NL-OMON25212尚未招募不适用
Effect of Sarilumab on periodontitis and related biomarkers in rheumatoid arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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