Oral Health Assessment in Rheumatoid Arthritis and Other Autoimmune Diseases-- Anti- TNF Substudy
The objective of this study is to evaluate the effect of 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 RA and oral clinical variables.
The purposes of the study are to:
- Determine if oral periodontal parameters are affected by TNF inhibition;
- Examine relationships between periodontal variables and RA variables with TNF inhibition;
- Determine if there may be potential early response markers of clinical RA response seen using ultrasensitive analysis of oral or serum cytokines.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Oral Health Assessment in Rheumatoid Arthritis and Other Autoimmune Diseases-- Anti- TNF Substudy|
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
anti - TNF subgroup
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. We are not requesting anti-TNFs or other drugs specifically for patients enrolled in this study from any 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.
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 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 paperpoints 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 we will obtain blood to be assayed for 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698515
|United States, Maryland|
|Johns Hopkins Arthritis Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Malini Moni 410-550-9826 firstname.lastname@example.org|
|Principal Investigator: Clifton Bingham|
|Principal Investigator:||Clifton O Bingham, MD||Johns Hopkins University|