Influence of everolimus on atherosclerosis in RA.

Assessment of endothelial dysfunction and atherosclerosis in patients with Rheumatoid Arthritis. A pilot intervention study with everolimus.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28147

Enrollment

Registered

2010-06-21

Start date

2010-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Rheumatoid arthritis, endothelial activation, endothelial dysfunction, intima media thickness, cardio-vascular disease, everolimus

Interventions

Patients are treated with everolimus for six months, target plasma concentration of everolimus 6-10 ng/ml.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Fulfill the American College of Rheumatology criteria for RA; 2. DAS-28 score>3,2; 3. Female/male patients 18-80 years of age; 4. Mentally able to understand the written information and to make the decision to participate; 5. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding status; 2. Diabetes mellitus (fasting blood glucose =/> 7.0 mmol/L); 3. Renal impairment (eGFR <60ml/min); 4. Recent Surgery; 5. MI or sepsis in the past three months.

Design outcomes

Primary

Measure	Time frame
1. Endothelial activation as measured by von Willebrand factor, soluble vascular adhesion molecule, thrombomodulin; 2. Endothelial dysfunction as measured by small artery elasticity; 3. Premature atherosclerosis as measured by intima media thickness.	—

Secondary

Measure	Time frame
1. Effect of everolimus on RA; 2. Drop-out due to side effects of everolimus.	—

Contacts

Public ContactLodewijk Groot, de

Postbus 30001

lodewijk.de.groot@reuma.umcg.nl+31 (0)50 36112945

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)