rheumatoid arthritis, periodontitis (PD)
Conditions
Interventions
sarilumab
Sponsors
sanofi-genzyme
Eligibility
Inclusion criteria
Inclusion criteria: RA fulfilling the European League Against Rheumatism (EULAR) 2010 classification criteria. Active RA is defined as a DAS28-CRP > 2.9 and the presence of active arthritis (= 2 swollen joints) Moderate to severe PD. Initiation of treatment with Sarilumab.
Exclusion criteria
Exclusion criteria: smoking diabetes mellitus type I or II ositive pregnancy test or breast feeding antibiotic treatment in the previous 3 months surgical periodontal therapy within the previous 3 months fewer than 15 teeth need for treatment of extensive tooth decay, tooth abscesses or other oral infections, such as teeth needing root canal therapy serious infections. opportunistic infection in the preceding 3 months. Evidence of active or latent bacterial infections at the time enrolment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection. Current clinical or laboratory evidence of active tuberculosis (TB). History of active TB treated within the last 3 years. Heavy alcohol consumption (>3 drinks/day). Absolute neutrophil count less than 1 x 109/L. Platelet count below 50 x 103/µL. Liver cirrhosis or severe renal insufficiency. Patients for whom Sarilumab is contra-indicated as described in the local label (SmPc). Patients currently participating in any interventional clinical trials. Previous experience with Sarilumab through a clinical trial or regular treatment. Concomitant use of any biologic DMARDs etanercept, adalimumab, infliximab, anakinra, rituximab, abatacept, tocilizumab, certolizumab, golimumab) or the tsDMARDs tofacitinib, baracitinib or filgotinib or any classical DMARD other than methotrexate or leflunomide. Concurrent treatment with prednisone > 10 mg orally. Change in prednisone dosage within 4 weeks before the baseline visit. Treatment with intra-muscular, intra-articular or intravenous prednisone 4 weeks before the baseline visit. Uncooperative or any condition that could make the patient potentially noncompliant to the study procedures, etc, and, as applicable in the Netherlands, individuals who are institutionalized due to regulatory or legal order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall safety periodontal safety improvement of periodontal condition | — |
Secondary
| Measure | Time frame |
|---|---|
| biomarkers of periodontitis and periodontitis associated autoimmunity | — |
Contacts
Public ContactRogier Thurlings
Radboudumc
Outcome results
None listed