Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium (ParoPAR)
Primary Purpose
Rheumatoid Arthritis, Periodontitis
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
oral exam and
Sponsored by
About this trial
This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Periodontitis, rheumatoid arthritis, anti-interleukin 6, immunotherapy, inflammation, bacteria, periodontal sulci, periodontal pockets
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Toxicoman
- Antibiotic treatment in the last 2 months
- Legally protected patients
Sites / Locations
- Brest University Hospital
- Nantes University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
patient with parodontitis
Patient without parodontitis
Arm Description
Patient with rheumatoid arthritis and pparodontitis.
Patient with rheumatoid arthritis but periodontally healthy
Outcomes
Primary Outcome Measures
Clinical attachment level
Gain or loss obtained by periodontal probing.
Secondary Outcome Measures
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.
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.
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.
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.
Assessment of inflammation
Assessment of inflammation through Bleeding On Probing
Assessment of oral hygiene level
Assessment of oral hygiene level with plaque Index
Full Information
NCT ID
NCT01806974
First Posted
March 6, 2013
Last Updated
November 2, 2015
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01806974
Brief Title
Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium
Acronym
ParoPAR
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
as the recruitment rate was very low, a futility study was conducted and it was decided to discontinue inclusions
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Periodontitis
Keywords
Periodontitis, rheumatoid arthritis, anti-interleukin 6, immunotherapy, inflammation, bacteria, periodontal sulci, periodontal pockets
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with parodontitis
Arm Type
Other
Arm Description
Patient with rheumatoid arthritis and pparodontitis.
Arm Title
Patient without parodontitis
Arm Type
Other
Arm Description
Patient with rheumatoid arthritis but periodontally healthy
Intervention Type
Other
Intervention Name(s)
oral exam and
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical attachment level
Description
Gain or loss obtained by periodontal probing.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Detection of periodontopathogenic germs
Description
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.
Time Frame
6 month
Title
Quantification of periodontopathogenic germs
Description
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.
Time Frame
6 month
Title
Detection of inflammation markers in the gingival fluid
Description
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.
Time Frame
6 month
Title
Quantification of inflammation markers in the gingival fluid
Description
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.
Time Frame
6 month
Title
Assessment of inflammation
Description
Assessment of inflammation through Bleeding On Probing
Time Frame
6 month
Title
Assessment of oral hygiene level
Description
Assessment of oral hygiene level with plaque Index
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Toxicoman
Antibiotic treatment in the last 2 months
Legally protected patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assem SOUEIDAN
Organizational Affiliation
Nantes UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brest University Hospital
City
Brest
Country
France
Facility Name
Nantes University Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium
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