No registrations found.
ID
Source
Brief title
Health condition
rheumatoid arthritis, periodontitis (PD)
Sponsors and support
Intervention
Outcome measures
Primary outcome
overall safety
periodontal safety
improvement of periodontal condition
Secondary outcome
biomarkers of periodontitis and periodontitis associated autoimmunity
Background summary
Rationale: Anti-IL6 receptor blocking therapy has been associated with reduced inflammation in patients with rheumatoid arthritis (RA), but this has not been shown for RA patients with moderate to severe periodontitis (PD).
Primary objective: to assess the effect of Sarilumab on the periodontal condition in patients with RA and concomitant moderate to severe PD.
Secondary exploratory objectives: PD biomarkers and PD related autoimmune biomarkers.
Study objective
Sarilumab reduces PD severity in RA patients with PD
Study design
baseline, 1, 3 and 6 months (primary endpoint).
Intervention
sarilumab
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8579 |
| Other | CMO Arnhem-Nijmegen : 2019-6031 |