Sarilumab reduces PD severity in RA patients with PD
ID
Bron
Verkorte titel
Aandoening
rheumatoid arthritis, periodontitis (PD)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
overall safety
periodontal safety
improvement of periodontal condition
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Sarilumab reduces PD severity in RA patients with PD
Onderzoeksopzet
baseline, 1, 3 and 6 months (primary endpoint).
Onderzoeksproduct en/of interventie
sarilumab
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8579 |
| Ander register | CMO Arnhem-Nijmegen : 2019-6031 |