Completed

Oral Health Assessment in Rheumatoid Arthritis and Other Autoimmune Diseases-- Anti- TNF Substudy

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Arthritis+6

+ Autoimmune Diseases

+ Connective Tissue Diseases

From 18 to 75 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: August 2012
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: August 31, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorJohns Hopkins University
Last updated: August 31, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue DiseasesArthritis, Rheumatoid

Criteria

20 inclusion criteria required to participate
Adalimumab (Humira) 40 mg SC q every other week

Adult patients age 18-75, able to provide written informed consent

Are considered eligible for a TNF inhibitor according to the following tuberculosis (TB) screening criteria

At least 14 teeth in the functional dentition

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10 exclusion criteria prevent from participating
Comorbid condition that in the opinion of the investigator would preclude administration of a TNF inhibitor or the performance of oral examinations

History of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidiomycosis prior to screening

History of persistently indeterminate on repeat exams, Quantiferon TB Gold or other gamma-interferon releasing TB assays

History of positive PPD or other TB exclusions noted above

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Johns Hopkins Arthritis Center

Baltimore, United StatesOpen Johns Hopkins Arthritis Center in Google Maps
CompletedOne Study Center