Rheumatoid ArthritisPhase 4ParoPARNCT01806974
Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium
A Phase 4 study testing oral exam and in people with Rheumatoid Arthritis and Periodontitis, run by Nantes University Hospital at 2 sites in France.
Trial summary
Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Periodontitis
- What is being tested?
- oral exam and
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2012to Jun 2015
- Phase
- Phase 4
- 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
Who may be able to join
- patient over 18 years presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is prescribed.
- At least 18 permanent teeth in the mouth at least 3 teeth with a healthy periodontal status
- Having expressed their written free and informed consent
Who cannot join
- Hypersensitivity to any of the following components : tocilizumab, saccharose, polysorbate 80, phosphate disodique dodécahydrate, phosphate monosodique dehydrate
- Severe or active infections
- Systemic Pathology affecting the immune system including Sjögren's syndrome
- Surgery in the previous month
- HIV positive
- Alcoholic
Show all 9Show fewer
- Toxicoman
- Antibiotic treatment in the last 2 months
- Legally protected patients
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Multicenter, Prospective Study, on the Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on: - Healthy and Pathological Periodontium - The Level of Expression of Some Markers of Inflammation and Periodontal Pathogenic Bacteria in Periodontal Sulci and Periodontal Pockets
Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial.
These new biotherapies could have an impact on periodontal status
Read more
- either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,
- or a positive modulation of the host response by inhibiting bone resorption of the alveolar process.
To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.
- Conditions
- Rheumatoid Arthritis, Periodontitis
- Being tested
- oral exam and
- Keywords
- Periodontitis, rheumatoid arthritis, anti-interleukin 6, immunotherapy, inflammation, bacteria, periodontal sulci, periodontal pockets
- Medical subject headings
- Arthritis, Rheumatoid, Periodontitis, Inflammation, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral exam andOther
The study will be conducted with patient presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is planned. Each patient will benefit a record oral exam that will evaluate his periodontal status and on a possible periodontitis associated. Bacterial samples and cytokine will be realized (in defined periodontal pocket or in the most affected periodontal pocket depending of the periodontal status of patients) before the IL6 biotherapy and 6 month after. A periodontal charting will be realized at the same time.
| Study group | Role | What they receive |
|---|---|---|
| patient with parodontitis | Other | Patient with rheumatoid arthritis and pparodontitis. Receives: Other: oral exam and |
| Patient without parodontitis | Other | Patient with rheumatoid arthritis but periodontally healthy Receives: Other: oral exam and |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
Gain or loss obtained by periodontal probing.
Measured: 6 month
Secondary outcomes (6)
Detection of periodontopathogenic germs
Detection of periodontopathogenic germs by RT - PCR - Q wich the bacterial samples will be made at the outset of the study and 6 month after the beginning of anti IL6 treatment.
Measured: 6 month
Quantification of periodontopathogenic germs
Quantification of periodontopathogenic germs by RT - PCR - Q wich the bacterial samples will be made at the outset of the study and 6 month after the beginning of anti IL6 treatment.
Measured: 6 month
Detection of inflammation markers in the gingival fluid
Detection and quantification of inflammation markers in the gingival fluid : IL-1, IL-6, IL-8, IL-10, IL-12, IL-15, IL-17, TGF- beta, TNF-alpha, IL-4 et IFn-gamma.
Measured: 6 month
Quantification of inflammation markers in the gingival fluid
Quantification of inflammation markers in the gingival fluid : IL-1, IL-6, IL-8, IL-10, IL-12, IL-15, IL-17, TGF- beta, TNF-alpha, IL-4 et IFn-gamma.
Measured: 6 month
Assessment of inflammation
Assessment of inflammation through Bleeding On Probing
Measured: 6 month
Assessment of oral hygiene level
Assessment of oral hygiene level with plaque Index
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: as the recruitment rate was very low, a futility study was conducted and it was decided to discontinue inclusions
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 Nantes University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Assem SOUEIDAN, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806974
- Sponsor's protocol ID
- RC12_0172
- Acronym
- ParoPAR
- Status last verified
- Nov 2015
- First submitted
- 6 Mar 2013
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Study, on the Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on: - Healthy and Pathological Periodontium - The Level of Expression of Some Markers of Inflammation and Periodontal Pathogenic Bacteria in Periodontal Sulci and Periodontal Pockets
- ClinicalTrials.gov ID
- NCT01806974
- Acronym / sponsor ID
- ParoPAR / RC12_0172
- Conditions
- Rheumatoid Arthritis, Periodontitis
- Keywords
- Periodontitis, rheumatoid arthritis, anti-interleukin 6, immunotherapy, inflammation, bacteria, periodontal sulci, periodontal pockets
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: as the recruitment rate was very low, a futility study was conducted and it was decided to discontinue inclusions
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Mar 2013 (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 and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial.
These new biotherapies could have an impact on periodontal status
- either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,
- or a positive modulation of the host response by inhibiting bone resorption of the alveolar process.
To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with parodontitis | Other | Other: oral exam andPatient with rheumatoid arthritis and pparodontitis. |
| Patient without parodontitis | Other | Other: oral exam andPatient with rheumatoid arthritis but periodontally healthy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient over 18 years presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is prescribed.
- At least 18 permanent teeth in the mouth at least 3 teeth with a healthy periodontal status
- Having expressed their written free and informed consent
Key exclusion criteria (9 listed)
- Hypersensitivity to any of the following components : tocilizumab, saccharose, polysorbate 80, phosphate disodique dodécahydrate, phosphate monosodique dehydrate
- Severe or active infections
- Systemic Pathology affecting the immune system including Sjögren's syndrome
- Surgery in the previous month
- HIV positive
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 |
|---|---|---|
| oral exam andThe study will be conducted with patient presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is planned. Each patient will benefit a record oral exam that will evaluate his periodontal status and on a possible periodontitis associated. Bacterial samples and cytokine will be realized (in defined periodontal pocket or in the most affected periodontal pocket depending of the periodontal status of patients) before the IL6 biotherapy and 6 month after. A periodontal charting will be realized at the same time. | Other | Patient without parodontitis, patient with parodontitis |
Primary outcome
Clinical attachment level
Time frame: 6 month
Gain or loss obtained by periodontal probing.
6 secondary outcomes
Detection of periodontopathogenic germs
Time frame: 6 month
Quantification of periodontopathogenic germs
Time frame: 6 month
Detection of inflammation markers in the gingival fluid
Time frame: 6 month
Quantification of inflammation markers in the gingival fluid
Time frame: 6 month
Assessment of inflammation
Time frame: 6 month
Assessment of oral hygiene level
Time frame: 6 month
Results and safety
The study was stopped early (reason given: as the recruitment rate was very low, a futility study was conducted and it was decided to discontinue inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
Assem SOUEIDAN principal investigator
Nantes UH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral exam and in people with Rheumatoid Arthritis and Periodontitis, run by Nantes University Hospital at 2 sites 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 9 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: stopped early, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: as the recruitment rate was very low, a futility study was conducted and it was decided to discontinue inclusions). Results are not available in the source record.
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?
Clinical attachment level (time frame: 6 month). 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 3 Nov 2015.