Clinical trial NCT01806974: Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Periodontitis
Keywords: Periodontitis
rheumatoid arthritis
anti-interleukin 6
immunotherapy
inflammation
bacteria
periodontal sulci
periodontal pockets
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Clinical attachment level
timeFrame: 6 month
Secondary outcomes:
measure: Detection of periodontopathogenic germs
timeFrame: 6 month
measure: Quantification of periodontopathogenic germs
timeFrame: 6 month
measure: Detection of inflammation markers in the gingival fluid
timeFrame: 6 month
measure: Quantification of inflammation markers in the gingival fluid
timeFrame: 6 month
measure: Assessment of inflammation
timeFrame: 6 month
measure: Assessment of oral hygiene level
timeFrame: 6 month
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes UH
name: Assem SOUEIDAN
role: PRINCIPAL_INVESTIGATOR
References: