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

Completed

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01698515

Run by

Johns Hopkins University

People needed

20

Starts

2012-08-01

Expected to finish

2016-06-01

Last updated by the study team

2016-08-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients age 18-75, able to provide written informed consent
• Diagnosis of RA by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria
• Patients will not be required to be taking MTX unless they are being prescribed infliximab or golimumab as per approved indications. If taking background MTX, dose must be stable in 4 weeks and be expected to continue at the same dose for 3 months. Patients taking other nonbiological DMARDS will be excluded (leflunomide, hydroxychloroquine, sulfasalazine)
• Prednisone greater than or equal to 10 mg/day
• No prior treatment with a TNF inhibitor or other biological DMARD
• Starting anti-TNF agents with documented insurance authorization for coverage. The decision to start TNF agent and choice of particular agent will be based on the opinion of the treating rheumatologist.
• Standard starting dosing of agents will be:
• Infliximab (Remicade) 3 mg/kg IV; baseline, 2 wk, 6 wk, then q 8 wk
• Golimumab (Simponi) 50 mg subcutaneous (SC) q month
• Etanercept (Enbrel) 50 mg SC q week
• Adalimumab (Humira) 40 mg SC q every other week
• Certolizumab (Cimzia) 400 mg SC baseline, 2 wk, 4 week, then 200 mg q every other week or 400 mg q month.
• If it has been decided to use any other dosing regimen than those above, the patient will be excluded from participation.
• At least 14 teeth in the functional dentition
• Willing to practice contraception for the duration of the study period (as would be recommended to most patients starting these medications including MTX).
• Are considered eligible for a TNF inhibitor according to the following tuberculosis (TB) screening criteria:
• Have no history of latent or active TB prior to screening.
• Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
• Have had no recent close contact with a person with active TB.
• Have a negative (greater than 5mm induration) purified protein derivative (PPD) test within 6 weeks. Patients with a positive PPD will not be allowed to enroll regardless of exposure history or receipt of Bacille Calmette-Guérin (BCG).

You may not qualify if…

• Taking other nonbiological DMARD unless discontinued for at least 1 month: (sulfasalazine, hydroxychloroquine, leflunomide).
• Used systemic or oral topical antibiotics (inc. tetracyclines) within 30 d of enrollment.
• Taken phenytoin, cyclosporine, or coumadin within 3 months
• Known bleeding diathesis or coagulopathy
• Subjects with valvular heart disease, joint prosthesis, or other condition requiring routine antibiotic prophylaxis for dental procedures will not necessarily be excluded unless they are not willing to receive standard appropriate antibiotic prophylaxis before dental evaluations.
• No planned elective surgery within 4 months
• 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 positive PPD or other TB exclusions noted above.
• History of persistently indeterminate on repeat exams, Quantiferon TB Gold or other gamma-interferon releasing TB assays.

Where it is running

• Johns Hopkins Arthritis Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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