Oral Health Assessment in Rheumatoid Arthritis and Other Autoimmune Diseases-- Anti- TNF Substudy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Autoimmune Diseases
Study type: Observational

Summary: 
      The objective of this study is to evaluate the effect of Tumor Necrosis Factor (TNF)
      inhibition on oral parameters in patients with RA and to examine changes in levels of
      proinflammatory cytokines in serum, gingival crevicular fluid (GCF), and saliva at an early
      time point (6-8 wk) and a later time point (14-16 wk) after the initiation of therapy in
      relation to concomitant assessment of Rheumatoid arthritis (RA) and oral clinical variables.

      The purposes of the study are to:

        1. Determine if oral periodontal parameters are affected by TNF inhibition;

        2. Examine relationships between periodontal variables and RA variables with TNF
           inhibition;

        3. Determine if there may be potential early response markers of clinical RA response seen
           using ultrasensitive analysis of oral or serum cytokines.
    

Detailed description: 
      20 subjects with RA, who are starting TNF inhibitors based on the decision of their treating
      rheumatologist, will be recruited only from the existing clinic population who receive
      ongoing clinical care at the Johns Hopkins Arthritis Center. No patients from outside the
      clinic will be recruited. No medications will be supplied through the study.

      Study duration and numbers of visits: Patients will be followed through 14-16 weeks after the
      initiation of TNF inhibitor. Each patient will be seen for 4 visits: a screening visit, a
      baseline visit, a follow up visit between 6-8 weeks after TNF inhibitor initiation, and a
      final visit at weeks 14-16 after TNF inhibitor initiation. At each visit the procedures noted
      below will be performed. Should a patient discontinue the TNF inhibitor for any reason, a
      final assessment at the time of stopping will be requested.

      Rheumatology Assessments: Subjects will complete standard clinical assessment questionnaires
      with age, race, demographic status, past medical and surgical history, co-morbid diseases,
      signs and symptoms of arthritis,. Multi-dimensional Health Assessment Questionnaire (MD-HAQ)
      and short form survey (SF)-36. Baseline joint counts for swollen, tender, and deformed or
      operated joints will be recorded. A Schirmer test to measure conjunctival tear production
      will be performed.

      Oral Health and Periodontal Evaluation: Subjects will have a comprehensive oral health and
      periodontal evaluation. Subjects will complete standardized oral health questionnaires to
      assess dental health (including caries, tooth loss, periodontitis, dry mouth, and TMD) dental
      hygiene practices, prior dental procedures, , smoking, and access to dental care. Subjects
      will undergo a comprehensive dental evaluation including oral mucosal assessment, including
      plaque, gingivitis, and periodontal indices recorded at 6 sites per tooth, as well as an
      evaluation for xerostomia and temporomandibular joint (TMJ) function. Gingival crevicular
      fluid will be collected on paper points placed into the periodontal sulcus of the 2 most
      severely affected teeth and 2 sites with the least amount of periodontal inflammation.
      Unstimulated saliva will be collected over 5 minutes following GCF collection.

      Laboratory Assessments: At each visit the investigators will obtain blood to be assayed for
      C-reactive protein (CRP) and other biomarkers. These will include the evaluation of a panel
      of inflammatory cytokines that will be tested in the blood, saliva, and GCF, to determine how
      these may change over time in response to TNF antagonist therapy for RA. .

      Withdrawal Criteria: Patients may withdraw consent at any time and no longer participate in
      the oral examinations or other assessments. Patients who discontinue TNF agents for reasons
      of tolerability or lack of efficacy will be asked to return for a study termination visit for
      a follow up oral examination.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        20 subjects with RA, who are starting TNF inhibitors based on the decision of their
        treating rheumatologist, will be recruited from the clinic. Patients will be starting
        commercially available anti-TNF agents that have already been authorized for insurance
        coverage. The investigators are not requesting anti-TNFs or other drugs specifically for
        patients enrolled in this study from Janssen or any other pharmaceutical company. Patients
        will also continue on their background MTX and corticosteroids if they are taking these
        agents, and MTX will be required for patients taking Infliximab or Golimumab as per
        approved indication. No medications will be supplied through the study.