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Influence of rituximab on endothelial dysfunction in RA.


- candidate number11251
- NTR NumberNTR3327
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-feb-2012
- Secondary IDs2011-000279-15 Eudra-CT
- Public TitleInfluence of rituximab on endothelial dysfunction in RA.
- Scientific TitleDoes reduction of disease activity influence endothelial function in patients with rheumatoid arthritis? (An open label pilot study with rituximab)
- ACRONYM
- hypothesisTreatment of active rheumatoid arthritis with rituximab will positively influence endothelial function.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Rituximab
- Inclusion criteria1. Patients fulfilling ACR criteria for RA;
2. DAS-28 score >3.2;
3. Indication for treatment with rituximab;
4. Female/male patients age 18-80yrs;
5. Mentally able to understand the written information and to make the decision to participate;
6. Informed consent.
- Exclusion criteria1. Diabetes mellitus;
2. Renal impairment (eGFR< 60ml/min);
3. Recent Surgery;
4. Myocardial Infacrction or sepsis in the past three months.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 12-mei-2011
- planned closingdate12-mei-2012
- Target number of participants15
- InterventionsRA patients are treated with rituximab for active disease (DAS28> 3.2). The rituximab is administered in two separate gifts of 1000mg each with an interval of two weeks. Markers for premature atherosclerosis (such as endothelial activation markers, pulse wave analysis, intima media thickness and advanced glycation end products) are measured before administration of rituximab and 4 months after administration of rituximab.
Patients serve as their own controls 4 months after administration of the rituximab.
- Primary outcomeInfluence of rituximab on endothelial dysfunction as measured by pulse wave analysis.
- Secondary outcomeInfluence of rituximab on endothelial activation markers such as Thrombomodulin, von Willebrand factor, soluble vascular cellular adhesion molecule (all measured by Elisa), intima media thickness (measured by B-mode ultrasound at the carotid artery) and advanced glycation end products in the skin, as measured by autofluorescence reader.
- TimepointsT=0: Before administration of rituximab;
T=1: 4 months after administration of rituximab.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lodewijk Groot, de
- CONTACT for SCIENTIFIC QUERIES Lodewijk Groot, de
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Roche
- PublicationsN/A
- Brief summaryThis study investigates the influence of rituximab on endothelial dysfunction in patients with active RA (DAS-28>3.2).
- Main changes (audit trail)
- RECORD29-feb-2012 - 16-mrt-2012


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