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

This study has been terminated.
(as the recruitment rate was very low, a futility study was conducted and it was decided to discontinue inclusions)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01806974
First Posted: March 8, 2013
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  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: None (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:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Clinical attachment level [ Time Frame: 6 month ]
    Gain or loss obtained by periodontal probing.


Secondary Outcome Measures:
  • Detection of periodontopathogenic germs [ Time Frame: 6 month ]
    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 ]
    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 ]
    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 ]
    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 ]
    Assessment of inflammation through Bleeding On Probing

  • Assessment of oral hygiene level [ Time Frame: 6 month ]
    Assessment of oral hygiene level with plaque Index


Enrollment: 16
Study Start Date: December 2012
Study Completion Date: June 2015
Primary Completion Date: June 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806974


Locations
France
Brest University Hospital
Brest, France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Assem SOUEIDAN Nantes UH
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01806974     History of Changes
Other Study ID Numbers: RC12_0172
First Submitted: March 6, 2013
First Posted: March 8, 2013
Last Update Posted: November 3, 2015
Last Verified: November 2015

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
Periodontitis
Periodontal Pocket
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases