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

NCT01806974 | Terminated Phase 4

• 1 other identifier: RC12_0172
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis; Periodontitis

Keywords

Periodontitis; rheumatoid arthritis; anti-interleukin 6; immunotherapy; inflammation; bacteria; periodontal sulci; periodontal pockets

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level

  Gain or loss obtained by periodontal probing.

  6 month

Secondary Outcomes (6)

• Detection of periodontopathogenic germs

  6 month

• Quantification of periodontopathogenic germs

  6 month

• Detection of inflammation markers in the gingival fluid

  6 month

• Quantification of inflammation markers in the gingival fluid

  6 month

• Assessment of inflammation

  6 month

Study Arms (2)

patient with parodontitis

OTHER

Patient with rheumatoid arthritis and pparodontitis.

Other: oral exam and

Patient without parodontitis

OTHER

Patient with rheumatoid arthritis but periodontally healthy

Other: oral exam and

Interventions

oral exam and OTHER

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 parodontitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

Brest University Hospital

Brest, France

Location

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Periodontitis; Inflammation; Periodontal Pocket

Interventions

Diagnosis, Oral

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Assem SOUEIDAN

  Nantes UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

FR (2)