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Influence of everolimus on atherosclerosis in RA.


- candidate number8165
- NTR NumberNTR2376
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jun-2010
- Secondary IDsNL27732.042.09 ABR
- Public TitleInfluence of everolimus on atherosclerosis in RA.
- Scientific TitleAssessment of endothelial dysfunction and atherosclerosis in patients with Rheumatoid Arthritis. A pilot intervention study with everolimus.
- ACRONYMInfluence of everolimus on premature atherosclerosis in RA patients
- hypothesisCardio-vascular disease is increased in RA. Everolimus has shown to have beneficial effects on endothelial function in cardiac tranplant patients and renal transplant patients. We want to study the effect of everolimus in patients with active RA.
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Rheumatoid arthritis, Endothelial dysfunction, Everolimus, Endothelial activation, Intima media thickness
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate1-mrt-2011
- Target number of participants15
- InterventionsPatients are treated with everolimus for six months, target plasma concentration of everolimus 6-10 ng/ml.
- Primary outcome1. 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 outcome1. Effect of everolimus on RA;
2. Drop-out due to side effects of everolimus.
- TimepointsAll parameters are measured at t=0 and t= 6 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lodewijk Groot, de
- CONTACT for SCIENTIFIC QUERIES Lodewijk Groot, de
- Sponsor/Initiator Novartis Pharma, University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Novartis
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD21-jun-2010 - 28-jun-2010


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