can then bound to some HLA-DR molecules (HLA-DR4, HLA-DR1), that are the best well known genetic factors of rheumatoid arthritis (RA). This leads to immunization to citrullinated peptides in genetically predisposed patients, which is now identified as the most characteristic auto-immun phenomenon of RA. Anti-citrullinated peptide antibodies (ACPA) have become the most relevant biologic test for the diagnosis of RA.
The conversion to citrulline is due to the action of an enzyme, the peptidyl arginine deiminase (PAD). Endogenous PADs have been identified in humans, but their activation needs high concentrations of calcium in the cells that are not physiological. Thus, the activation of self-PADs occurs only in extreme conditions, such as apoptosis, or major stresses resulting from toxic or infectious process. But some bacteria also contain PADs that are involved in their energetic metabolism. Two main factors have yet been identified to lead to citrullination of self-peptides and are now recognized as important environment risk factors for RA: smoking and periodontitis. Periodontitis is the consequence of an infection that is mainly due to Porphyromonas gingivalis, one of the bacteria processing a PAD. These facts reinforce the old hypothesis of an infectious origin of RA.
However, all RA patients are neither smoker nor affected by periodontitis, and many other bacteria have PADs and may be involved in the pathophysiology of RA. Moreover, it has been demonstrated that citrullination process and ACPA production can precede RA for years, while the citrullination and ACPA production are located to a mucous membrane (oral, pulmonary…). How these processes reach the joint remains a mystery.
The hypothesis is that the involved bacteria translocate to the joint, inducing local citrullination of synovial peptides, inflammation and production of ACPA within the joint, and resulting in arthritis.
The aim of this study is to demonstrate this translocation of bacteria in the synovium, and to described a synovial microbiota specific for rheumatoid arthritis .
Pilot study, including only few patients, just to demonstrate the validity of the translocation concept and the performance of the procedures.
- Conditions
- Rheumatoid Arthritis, Synovial Disorder, Arthrosis
- Being tested
- Joint puncture
- Keywords
- Translocation, Synovial microbiota
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint punctureProcedure or surgery
Patient requiring joint puncture for diagnostic or therapeutic reasons.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis group | Patients with rheumatoid arthritis Receives: Procedure: Joint puncture | |
| Control group | Patients with osteoarthritis / joint effusion. Receives: Procedure: Joint puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of bacterial DNA by 16s PCR
Detection by 16s PCR of DNA of bacterial origin in synovial fluid specimens
Measured: At the screening
Presence of a characteristic microbiota
Research of a characteristic microbiota of rheumatoid arthritis
Measured: At the screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start21 Feb 2012
- Primary completion22 Feb 2013
- Study completion22 Feb 2013
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 University Hospital, BordeauxThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie SHIPLEY, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056234
- Sponsor's protocol ID
- CHU BX 2011/12
- Acronym
- MICROPORE
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Articular Microbiota in Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT04056234
- Acronym / sponsor ID
- MICROPORE / CHU BX 2011/12
- Conditions
- Rheumatoid Arthritis, Synovial Disorder, Arthrosis
- Keywords
- Translocation, Synovial microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Feb 2012 (actual)
- Primary completion
- 22 Feb 2013 (actual)
- Study completion
- 22 Feb 2013 (actual)
- First posted
- 14 Aug 2019 (actual)
- 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.
The cause of rheumatoid arthritis (RA) remains unknown, although major advances have been done these last ten years in the comprehension of its pathophysiology.
The aim of this study is to described a synovial microbiota specific for rheumatoid arthritis.
Detailed description
The cause of rheumatoid arthritis (RA) remains unknown, although major advances have been done these last ten years in the comprehension of its pathophysiology. One of the most significant discoveries was the post-translational modification of various self-proteins resulting in the replacement of arginine residues by citrulline. This conversion results in modifications of the basic charge of the peptides, of its primary and secondary structure, and the transformed peptides can then bound to some HLA-DR molecules (HLA-DR4, HLA-DR1), that are the best well known genetic factors of rheumatoid arthritis (RA). This leads to immunization to citrullinated peptides in genetically predisposed patients, which is now identified as the most characteristic auto-immun phenomenon of RA. Anti-citrullinated peptide antibodies (ACPA) have become the most relevant biologic test for the diagnosis of RA.
The conversion to citrulline is due to the action of an enzyme, the peptidyl arginine deiminase (PAD). Endogenous PADs have been identified in humans, but their activation needs high concentrations of calcium in the cells that are not physiological. Thus, the activation of self-PADs occurs only in extreme conditions, such as apoptosis, or major stresses resulting from toxic or infectious process. But some bacteria also contain PADs that are involved in their energetic metabolism. Two main factors have yet been identified to lead to citrullination of self-peptides and are now recognized as important environment risk factors for RA: smoking and periodontitis. Periodontitis is the consequence of an infection that is mainly due to Porphyromonas gingivalis, one of the bacteria processing a PAD. These facts reinforce the old hypothesis of an infectious origin of RA.
However, all RA patients are neither smoker nor affected by periodontitis, and many other bacteria have PADs and may be involved in the pathophysiology of RA. Moreover, it has been demonstrated that citrullination process and ACPA production can precede RA for years, while the citrullination and ACPA production are located to a mucous membrane (oral, pulmonary…). How these processes reach the joint remains a mystery.
The hypothesis is that the involved bacteria translocate to the joint, inducing local citrullination of synovial peptides, inflammation and production of ACPA within the joint, and resulting in arthritis.
The aim of this study is to demonstrate this translocation of bacteria in the synovium, and to described a synovial microbiota specific for rheumatoid arthritis .
Pilot study, including only few patients, just to demonstrate the validity of the translocation concept and the performance of the procedures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis group | – | Procedure: Joint puncturePatients with rheumatoid arthritis |
| Control group | – | Procedure: Joint puncturePatients with osteoarthritis / joint effusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a pilot study. The number of subjets will be 12 RA patients and 6 controls suffering from osteoarthritis.
Key inclusion criteria (5 listed)
- patients presenting with RA according to ACR87 and ACR/EULAR 2010 criteria
- patients presenting with RA anti-citrullinated peptide antibodies positive
- patients presenting with active RA, characterized by at least one synovitis
- patients presenting with an arthritis requiring arthrocentesis and synovial fluid collection for diagnostic or therapeutic purpose
- patients giving agreement to participate to the study and to sign informed consent.
Key exclusion criteria (7 listed)
- patients suffering from osteoarthritis
- patients presenting with joint effusion justifying an arthrocentesis and synovial fluid collection for diagnostic of therapeutic purpose
- patients giving agreement to participate to the study and to sign informed consent
- Patients presenting with another arthropathy than anti-citrullinated peptide antibodies positive RA or osteoarthritis
- Patients not requiring arthrocentesis for medical reasons
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 |
|---|---|---|
| Joint puncturePatient requiring joint puncture for diagnostic or therapeutic reasons. | Procedure or surgery | Control group, Rheumatoid arthritis group |
Primary outcome
Presence of bacterial DNA by 16s PCR
Time frame: At the screening
Detection by 16s PCR of DNA of bacterial origin in synovial fluid specimens
Presence of a characteristic microbiota
Time frame: At the screening
Research of a characteristic microbiota of rheumatoid arthritis
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 14 Aug 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.
Emilie SHIPLEY, Dr principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Synovial Disorder, run by University Hospital, Bordeaux.
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 5 inclusion and 7 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Presence of bacterial DNA by 16s PCR (time frame: At the screening). The study lists 2 primary outcomes in all. 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 14 Aug 2019.