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

This study is currently recruiting participants.
Verified March 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01806974
First received: March 6, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Periodontitis
 Other: oral exam and
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Clinical attachment level [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Gain or loss obtained by periodontal probing.


Secondary Outcome Measures:
  • Detection of periodontopathogenic germs [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Assessment of inflammation through Bleeding On Probing

  • Assessment of oral hygiene level [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Assessment of oral hygiene level with plaque Index


Estimated Enrollment: 47
Study Start Date: December 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
patient with parodontitis
Patient with rheumatoid arthritis and pparodontitis.
 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.
Patient without parodontitis
Patient with rheumatoid arthritis but periodontally healthy
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806974

Contacts
Contact: Assem SOUEIDAN, PhD assem.soueidan@chu-nantes.fr

Locations
France
Brest University Hospital Not yet recruiting
Brest, France
Contact: Julien DEMOERSMAN            
Principal Investigator: Jacques-Olivier PERS            
Sub-Investigator: Julien DEMOERSMAN            
Sub-Investigator: Alain SARAUX            
Nantes University Hospital Recruiting
Nantes, France
Contact: Assem SOUEIDAN         assem.soueidan@chu-nantes.fr    
Sub-Investigator: Yves MAUGARS            
Sub-Investigator: Zahi BADRAN            
Sub-Investigator: Céline BORIES            
Sub-Investigator: Jean Marie BERTHELOT            
Sub-Investigator: Joëlle GLEMAREC            
Principal Investigator: Assem SOUEIDAN            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Assem SOUEIDAN Nantes UH
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01806974     History of Changes
Other Study ID Numbers: RC12_0172
Study First Received: March 6, 2013
Last Updated: March 6, 2013
Health Authority: FRANCE : ANSM (Agence National de Sécurité du Médicament et des produits de santé)

Keywords provided by Nantes University Hospital:
Periodontitis
rheumatoid arthritis
anti-interleukin 6
immunotherapy
 inflammation
bacteria
periodontal sulci
periodontal pockets

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Periodontal Pocket
Periodontitis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013