Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01806974
• Other study ID #: RC12_0172
• Status: Terminated
• Phase: Phase 4
• First received: March 6, 2013
• Last updated: November 2, 2015
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: FRANCE : ANSM (Agence National de Sécurité du Médicament et des produits de santé)
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Periodontal Pocket
• Periodontitis
• Rheumatoid Arthritis

Intervention

Other:
• oral exam and
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.

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level	Gain or loss obtained by periodontal probing.	6 month	No
Secondary	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.	6 month	No
Secondary	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.	6 month	No
Secondary	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.	6 month	No
Secondary	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.	6 month	No
Secondary	Assessment of inflammation	Assessment of inflammation through Bleeding On Probing	6 month	No
Secondary	Assessment of oral hygiene level	Assessment of oral hygiene level with plaque Index	6 month	No