Effect of Tocilizumab on subclinical arterial inflammation and stiffness in patients with active rheumatoid arthritis (DAS28 > 3.2)

Effect of Tocilizumab on subclinical arterial inflammation and stiffness in patients with active rheumatoid arthritis (DAS28 > 3.2) - tocilizumab and arterial stiffness in RA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40306

Enrollment

Registered

2014-12-18

Start date

2015-02-12

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis in rheumatoid artritis patients

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients fulfilling the American College of Rheumatology criteria for RA at diagnosis • Active RA; DAS-28 score > 3.2 • Indication for treatment with tocilizumab. • Female/male patients 18-80 years of age. • Mentally able to understand the written information and to make the decision to participate. • Written Informed consent

Exclusion criteria

Exclusion criteria: • Pregnancy • Insulin dependent Diabetes Mellitus • Renal impairment (eGFR

Design outcomes

Primary

Measure	Time frame
Influence of disease activity on arterial stiffness as measured by pulse wave velocity in RA patients receiving tocilizumab	—

Secondary

Measure	Time frame
Pulse Wave Analysis (PWA) measuring central blood pressure (CBP) and augmentation index (AIx) , using Sphygmocor apparatus, effect on skin autofluorescence as a marker for tissue AGE accumulation and measuring endothelial progenitor cells (EPC's) and serum endothelial activation markers such as thrombomodulin (TM), soluble vascular cell adhesion molecule-1 (sVCAM-1), and von Willebrand factor (vWF) , and Lipopolysaccharide (LPS) stimulated cytokine (IL-1β, IL-6, IL-8, IL-10 and TNF-a) production in peripheral blood mononuclear cells. Throughout the study, medication and other influencing factors of endothelial dysfunction will be kept as steady as possible. Changes in traditional risk factors as smoking, hypertension, use of antihypertensive drugs or dyslipidemia and BMI will be recorded.	—

Measure

Time frame

Pulse Wave Analysis (PWA) measuring central blood pressure (CBP) and augmentation index (AIx) , using Sphygmocor apparatus, effect on skin autofluorescence as a marker for tissue AGE accumulation and measuring endothelial progenitor cells (EPC's) and serum endothelial activation markers such as thrombomodulin (TM), soluble vascular cell adhesion molecule-1 (sVCAM-1), and von Willebrand factor (vWF) , and Lipopolysaccharide (LPS) stimulated cytokine (IL-1β, IL-6, IL-8, IL-10 and TNF-a) production in peripheral blood mononuclear cells. Throughout the study, medication and other influencing factors of endothelial dysfunction will be kept as steady as possible. Changes in traditional risk factors as smoking, hypertension, use of antihypertensive drugs or dyslipidemia and BMI will be recorded.

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Countries

Netherlands

Outcome results