Influence of rituximab on endothelial dysfunction in RA.

Does reduction of disease activity influence endothelial function in patients with rheumatoid arthritis? (An open label pilot study with rituximab)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21369

Enrollment

Registered

2012-02-29

Start date

2011-05-12

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 Rituximab

Interventions

RA 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 atherosc

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. Diabetes mellitus; 2. Renal impairment (eGFR< 60ml/min); 3. Recent Surgery; 4. Myocardial Infacrction or sepsis in the past three months.

Design outcomes

Primary

Measure	Time frame
Influence of rituximab on endothelial dysfunction as measured by pulse wave analysis.	—

Secondary

Measure	Time frame
Influence 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.	—

Contacts

Public ContactLodewijk Groot, de

PO BOX 30001

lodewijk.de.groot@umcg.nl+31 (0)6 15108063

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)