Rheumatoid ArthritisNCT01698515
Oral Health Assessment in Rheumatoid Arthritis and Other Autoimmune Diseases-- Anti- TNF Substudy
An observational study of Rheumatoid Arthritis, run by Johns Hopkins University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 20Show fewer
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Arthritis Center
Baltimore, Maryland, 21224
About this study
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:
- 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNF subgroup | 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. -------------------------------------------------------------------------------- |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
- Investigators
- Clifton O Bingham, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698515
- Sponsor's protocol ID
- OHARA_1898
- Status last verified
- Aug 2016
- First submitted
- 1 Oct 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Assessment in Rheumatoid Arthritis and Other Autoimmune Diseases-- Anti- TNF Substudy
- ClinicalTrials.gov ID
- NCT01698515
- Acronym / sponsor ID
- OHARA_1898
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- Aug 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-TNF subgroup | – | –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. -------------------------------------------------------------------------------- |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifton O Bingham, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.