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

Completed

Conditions: atherosclerosis in rheumatoid artritis patients
10003816
10023213
10003216

Registration Number: NL-OMON40306

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

• Pregnancy
• Insulin dependent Diabetes Mellitus
• Renal impairment (eGFR <30ml/min)
• MI or sepsis in the past three months
• Unable to lay flat for 30-45 minutes for the PWV measurement

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Influence of disease activity on arterial stiffness as measured by pulse wave<br /><br>velocity in RA patients receiving tocilizumab</p><br>

Secondary Outcome Measures

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